Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03409679

Acronym

PRISM-MDR

Enrollment

Registered

2018-01-24

Start date

2018-03-23

Completion date

2019-07-17

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Brief summary

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.

Interventions

DRUGMurepavadin

Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)

DRUGTwo anti-pseudomonal antibiotics

Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Subject has received mechanical ventilation for at least 48h at the time of the randomisation * Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization * Presence of new or progressive infiltrate on chest X-ray * Presence of clinical criteria consistent with VABP * High probability of VABP caused by Pseudomonas aeriginosa Key

Exclusion criteria

* Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia * Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction * Severe liver or renal impairment * Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control

Design outcomes

Primary

Measure	Time frame
Clinical cure rate	21-24 days after start of study treatment

Countries

Brazil, Croatia, Estonia, France, Greece, Hungary, Israel, Mexico, South Africa, South Korea, Spain, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026