Prospective, Non-controlled Pilot Study to Evaluate the Efficacy and Safety of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia

The global pandemic of novel coronavirus disease 2019 (COVID-19) began in Wuhan, China, in December 2019, and has since spread worldwide. The disease is mild in 85% of cases but the remaining 15% requires hospitalization and/or intensive care.
Recent publications show that a significant number of COVID-19 patients are co-infected with one or more pathogens. Most co-infections occurred within 1-4 days of onset of COVID-19 disease and a considerable number of patients arrive to the Emergency rooms with mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin and not severe enough for requiring hospitalization. It therefore seems reasonable to adopt therapeutic strategies for these patients that are effective and easy to follow in the outpatient setting.
Cefditoren (CDN) is a third-generation cephalosporin for oral administration. CDN has a broad spectrum of activity and is particularly active against the bacterial pathogens involved in community respiratory tract infections. Besides that, the use of CDN has been associated with a marked decrease in circulating levels of IL-6 and other pro-inflammatory cytokines and mediators of epithelial damage. The aim of this study is to demonstrate that CDN improves clinical condition in patients with mild-moderate COVID-19 and symptoms of bacterial pneumonia.

开始日期2021-01-05

申办/合作机构

Meiji Pharma Spain SA

NCT03852914 / Unknown statusN/A

Prospective, Multicentre Study to Evaluate the Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients Suffering From Osteoarthritis of the Knee

A Phase III, prospective, multicentre, non-controlled, with consecutive participant enrollment in order to evaluate the efficacy, safety and duration of the effects of the viscosupplementation with a preparation of sodium hyaluronate 2% (SH2%) from Tedec-Meiji Farma S.A. over 12 months. Adult patients diagnosed with primary osteoarthritis of the knee according to American College of Rheumatology (ACR) criteria with radiological grades II and III according to Kellgren-Lawrence scale (KL) will receive a single injection of SH2% and will be followed for 1 year with follow up visits at 6 and 12 months.
At 6 months patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months

开始日期2019-01-17

申办/合作机构

Meiji Pharma Spain SA

[+1]

NCT01893905 / Completed临床3期

Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Sulfate in Combination Versus Placebo in Patients With Osteoarthritis of the Knee

The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.

开始日期2013-06-01

申办/合作机构

Meiji Pharma Spain SA

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2022-12-21·Microbiology Spectrum

Combination of Cefditoren and N -acetyl- l -Cysteine Shows a Synergistic Effect against Multidrug-Resistant Streptococcus pneumoniae Biofilms

Article

作者: Gimeno, Mercedes ; Llamosí, Mirella ; Yuste, Jose ; Coronel, Pilar ; Sempere, Julio ; Domenech, Mirian

2022-10-01·The Lancet Microbe

Effect of pneumococcal conjugate vaccines and SARS-CoV-2 on antimicrobial resistance and the emergence of Streptococcus pneumoniae serotypes with reduced susceptibility in Spain, 2004–20: a national surveillance study

Article

作者: Del Río, Idoia ; Sempere, Julio ; González-Camacho, Fernando ; López Ruiz, Beatriz ; Yuste, Jose ; Llamosí, Mirella ; Domenech, Mirian ; Coronel, Pilar ; Gimeno, Mercedes ; Pérez-García, Covadonga ; Lago, Darío

BACKGROUNDEpidemiological studies are necessary to explore the effect of current pneumococcal conjugate vaccines (PCVs) against antibiotic resistance, including the rise of non-vaccine serotypes that are resistant to antibiotics. Hence, epidemiological changes in the antimicrobial pattern of Streptococcus pneumoniae before and during the first year of the COVID-19 pandemic were studied.METHODSIn this national surveillance study, we characterised the antimicrobial susceptibility to a panel of antibiotics in 3017 pneumococcal clinical isolates with reduced susceptibility to penicillin during 2004-20 in Spain. This study covered the early and late PCV7 periods; the early, middle, and late PCV13 periods; and the first year of the COVID-19 pandemic, to evaluate the contribution of PCVs and the pandemic to the emergence of non-vaccine serotypes associated with antibiotic resistance.FINDINGSSerotypes included in PCV7 and PCV13 showed a decline after the introduction of PCVs in Spain. However, an increase in non-PCV13 serotypes (mainly 11A, 24F, and 23B) that were not susceptible to penicillin promptly appeared. A rise in the proportion of pneumococcal strains with reduced susceptibility to β-lactams and erythromycin was observed in 2020, coinciding with the emergence of SARS-CoV-2. Cefditoren was the β-lactam with the lowest minimum inhibitory concentration (MIC)₅₀ or MIC₉₀ values, and had the highest proportion of susceptible strains throughout 2004-20.INTERPRETATIONThe increase in non-PCV13 serotypes associated with antibiotic resistance is concerning, especially the increase of penicillin resistance linked to serotypes 11A and 24F. The future use of PCVs with an increasingly broad spectrum (such as PCV20, which includes serotype 11A) could reduce the impact of antibiotic resistance for non-PCV13 serotypes. The use of antibiotics to prevent co-infections in patients with COVID-19 might have affected the increased proportion of pneumococcal-resistant strains. Cefotaxime as a parenteral option, and cefditoren as an oral choice, were the antibiotics with the highest activity against non-PCV20 serotypes.FUNDINGThe Spanish Ministry of Science and Innovation and Meiji-Pharma Spain.TRANSLATIONFor the Spanish translation of the abstract see Supplementary Materials section.

