A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT

The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.
The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections.
The study will include newborns and infants up to 9 months of age who are admitted in the hospital.
The study is conducted in 2 parts: Part A and Part B.
In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount.
In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.

开始日期2024-09-25

申办/合作机构

Pfizer Inc.

[+1]

NCT05639647 / Recruiting临床2期

A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION

The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
The study is seeking participants who are:
* 9 months to less than 18 years of age
* Hospitalized
* Suspected/known to have a gram-negative infection
* Receiving intravenous (iv, given directly into a vein) antibiotics
* Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs.
* Participants will receive either ATM-AVI or best available therapy (BAT).
* Both therapies will be given through a vein.
* Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of MTZ. - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion.
* The iv dose of ATM-AVI will be based on the participant's weight and kidney function.
* The study doctor will determine the iv dose of BAT.
* During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities.
* Starting on day 4, the study doctor will decide if participants may be switched to oral therapy.
* Participants will receive a maximum of 14 days of ATM-AVI treatment.
* After discharge from the hospital, 1 study visit may be required.
* Depending on the participant's response, the study duration will be from 33 to 50 days.
* The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.

开始日期2023-04-18

申办/合作机构

Pfizer Inc.

NCT04973826 / Completed临床1期

A PHASE I, SINGLE CENTER, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM ADMINISTERED AS SINGLE AND REPEATED INTRAVENOUS DOSES IN HEALTHY CHINESE PARTICIPANTS

A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.

开始日期2021-08-20

申办/合作机构

Pfizer Inc.

100 项与阿维巴坦钠/氨曲南相关的临床结果

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100 项与阿维巴坦钠/氨曲南相关的专利（医药）

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项与阿维巴坦钠/氨曲南相关的文献（医药）

2024-10-01·LANCET INFECTIOUS DISEASES

Aztreonam–avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial

Article

作者: Chen, Gang ; Wible, Michele ; Daikos, George L ; Luckey, Alison ; Leaney, Joanne L ; Liang, Lu ; Chow, Joseph W ; Paul, Mical ; Aksoy, Firdevs ; Torre-Cisneros, Julian ; Carmeli, Yehuda ; Gumenchuk, Illia ; Titov, Ivan ; Goossens, Herman ; Jiménez-Rodríguez, Rosa-María ; Pyptiuk, Oleksandr ; Wang, Minggui ; Cisneros, José Miguel ; Lammens, Christine ; Zhao, Yongjie ; Arhin, Francis F ; Pypstra, Rienk ; Rogers, Halley ; Malhotra-Kumar, Surbhi ; Singer, George ; Rodríguez-Baño, Jesús ; Bonten, Marc

BACKGROUND:

There is a need for additional therapeutic options for serious infections caused by Gram-negative pathogens. In the phase 3, descriptive REVISIT study, we investigated the safety and efficacy of aztreonam-avibactam in the treatment of complicated intra-abdominal infections or hospital-acquired pneumonia or ventilator-associated pneumonia (HAP-VAP) caused, or suspected to be caused, by Gram-negative bacteria.

METHODS:

This prospective, multinational, open-label, central assessor-masked study enrolled adults who were hospitalised with a complicated intra-abdominal infection or HAP-VAP. Patients were randomly allocated via block randomisation using interactive response technology stratified by infection type in a 2:1 ratio to aztreonam-avibactam (with metronidazole for complicated intra-abdominal infection) or meropenem with or without colistin for 5-14 days for complicated intra-abdominal infection or 7-14 days for HAP-VAP. The primary endpoint was clinical cure at the test-of-cure visit (within 3 days before or after day 28) in the intention-to-treat (ITT) population. Secondary endpoints included 28-day mortality in the ITT population and safety in patients in the ITT population who received study drug (safety analysis set). No formal hypothesis testing was planned. The study was registered with ClinicalTrials.gov (NCT03329092) and EudraCT (2017-002742-68) and is complete.

