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
| Registry | NCT03409679, acronym PRISM-MDR |
|---|---|
| Status | Terminated - Safety data review |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 41 (Actual) |
| Sponsor | Polyphor Ltd. (Industry) |
| Conditions | Pneumonia |
| Interventions | Murepavadin, Two anti-pseudomonal antibiotics (Drug) |
| Dates | start 2018-03-23, primary completion 2019-07-17, completion 2019-07-17, first posted 2018-01-24, last updated 2019-08-28 |
| Locations | 61 sites in United States, Brazil, Croatia, Estonia, France, Greece, Hungary, Israel and 5 more countries |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Murepavadin | Experimental | Drug: Murepavadin | Murepavadin IV + one anti-pseudomonal antibiotic |
| Two anti-pseudomonal antibiotics | Active comparator | Drug: Two anti-pseudomonal antibiotics | Association of 2 anti-pseudomonal antibiotics |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Research site | Chicago, Illinois | United States | |
| Research site | Springfield, Missouri | United States | |
| Research site | Greensboro, North Carolina | United States | |
| Research Site 1 | Belo Horizonte | Brazil | |
| Research Site 2 | Belo Horizonte | Brazil | |
| Research Site | Itaquaquecetuba | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | São José do Rio Preto | Brazil | |
| Research site 1 | Zagreb | Croatia | |
| Research site 2 | Zagreb | Croatia | |
| Research site | Tallinn | Estonia | |
| Reasearch site | Tartu | Estonia | |
| Reasearch site | Võru | Estonia | |
| Research site | Lille | France | |
| Reasearch site | Limoges | France | |
| Research site | Lyon | France | |
| Reasearch site | Nice | France | |
| Research site 1 | Paris | France | |
| Research site 2 | Paris | France | |
| Research site 3 | Paris | France | |
| Research site | Pierre-Bénite | France | |
| Research Site | Athens | Greece | |
| Research Site | Ioannina | Greece | |
| Research Site 1 | Larissa | Greece | |
| Research Site 2 | Larissa | Greece | |
| Research Site | Pátrai | Greece | |
| Research Site | Thessaloniki | Greece | |
| Reasearch site | Budapest, BU | Hungary | |
| Research site | Budapest, BU | Hungary | |
| Reasearch site | Ózd, BZ | Hungary | |
| Research Site | Kistarcsa | Hungary | |
| Research Site | Székesfehérvár | Hungary | |
| Research Site | Vác | Hungary | |
| Research site | Jerusalem, JM | Israel | |
| Research site | Nahariya, Z | Israel | |
| Research site | Tiberias, Z | Israel | |
| Research site | Petah Tikva | Israel | |
| Research site | Safed | Israel | |
| Research site | Tel Litwinsky | Israel | |
| Research Site 1 | Guadalajara | Mexico | |
| Research Site 2 | Guadalajara | Mexico | |
| Research Site | Monterrey | Mexico | |
| Research site 1 | Pretoria, Gauteng | South Africa | |
| Research Site | Cape Town | South Africa | |
| Research Site 2 | Pretoria | South Africa | |
| Research Site | Pretoria | South Africa | |
| Research Site | Ansansi Danweongu | South Korea | |
| Research Site | Gangwon-do | South Korea | |
| Research site | Gyeongsang | South Korea | |
| Research site | Incheon | South Korea | |
| Research site 1 | Seoul | South Korea | |
| Research site 2 | Seoul | South Korea | |
| Research Site 3 | Seoul | South Korea | |
| Research site | Seoul | South Korea | |
| Research site | Barcelona, B | Spain | |
| Research site | Terrassa, B | Spain | |
| Research site | Girona | Spain | |
| Research Site 1 | Bangkok | Thailand | |
| Research Site 2 | Bangkok | Thailand | |
| Research Site | Khon Kaen | Thailand | |
| Research Site | Nonthaburi | Thailand |