2022-03-31·Journal of Antimicrobial Chemotherapy2区 · 医学

A national longitudinal study evaluating the activity of cefditoren and other antibiotics against non-susceptible Streptococcus pneumoniae strains during the period 2004–20 in Spain

2区 · 医学

Article

作者: Llamosí, Mirella ; Sempere, Julio ; Domenech, Mirian ; Del Río, Idoia ; López-Ruiz, Beatriz ; Coronel, Pilar ; Gimeno, Mercedes ; González-Camacho, Fernando ; Yuste, Jose

AbstractBackgroundSurveillance studies including antibiotic resistance and evolution of pneumococcal serotypes are critical to evaluate the susceptibility of commonly used antibiotics and the contribution of conjugate vaccines against resistant strains.ObjectivesTo determine the susceptibility of clinical isolates of Streptococcus pneumoniae with reduced susceptibility to penicillin to a panel of antibiotics during the period 2004–20 and characterize the impact of pneumococcal conjugate vaccines in the evolution of resistant serotypes.MethodsWe selected 3017 clinical isolates in order to determine the minimal inhibitory concentration to penicillin, amoxicillin, cefotaxime, erythromycin, levofloxacin and oral cephalosporins, including cefditoren, cefixime and cefpodoxime.ResultsThe antibiotics with the lowest proportion of resistant strains from 2004 to 2020 were cefditoren (<0.4%), followed by cefotaxime (<5%), penicillin (<6.5%) and levofloxacin (<7%). Among oral cephalosporins, cefixime was the cephalosporin with the highest MIC90 (32 mg/L) and MIC50 (8–16 mg/L) throughout the study, followed by cefpodoxime with highest values of MIC90 (4 mg/L) and MIC50 (2 mg/L) for the majority of the study period. In contrast, cefditoren was the cephalosporin with the lowest MIC90 (1 mg/L) and MIC50 (0.25–0.5 mg/L).ConclusionsCefditoren was the antibiotic with the highest proportion of susceptible strains. Hence, more than 80% of the clinical strains were susceptible to cefditoren throughout the period 2004–20. The proportion of resistant isolates to cefditoren and cefotaxime was scarce, being less than 0.4% for cefditoren and lower than 5% for cefotaxime, despite the increased rates of serotypes not covered by the 13-valent pneumococcal conjugate vaccine.

项与 Meiji Pharma Spain SA 相关的新闻（医药）

2021-01-05

·BioSpace

Meiji Seika Pharma Sets up a New Subsidiary in the US

Jan. 5, 2021 01:00 UTC TOKYO--(BUSINESS WIRE)-- Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi, “Meiji”) today announces the starting of operation of its US subsidiary, Meiji Pharma USA Inc., for expanding activities in the US with its initial focus on facilitating clinical development. Outline of the new company (1) Company name: Meiji Pharma USA Inc. (2) Location: 500 Frank W. Burr Boulevard, Teaneck, NJ 07666 (3) President: Yasushi Miyazawa (4) Scope of business: Clinical research and development (5) Paid in capital: US$100,000. (6) Established: 4 July, 2020 (7) Shareholding structure: Wholly-owned by Meiji Seika Pharma Co., Ltd. Meiji Seika Pharma, since it launched penicillin in Japan in 1946, has been providing high-quality pharmaceutical products such as antibiotics, antidepressants and antipsychotics in Japan and overseas. As a “Speciality & Generic Pharmaceutical Company”, Meiji focuses its pharmaceutical business on infectious disease, central nervous system disorders, and generic drugs as well. (URL: ) Meiji Pharma USA, in collaboration with Meiji, strives for meeting the medical needs and contributes to the well-being of people worldwide. * Integrated Reports: View source version on businesswire.com: Contacts Meiji Pharma USA Inc. Yasushi Miyazawa President Telephone: +1-201-777-7133 E-mail: pr-pharma@meiji.com Source: Meiji Seika Pharma Co., Ltd. View this news release online at:

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