FINDINGS:

Between April 5, 2018, and Feb 23, 2023, we screened 461 patients. 422 patients were enrolled and randomly allocated (282 in the aztreonam-avibactam group and 140 in the meropenem group, forming the ITT analysis set), of whom ten patients (seven in the aztreonam-avibactam group and three in the meropenem group) were randomly allocated but did not receive study treatment. 271 (64%) of 422 patients had at least one Gram-negative pathogen from an adequate specimen identified at baseline. The most frequent baseline pathogens were Enterobacterales (252 [93%] of 271). Overall, 19 (24%) of 80 isolates tested for carbapenemases were carbapenemase-positive (serine, metallo-β-lactamase, or both). 193 (68·4%) of 282 patients in the aztreonam-avibactam group and 92 (65·7%) of 140 in the meropenem group had clinical cure at the test-of-cure visit (treatment difference 2·7% [95% CI -6·6 to 12·4]). For patients with complicated intra-abdominal infection, the adjudicated clinical cure rate was 76·4% (159 of 208) for the aztreonam-avibactam group and 74·0% (77 of 104) for the meropenem group. Cure rates in patients with HAP-VAP were 45·9% (34 of 74) for aztreonam-avibactam and 41·7% (15 of 36) for meropenem. 28-day all-cause mortality rates were 4% (12 of 282) for aztreonam-avibactam and 7% (ten of 140) for meropenem; in patients with complicated intra-abdominal infection, mortality was 2% (four of 208) and 3% (three of 104) for aztreonam-avibactam and meropenem, respectively, and in patients with HAP-VAP, mortality was 11% (eight of 74) and 19% (seven of 36), respectively. Aztreonam-avibactam was generally well tolerated, and safety findings were consistent with the known safety profile of aztreonam monotherapy. There were no treatment-related serious adverse events in the aztreonam-avibactam group.

INTERPRETATION:

These phase 3 efficacy and safety data provide support for aztreonam-avibactam as a potential therapeutic option for complicated intra-abdominal infection or HAP-VAP caused by Gram-negative bacteria.

FUNDING:

Pfizer.

2024-10-01·JOURNAL OF ANTIBIOTICS

Minimum inhibitory concentrations of aztreonam–avibactam, ceftazidime–avibactam and meropenem in clinical isolates of Klebsiella pneumoniae harboring carbapenemase genes

Article

作者: Sidorenko, Sergey ; Ageevets, Irina ; Sulian, Ofelia ; Avdeeva, Alisa ; Chulkova, Polina ; Gostev, Vladimir ; Alieva, Kamilla ; Ageevets, Vladimir ; Golikova, Maria

This study was aimed at understanding the distributions of the MICs (minimum inhibitory concentrations) of aztreonam-avibactam, ceftazidime-avibactam and meropenem with respect to Klebsiella pneumoniae isolates producing different types of carbapenemases and their combinations. K. pneumoniae isolates were collected between 2019 and 2022 from 37 hospitals. PCR was used to screen for bla_KPC-, bla_NDM- and bla_OXA-48-like genes. MICs were determined by the broth microdilution method for meropenem, aztreonam-avibactam and ceftazidime-avibactam at a constant avibactam concentration of 4 mg l^-1. MIC distributions were analyzed for groups of isolates based on the identified carbapenemases including their combinations. The AZT/AVI MIC₅₀ and MIC₉₀ for all NDM-positive isolates were 0.25 and 0.5, respectively, and for serine-carbapenemase-only producers, they were 0.25 and 1 mg l^-1, respectively. The CZD/AVI MIC₅₀ and MIC₉₀ values for serine-carbapenemase-only producers were 1 and 4 mg l^-1, respectively. The AZT/AVI MIC₅₀ and MIC₉₀ values for co-producers and single carbapenemase producers were the same (i.e., 0.25 and 1 mg l^-1, respectively). The total proportion of meropenem-susceptible isolates (≤8 mg l^-1) among all the carbapenemase producers was 25.1% (31.1% among single-carbapenemase producers and 9.2% among co-producers). The results support the use of aztreonam-avibactam for the empirical treatment of infections caused by any carbapenemase producers.

2024-09-21·EXPERT OPINION ON PHARMACOTHERAPY

Aztreonam-avibactam for the treatment of intra-abdominal infections

Review

作者: Gibson, Gabrielle A. ; Delp, Hannah ; Buckman, Sara A.

