Clinical trial NCT03582007: Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: All cause mortality rates
timeFrame: 28 days after start of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Research site
state: Iowa
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Břeclav
country: Czechia
facility: Research site
city: Kolín
country: Czechia
facility: Research site
city: Argenteuil
country: France
facility: Research site
city: Hadera
country: Israel
facility: Research site
city: Tel Aviv
country: Israel
facility: Research site
Study officials:
References: