Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas



Status:Recruiting
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:October 22, 2018
End Date:December 2021
Contact:Polyphor Ltd
Email:info@polyphor.com
Phone:+41615671600

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A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled,
parallel group to investigate the efficacy, safety and tolerability of intravenous
murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the
treatment of nosocomial pneumonia in adult subjects


Key Inclusion Criteria:

- Subject has received mechanical ventilation for at least 48h at the time of the
randomisation OR at least 2 of the following signs or symptoms presenting within 24
hours prior to randomization: New onset of cough or worsening of baseline cough and/or
dyspnea, tachypnea and/or hypoxemia and/or new onset of sputum or suctioned
respiratory secretion characterized by purulent appearance indicative of bacterial
infection or a worsening in character of purulent appearance

- Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 25, inclusive, within
24h prior to randomization

- Presence of new or progressive infiltrate on chest X-ray

- Presence of clinical criteria consistent with Pneumonia

- Strong clinical suspicion of pneumonia due to P. aeruginosa

Key Exclusion Criteria:

- Known or suspected community-acquired bacterial pneumonia or viral, fungal, or
parasitic pneumonia

- known hypersensitivity to any component of ertapenem, meropenem or to other drugs in
the same class or demonstrated anaphylactic reactions to beta-lactams or a history of
allergic reactions to any of the penicillins, cephalosporins, or β-lactamase
inhibitors

- Severe liver or renal impairment

- Expected survival < 72 hours

- Evidence from an available surveillance culture of co infection with ertapenem ,
meropenem or piperacillin tazobactam resistant Gram negative pathogen(s)

- Women who are pregnant or nursing
We found this trial at
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