INTRODUCTION:

Intra-abdominal infections are becoming increasingly common and can lead to significant morbidity and mortality. The incidence of these infections due to resistant gram-negative organisms is also increasing. Given this resistance, new antibiotic combinations are being developed, often utilizing older antibiotics and newer β-lactamase inhibitors. Aztreonam/avibactam (ATM-AVI) is one of the combination antibiotics, which combines aztreonam, a monobactam, with avibactam, a broad-spectrum β-lactamase inhibitor for the treatment of complicated intra-abdominal infections in combination with metronidazole.

AREAS COVERED:

In this drug evaluation manuscript, we provide an overview of intra-abdominal infections and an overview of currently available antimicrobial agents used to treat these infections. ATM-AVI is introduced, including chemistry, pharmacodynamics, pharmacokinetics and clinical studies of this compound.

EXPERT OPINION:

There are limited treatment options for complicated intra-abdominal infections due to resistant gram-negative organisms, especially those with metallo-β-lactamases. One treatment option for these infections is ATM-AVI, which was recently approved in Europe, in addition to metronidazole. These bacteria are difficult to treat, and this new compound is a safe and effective option for empiric treatment in places with a high incidence of infections due to these bacteria, and also treatment for infections when these resistant bacteria are isolated in culture.

项与阿维巴坦钠/氨曲南相关的新闻（医药）

2024-10-08

·BioSpace

Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024

Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases. “Pfizer is at the forefront of vaccine and therapeutic development in respiratory and infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “IDWeek 2024 provides a crucial platform to showcase our innovative advancements and engage with the scientific community, as we work to effectively tackle the ongoing challenge posed by infectious diseases.” “As we approach another respiratory virus season, the importance of preventive vaccines and treatments to help keep us healthy is more apparent than ever,” said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals, Pfizer. “We’re excited to present new, meaningful data that we hope will help further inform healthcare providers.” Pfizer will present research from its robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections. Details for Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (PDT) Location ORAL & LATE-BREAKING PRESENTATIONS 580 - Pharmacokinetics (PK) and Safety of Nirmatrelvir/Ritonavir (NMV/r) in Non-Hospitalized Symptomatic Pediatric Patients Ages 6 Years and Older with COVID-19 Who Are at Increased Risk of Progression to Severe Disease (EPIC-Peds) Jacqueline Gerhart, PhD Oct 19 2:45 – 2:57 PM US PT 403 A 88 - Efficacy of Nirmatrelvir/Ritonavir in High-Risk Trial Participants With Prior SARS-CoV-2 Infection or Vaccination: A Pooled Analysis John M. McLaughlin, PhD Oct 17 10:42 – 10:54 AM US PT 411 165 - Real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related severe acute respiratory infection (ARI) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC), November 2023-April 2024 Sara Tartof, PhD, MPH, (KPSC)* Oct 17 1:45 – 3:00 PM US PT 403A 571 – Safety and Immunogenicity of Coadministered Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine With and Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age Rahsan Erdem, MD Oct 19 1:45 – 2:03 PM US PT 408 A POSTER PRESENTATIONS COVID-19 P - 1194 - Comparison of COVID-19 Inpatient Burden in Hospitalized Children Age < 5years, by SARS-CoV-2 Variant Kathleen M. Andersen, PhD MSc Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1906 - Early COVID-19 and Severity of Subsequent Omicron Infection in Ontario, Canada Caroline Kassee, MPH (Sinai Health)* Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 1977 - Six-Month Trajectory of Symptoms of COVID-19 Fatigue by Age and BNT162b2 COVID-19 Vaccination Status: A Prospective Study Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2047 - Public Health Impact and Economic Value of an Additional Dose of Pfizer-BioNTech XBB.1.5-adapted COVID-19 Vaccine for Older Adults in the United States Alon Yehoshua, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2048 - COVID-19 XBB.1.5 vaccine uptake based on state vaccine registries compared to national survey data Angela