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

NCT03409679 — Phase 3, Terminated, 41 participants, Polyphor Ltd.

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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

RegistryNCT03409679, acronym PRISM-MDR
StatusTerminated - Safety data review
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment41 (Actual)
SponsorPolyphor Ltd. (Industry)
ConditionsPneumonia
InterventionsMurepavadin, Two anti-pseudomonal antibiotics (Drug)
Datesstart 2018-03-23, primary completion 2019-07-17, completion 2019-07-17, first posted 2018-01-24, last updated 2019-08-28
Locations61 sites in United States, Brazil, Croatia, Estonia, France, Greece, Hungary, Israel and 5 more countries

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
MurepavadinExperimentalDrug: MurepavadinMurepavadin IV + one anti-pseudomonal antibiotic
Two anti-pseudomonal antibioticsActive comparatorDrug: Two anti-pseudomonal antibioticsAssociation of 2 anti-pseudomonal antibiotics
  • Murepavadin (Drug): Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)
  • Two anti-pseudomonal antibiotics (Drug): Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin

+Outcome measures

Primary outcomes

  • Clinical cure rate [21-24 days after start of study treatment]

+Eligibility

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

+Locations (61)

FacilityCityCountryStatus
Research siteChicago, IllinoisUnited States
Research siteSpringfield, MissouriUnited States
Research siteGreensboro, North CarolinaUnited States
Research Site 1Belo HorizonteBrazil
Research Site 2Belo HorizonteBrazil
Research SiteItaquaquecetubaBrazil
Research SitePorto AlegreBrazil
Research SiteSão José do Rio PretoBrazil
Research site 1ZagrebCroatia
Research site 2ZagrebCroatia
Research siteTallinnEstonia
Reasearch siteTartuEstonia
Reasearch siteVõruEstonia
Research siteLilleFrance
Reasearch siteLimogesFrance
Research siteLyonFrance
Reasearch siteNiceFrance
Research site 1ParisFrance
Research site 2ParisFrance
Research site 3ParisFrance
Research sitePierre-BéniteFrance
Research SiteAthensGreece
Research SiteIoanninaGreece
Research Site 1LarissaGreece
Research Site 2LarissaGreece
Research SitePátraiGreece
Research SiteThessalonikiGreece
Reasearch siteBudapest, BUHungary
Research siteBudapest, BUHungary
Reasearch siteÓzd, BZHungary
Research SiteKistarcsaHungary
Research SiteSzékesfehérvárHungary
Research SiteVácHungary
Research siteJerusalem, JMIsrael
Research siteNahariya, ZIsrael
Research siteTiberias, ZIsrael
Research sitePetah TikvaIsrael
Research siteSafedIsrael
Research siteTel LitwinskyIsrael
Research Site 1GuadalajaraMexico
Research Site 2GuadalajaraMexico
Research SiteMonterreyMexico
Research site 1Pretoria, GautengSouth Africa
Research SiteCape TownSouth Africa
Research Site 2PretoriaSouth Africa
Research SitePretoriaSouth Africa
Research SiteAnsansi DanweonguSouth Korea
Research SiteGangwon-doSouth Korea
Research siteGyeongsangSouth Korea
Research siteIncheonSouth Korea
Research site 1SeoulSouth Korea
Research site 2SeoulSouth Korea
Research Site 3SeoulSouth Korea
Research siteSeoulSouth Korea
Research siteBarcelona, BSpain
Research siteTerrassa, BSpain
Research siteGironaSpain
Research Site 1BangkokThailand
Research Site 2BangkokThailand
Research SiteKhon KaenThailand
Research SiteNonthaburiThailand

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