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Phase 1, Non-comparative, Open-Label Study of Pharmacokinetics and Safety of a Single-Dose of ZTI-01 (Fosfomycin for Injection) in Pediatric Subjects (<12 Years of Age)

Phase 1 study, a single dose of ZTI-01 given to pediatric subjects (under 12 years of age) who require antibiotic therapy to see what the body does to the drug (pharmacokinetics) and to compare if these effects are similar to those observed in adults at a 6g ZTI-01 dose. Study will help establish pediatric dosing in younger children by age cohort. This is a multiple-center, open-label, PK study of ZTI-01 (fosfomycin for injection) single dose scaled by allometric weight-modeling from an adult ZTI-01 dose of 6 grams. Eligible subjects must be receiving standard of care antibiotics for proven or suspected bacterial infection or for peri-operative prophylaxis surgery (in or out of hospital).

开始日期2018-05-24

申办/合作机构

Nabriva Therapeutics AG

NCT03709927 / Completed临床1期

A Phase 1, Randomized, Blinded, Placebo and Moxifloxacin Controlled, 4-Period Crossover, Study Evaluating the Effect of ZTI-01 on 12-Lead Electrocardiogram Parameters in Healthy Adult Subject

The purpose of this study is to evaluate if ZTI-01 (fosfomycin for injection), an investigational drug being developed to treat people with complicated urinary tract and kidney infections, has any effect on the electrical activity of the heart.

开始日期2018-01-11

申办/合作机构

Nabriva Therapeutics AG

PER-029-16 / Completed临床3期

A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC-3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia

开始日期2017-02-11

申办/合作机构

Nabriva Therapeutics AG

100 项与 Nabriva Therapeutics AG 相关的临床结果

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0 项与 Nabriva Therapeutics AG 相关的专利（医药）

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3

项与 Nabriva Therapeutics AG 相关的文献（医药）

2017-01-01·Open Forum Infectious Diseases

Efficacy of Lefamulin Against Staphylococcus aureus-Induced Bacteremia in a Neutropenic and Immunocompetent Murine Model

作者: Evelin Fischer ; Wolfgang W Wicha ; Barbara C Kappes

2012-01-01·Drug Discovery

Chapter 15. Retapamulin: a First-in-Class Pleuromutilin Antibiotic

作者: Novak, Rodger

A review.Retapamulin is a first-in-class topical pleuromutilin which, although probably perfectly suited to treat uncomplicated skin and skin structure infections (SSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA), has failed so far to provide sufficient evidence justifying the inclusion of MRSA on its label.It seems that the low prevalence of MRSA in secondarily infected traumatic lesions (SITL) and impetigo as well as possibly some aspects of clin. trial design have led to this mishap.Nevertheless, given the novel mode of action, low potential for cross-resistance and low propensity of developing resistance, in combination with the overall high efficacy demonstrated in clin. trials, retapamulin should be considered as a valuable new option for the management of SITL and impetigo.An overview of the indications and usage of retapamulin is given and some clin. data provided so far for retapamulin are summarized.

Current Opinion in Investigational Drugs (BioMed Central)

The pleuromutilin antibiotics: a new class for human use

作者: Shlaes, David M. ; Novak, Rodger

A review.Pleuromutilins were discovered as natural-product antibiotics in 1950.Tiamulin was the first pleuromutilin compound to be approved for veterinary use in 1979, followed by valnemulin in 1999.It was not until 2007 that retapamulin became the first pleuromutilin approved for use in humans.However, retapamulin is limited to topical application.Recent advances in lead optimization have led to the synthesis of pleuromutilins that combine potent antibacterial activity with favorable pharmaceutical properties, making these compounds suitable for oral and i.v. delivery.Most pleuromutilins have an antibacterial spectrum that spans the common pathogens involved in both skin and respiratory tract infections.Two new pleuromutilins, BC-3205 and BC-7013 (both Nabriva Therapeutics AG), have entered clin. trials.In this review, the key properties of pleuromutilin derivatives, designed primarily through modifications at the C(14) side chain, are presented, and the potential of these compounds in systemic therapy in humans is discussed.

100 项与 Nabriva Therapeutics AG 相关的药物交易

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100 项与 Nabriva Therapeutics AG 相关的转化医学

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