Cook, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2054 - Effectiveness of a Single COVID-19 mRNA Vaccine Dose in Individuals Previously Infected with SARS-CoV-2: A Systematic Review Hannah R. Volkman, PhD, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2060 - Effectiveness of BNT162b2 COVID-19 Vaccination Against Long COVID Among Older Adults: A Nationwide Study Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2062 - COVID-19 XBB.1.5-adapted vaccine uptake in immunocompromised individuals using tokenized state vaccine registries Matthew A. Brouillette, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2017 - Patient Reported Outcomes of Nirmatrelvir/Ritonavir Treatment for High-risk, Nonhospitalized Adults with Symptomatic COVID-19 Ashley S. Cha-Silva, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K Lyme Disease P - 599 - 6-Valent, OspA-Based VLA15 Lyme Disease Vaccine Candidate Against Lyme Borreliosis in a Healthy Pediatric and Adult Study Population: A Phase 2 Study Update James H. Stark, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1287 - Incidence of Symptomatic Lyme Borreliosis in Nine European Countries, 2018−2022 Frederick Angulo, DVM PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1291 - Racial disparities in Lyme disease among beneficiaries of US Medicaid and Medicare L. Hannah Gould, PhD, MS, MBA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1293 - Healthcare Costs Associated with Lyme Disease in a U.S. Insured Population Holly Yu, MSPH Oct 18 12:15 – 1:30 PM US PT Hall J & K Meningococcal Disease P - 1299 - Epidemiology of Invasive Meningococcal Disease in the United States: Review of Recent Data and Identified Risk Factors Jessica Presa, MD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1304 - Public Health Impact of changes to Meningococcal vaccination platform in the United States Katharina Schley, Dr. rer pol. Oct 18 12:15 – 1:30 PM US PT Hall J & K Pneumococcal disease P - 8 - Assessment of 13-valent pneumococcal conjugate vaccine effectiveness among people living with HIV in the United States Amanda C. Miles, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 628 - Real-world impact of pneumococcal conjugate vaccines on vaccine serotypes and cross-reacting non-vaccine serotypes Kevin Apodaca, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 629 - The health and economic impact of the PCV15 and PCV20 priming series during the first year of life in the US Mark Rozenbaum, PhD, M.B.A Oct 17 12:15 – 1:30 PM US PT Hall J & K Respiratory Syncytial Virus (RSV) P - 673 - Respiratory Syncytial Virus (RSV) Hospitalizations During Off-Season Months Among Infants in US Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 674 - The Economic Burden of Infant RSV Among US Caregivers Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 40 - Impact of case and control selection on influenza vaccine effectiveness (VE) among adults aged 40 years and older hospitalized with acute respiratory illness (ARI) during 2022-2023 using a test negative design (TND): secondary analysis of the North America Multi-Specimen Study Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1204 - Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1205 - Impact of the COVID-19 Pandemic on Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 677 - Estimation of Respiratory Syncytial Virus-Attributable Hospitalizations Among Older Adults in Japan between 2015 and 2018: An Administrative Health Claims Database Analysis Asuka Yoshida, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 680 - Estimated Respiratory Syncytial Virus (RSV)-Related Hospitalizations and Deaths Among Adults in Norway between 2010–2019 Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 682 - The Risk of Cardiorespiratory Events for Up to 180 days Following Respiratory Syncytial Virus (RSV) Infection Hospitalization: A Self-Controlled Case Series Analysis Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P – 683 – Estimation of RSV-Attributable Cardiovascular and Respiratory Hospitalizations in Adults in Germany, Between 2015-2019 Caroline Beese Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 604 - Preliminary real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related lower respiratory tract disease (LRTD) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC) November 2023-April 2024 Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 53 - Trends in Co-administration of Adult