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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2019-07-17

Brief Summary

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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

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Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Sponsor blinded

Study Groups

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Murepavadin

Murepavadin + ertapenem

Group Type EXPERIMENTAL

Murepavadin

Intervention Type DRUG

Murepavadin + ertapenem

Anti-pseudomonal antibiotic

One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)

Group Type ACTIVE_COMPARATOR

One anti-pseudomonal antibiotic

Intervention Type DRUG

Either meropenem or piperacillin-tazobactam

Interventions

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Murepavadin

Murepavadin + ertapenem

Intervention Type DRUG

One anti-pseudomonal antibiotic

Either meropenem or piperacillin-tazobactam

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No