Vaccinations in the US Retail Pharmacy Setting Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 603 - Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of RSV Among Older Adults in the United States Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 600 - Efficacy Of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season John Woodside, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 596 - Immunobridging Demonstrating Effectiveness of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults 18-59 Years of Age at High Risk of Severe RSV Disease in a Phase 3 Trial: The C3671023 MONeT Study Results Elliot N. DeHaan, MD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 681 - Estimated Incidence of Respiratory Syncytial Virus (RSV)-Related Hospitalizations for Acute Respiratory Infections (ARIs), including Community Acquired Pneumonia (CAP), in Adults in Germany Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 605 - Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High and Durable Neutralizing Titers Across an Entire RSV Season Among Older Adults Tarek Mikati, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 595 - Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes Daniel Eiras, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 21 - Comparison of Three RSV Vaccine Lower Respiratory Tract Disease Primary Endpoint Definitions for Adult Vaccine Sarah E. Williams, MD. MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 2357 - Respiratory Syncytial Virus (RSV) Disease Burden Among Adults in Primary Care Settings in High-Income Countries: A Systematic Review and Modelling Study You Li; multiple Pfizer co-authors Oct 19 12:15 – 1:30 PM US PT Hall J & K Aztreonam-Avibactam P - 105 - Aztreonam-Avibactam Compared with Adjunctive Colistin Combined with Meropenem for the Treatment of Serious Gram-Negative Bacterial Infections: Subgroup Analysis of the Phase 3 REVISIT Study Heidi Leister-Tebbe, BSN Oct 17 12:15-1:30 PM US PT Hall J & K P - 1080 Aztreonam-Avibactam Activity Against Gram-negative Bacteria Isolated From Patients with Pneumonia from Europe, Asia, and Latin America (2021–2023) Helio S. Sader, MD, PhD, FIDSA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1256 - Pharmacokinetic/Pharmacodynamic (PK/PD) Target Attainment Analyses for Aztreonam-Avibactam Dosing Regimens Susan Raber*, PharmD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1508 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program From 2018-2022 Mark Estabrook*, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1509 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolated From Pediatric and Adult Patients Collected During the ATLAS Global Surveillance Program, 2018-2022 Mark Estabrook*, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K Isavuconazole P - 1168 - Activity of Isavuconazole and Comparator Agents Against Pediatric Fungal Isolates Collected from 2017–2023 in a Global Surveillance Program Marisa Winkler, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K Ceftazidime-Avibactam P- 1506 - In Vitro Activity of Ceftazidime-Avibactam and Comparator Agents Against Pseudomonas aeruginosa Collected from Patients with Presumed Hospital- and Community-Acquired Respiratory Tract Infections as a Part of the ATLAS Global Surveillance Program 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P- 1507 - In Vitro Activity of Ceftazidime-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program from 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K * =multiple Pfizer co-authors Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO ® (Respiratory Syncytial Virus Vaccine) or visit and . Please see full Prescribing Information for COMIRNATY ® (COVID-19 Vaccine, mRNA) or visit . Please see full Prescribing Information for CRESEMBA ® (Isavuconazonium Sulfate) or visit Please see full Prescribing Information for PAXLOVID TM (Nirmatrelvir and Ritonavir) or visit . Please see full Prescribing Information for PREVNAR 20 TM (Pneumococcal 20-valent Conjugate Vaccine) or visit . Please see full Prescribing Information for PREVNAR 13 ® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for ZAFICEFTA ® (Ceftazidime-Avibactam). About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer . DISCLOSURE NOTICE: The information contained in this release is as of October 8, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Contacts Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

疫苗临床3期临床2期临床结果

2024-05-23

·美通社

Access to Medicine Foundation的新报告显示，制药公司可以采取哪些措施来确保处于耐药性前线的患者能够获得正在开发的少数有前途的抗微生物药物

阿姆斯特丹 2024年5月23日 /美通社/ -- 开发替代抗生素和抗真菌药物来对抗超级细菌的竞赛严重不足，使世界各地的人们处于危险之中。但是，研发（R&D）的转变，包括对准入和管理规划的投资，可以对抗微生物药物耐药性（AMR）产生重大影响。由于大多数以研究为基础的大型制药公司不再活跃于抗微生物药物研发，因此上市的新疗法很少，这使得患者容易受到抗微生物药物耐药性快速传播的影响。尽管存在这种现实，但少数处于后期临床开发阶段的项目可能会产生重大影响。 A ccess to Medicine Foundation的新报告追踪了葛兰素史克、F2G、Innoviva、Venatorx（分别为gepotidacin、olorofim、zoliflodacin和cefepime-taniborbactam）和辉瑞最近批准的阿曲南阿维巴坦（Emblaveo®）管道中的五个此类项目。通过提供急需的药物来治疗耐药性淋病、尿路感染、腹腔内感染、呼吸道感染和侵入性真菌感染，这些项目每年总共可以挽救至少16万人的生命。尽管这些疾病影响着全球范围广泛的患者，但妇女和儿童，尤其是生活在低收入和中等收入国家（LMIC）的妇女和儿童，受到的影响尤其严重。 "在抗击耐药感染的竞赛中，我们的武器规模虽小但有效。我们在这场竞赛中获胜与失败的区别取决于公司如何为生活在耐药前线的人们提供机会。" — 医学准入基金会首席执行官贾亚斯里•艾耶。调查结果显示，各公司在其准入和管理计划中采用了多种策略，但结构化的预先计划尚未成为标准。令人鼓舞的是，在范围内的五家公司中，有四家——葛兰素史克、辉瑞、Innoviva和Venatorx——正在进行或启动直接针对儿童的临床试验，这表明在缩小成人和儿科准入差距方面取得了进展。五个低收入国家确定了注册承诺：中国、印度、墨西哥、南非和泰国。但是，对于范围内的113个中低收入国家中的108个，人们也面临着这些项目针对的疾病的沉重负担，目前尚不清楚在初步批准后是否会提供这些项目。该报告为重点公司确定了机遇和建议，并概述了全球利益相关者在抗微生物药物研发领域的可行措施，以促进广泛采用预先准入和管理规划。 "应对耐药性的巨大规模和速度是一个复杂的全球健康问题，需要制药公司在多个领域采取行动。这包括提供适当的准入和实施管理措施，以保障创新抗微生物药物的有效性。不这样做将限制解决耐药性的努力。"——准入医学基金会运营与研究总监玛丽恩•维尔霍夫。在全球卫生利益相关者为2024年联合国大会抗菌素耐药性高级别会议做准备之际，本报告是在关键时刻发布的，强调了需要注意的紧迫差距。在这里阅读报告。

微生物疗法临床研究

2024-05-23

·Outsourcing Pharma

What can pharma companies do to get promising antimicrobials to the frontlines of drug resistance?

According to the report, the race to create antibiotics and antifungals to conquer superbugs is falling perilously short, which the authors say is putting people across the world at risk. However, a shift in research and development (R&D), including investment in access and stewardship planning, can make a significant impact against antimicrobial resistance (AMR). As most large research-based pharmaceutical companies are no longer active in antimicrobial research and development (R&D), there are very few new treatments making it to market, leaving patients vulnerable to the rapid spread of AMR. Despite this reality, a handful of projects in late-stage clinical development could have a significant impact. Difficult-to-treat invasive, rare fungal mold infections The foundation is tracking five drugs which include gepotidacin, a small molecule commercialized by GSK with a leading phase 3 program in urinary tract infections and F2G’s olorofim, a first of the new orotomide class of antifungals in development for the treatment of difficult-to-treat invasive, rare fungal mold infections. Innoviva’s zoliflodacin is another treatment being tracked and is said to be one of the most promising new treatments for gonorrhoeae currently in phase 3 clinical trials. According to a report in Nature Scientific Reports, studies have found very little resistance to the drug currently circulating in strains, and in-vitro experiments demonstrated that it is difficult to induce resistance. Venatorx’s cefepime-taniborbactam is also under the foundation’s radar. The beta-lactam/beta-lactamase inhibitor (BL/BLI) combination antibiotic is being developed for the treatment of complicated urinary tract infections and hospital acquired bacterial pneumonia. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Pfizer's recently approved aztreonam-avibactam (Emblaveo) is the first β-lactam/β-lactamase inhibitor antibiotic combination approved in the European Union for treating serious infections in adult patients caused by multidrug-resistant gram-negative bacteria, including metallo-β-lactamase-producing bacteria. Emblaveo was reviewed under European Medicines Agency accelerated assessment procedure, used when a pharmaceutical product is of major interest for public health and therapeutic innovation. People living on the frontlines of drug resistance Collectively, these projects could save at least 160,000 lives annually by providing much-needed medicines to treat drug-resistant gonorrhoea, urinary tract infections, intra-abdominal infections, respiratory infections, and invasive fungal infections. While these diseases affect a wide range of patients globally, women and children- especially those living in low-and middle-income countries (LMICs)- are disproportionately affected. Jayasree Iyer, CEO, at the Access to Medicine Foundation, said: “We have a small, but effective, arsenal in the race to combat drug-resistant infections. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance.” The foundation said that findings reveal that companies are employing diverse range of strategies within their access and stewardship plans but structured advance planning has not yet become standard. Encouragingly, it said, four of the five companies in scope, GSK, Pfizer, Innoviva, and Venatorx, are conducting or initiating clinical trials that directly target children, signalling progress in closing the gap between adult and paediatric access. Tackling the sheer scale and pace of drug resistance Commitments for registration were identified in five LMICs: China, India, Mexico, South Africa, and Thailand. However, for 108 of 113 LMICs in scope, where people also face high burdens of the diseases targeted by these projects, it is currently unclear whether any of them will be made available upon initial approval. The report identifies opportunities and recommendations for companies in focus and outlines actionable steps for global stakeholders in antimicrobial R&D to promote widespread adoption of advance access and stewardship planning. Marijn Verhoef, director of operations and research, at the Access to Medicine Foundation, said: “Tackling the sheer scale and pace of drug resistance is a complex global health issue that will require action from pharmaceutical companies across several areas. This includes providing appropriate access and implementing stewardship measures to safeguard the effectiveness of innovative antimicrobials. Failure to do this will limit efforts to tackle drug resistance.” The foundation added that as global health stakeholders prepare for 2024 UN General Assembly's High-level Meeting on AMR, this report comes at a crucial moment, emphasising the urgent gaps that need attention.

临床3期上市批准

100 项与阿维巴坦钠/氨曲南相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复杂腹腔感染	欧盟	Pfizer Inc.	2024-04-22
复杂腹腔感染	冰岛	Pfizer Inc.	2024-04-22
复杂腹腔感染	列支敦士登	Pfizer Inc.	2024-04-22
复杂腹腔感染	挪威	Pfizer Inc.	2024-04-22
复杂的尿路感染	欧盟	Pfizer Inc.	2024-04-22
复杂的尿路感染	冰岛	Pfizer Inc.	2024-04-22
复杂的尿路感染	列支敦士登	Pfizer Inc.	2024-04-22
复杂的尿路感染	挪威	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	欧盟	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	冰岛	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	列支敦士登	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	挪威	Pfizer Inc.	2024-04-22
医院获得性肺炎	欧盟	Pfizer Inc.	2024-04-22
医院获得性肺炎	冰岛	Pfizer Inc.	2024-04-22
医院获得性肺炎	列支敦士登	Pfizer Inc.	2024-04-22
医院获得性肺炎	挪威	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	欧盟	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	冰岛	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	列支敦士登	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	挪威	Pfizer Inc.	2024-04-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
腹腔感染	临床2期	美国	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	中国	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	捷克	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	希腊	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	匈牙利	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	印度	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	西班牙	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	中国台湾	Pfizer Inc.	2023-04-18
腹腔感染	临床2期	土耳其	Pfizer Inc.	2023-04-18
细菌感染	临床1期	英国	Pfizer Inc.	2012-09-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03329092 (REVISIT, Pubmed \| Lancet Infect Dis)	临床3期	革兰氏阴性菌感染 Gram-negative bacteria	422	Aztreonam-avibactam	繭醖憲憲憲窪衊壓願願(簾獵選衊築網構築築顧) = 鏇鹹艱窪鏇夢獵範憲鏇選願糧選壓積憲鏇觸獵 (鏇艱積築蓋築襯獵襯鏇 ) 更多	积极	2024-10-01
				Meropenem	繭醖憲憲憲窪衊壓願願(簾獵選衊築網構築築顧) = 構鑰艱鬱醖襯顧製網襯選願糧選壓積憲鏇觸獵 (鏇艱積築蓋築襯獵襯鏇 ) 更多
NCT03329092 (REVISIT, CTgov)	临床3期	革兰氏阴性菌感染 \| 复杂腹腔感染 \| 呼吸机相关性肺炎 ... 更多	422	MTZ+ATM-AVI	鹽齋鏇網襯憲廠膚築鏇(襯觸襯夢壓遞鏇夢鬱鏇) = 廠窪顧廠選獵築蓋鹹願鹹廠齋網選淵糧憲夢積 (膚醖範鬱顧鹽製壓築淵, 糧窪積鹽範範壓獵繭鑰 ~ 蓋鏇積鏇網積醖餘襯鑰) 更多	-	2024-05-07
NCT03580044 (CTgov)	临床3期	细菌感染	15	Avibactam (ATM- AVI+Aztreonam (Aztreonam- Avibactam (ATM- AVI))	願糧餘鬱襯顧夢鹽鏇糧(憲糧淵壓獵獵鬱鏇範壓) = 窪艱蓋製鏇顧齋衊艱壓餘築範獵餘願蓋膚衊襯 (鹹鬱築餘淵範網膚淵獵, 襯膚襯廠鬱積襯鬱獵鬱 ~ 廠繭鬱範淵蓋艱範選構) 更多	-	2024-02-02
				metronidazole (Best Available Therapy (BAT))	願糧餘鬱襯顧夢鹽鏇糧(憲糧淵壓獵獵鬱鏇範壓) = 膚憲選獵淵鏇簾衊鹽廠餘築範獵餘願蓋膚衊襯 (鹹鬱築餘淵範網膚淵獵, 積膚網構衊艱顧鹽鹽鏇 ~ 壓範窪繭繭製範鬱繭選) 更多
NCT04973826 (CTgov)	临床1期	-	12	AVIBACTAM (ATM-AVI+AZTREONAM	製遞淵鹹網餘醖鬱繭網(鑰夢積顧築鏇艱餘觸糧) = 齋膚築築夢顧蓋衊鬱齋壓鹹範願衊鑰糧襯鹽範 (艱鏇衊淵憲淵餘壓範衊, 壓憲夢製築淵願鏇憲憲 ~ 淵淵鬱膚衊願淵製夢鏇) 更多	-	2023-07-28
NCT04486625 (CTgov)	临床1期	肾功能不全	11	ATM (Cohort 1: Normal Renal Function)	繭範膚築範糧積願遞膚(鹹蓋願築築願夢餘艱鹽) = 築觸構壓繭鬱艱廠鹽遞鹽餘艱範醖膚構選築齋 (積範衊獵積憲衊糧製淵, 艱網構廠積鹽獵鏇觸簾 ~ 網醖憲顧遞襯選繭積顧) 更多	-	2023-07-28
				ATM (Cohort 2: Severe Renal Impairment)	繭範膚築範糧積願遞膚(鹹蓋願築築願夢餘艱鹽) = 繭壓憲餘鹹願遞顧餘壓鹽餘艱範醖膚構選築齋 (積範衊獵積憲衊糧製淵, 構壓築蓋獵觸壓選襯齋 ~ 遞鏇繭鹽蓋製獵繭構觸) 更多
NCT02655419 (Pubmed \| BMJ Open)	临床2期	复杂腹腔感染	40	aztreonam-avibactam (Hospitals 3 and 6)	製襯鬱蓋壓製鏇醖製繭(顧廠築築衊遞願壓壓積) = 膚膚製齋顧鬱範構繭糧鏇願遞膚鹹獵淵觸鏇範 (顧鬱鹽選積鬱範構構積 )	-	2022-02-03
NCT02655419 (CTgov)	临床2期	复杂腹腔感染	40	AVI+Metronidazole (ATM-AVI+ Metronidazole:Low AVI Dose Cohort)	鹹築鹹襯觸願襯蓋壓觸(構醖淵顧鏇蓋艱膚廠憲) = 簾鏇願選網簾膚觸蓋觸艱壓窪齋鹹憲網淵夢簾 (憲網觸鹹範選構艱廠醖, 製鏇繭衊艱觸範繭製鹹 ~ 獵窪衊遞廠顧鑰鏇醖遞) 更多	-	2019-03-04
				AVI+Metronidazole (ATM-AVI + Metronidazole: High AVI Dose Cohort)	糧繭繭醖齋夢觸觸鬱獵(壓憲窪餘襯窪簾觸窪構) = 齋鬱獵獵範觸壓繭廠鹽願築鏇獵積齋夢廠糧獵 (襯醖襯願淵壓醖蓋積膚, 選窪築觸觸醖獵窪觸糧 ~ 蓋顧壓網範選壓齋觸鏇) 更多