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

NCT ID: NCT03409679

Last Updated: 2019-08-28

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2019-07-17

Brief Summary

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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.

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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

NONE

Study Groups

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Murepavadin

Murepavadin IV + one anti-pseudomonal antibiotic

Group Type EXPERIMENTAL

Murepavadin

Intervention Type DRUG

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

Two anti-pseudomonal antibiotics

Association of 2 anti-pseudomonal antibiotics

Group Type ACTIVE_COMPARATOR

Two anti-pseudomonal antibiotics

Intervention Type DRUG

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

Interventions

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Murepavadin

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

Intervention Type DRUG

Two anti-pseudomonal antibiotics

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

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
* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Polyphor Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research site

Chicago, Illinois, United States

Site Status

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Springfield, Missouri, United States

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Greensboro, North Carolina, United States

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Research Site 1

Belo Horizonte, , Brazil

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Research Site 2

Belo Horizonte, , Brazil

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Itaquaquecetuba, , Brazil

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Porto Alegre, , Brazil

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São José do Rio Preto, , Brazil

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Zagreb, , Croatia

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Research site 2

Zagreb, , Croatia

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Tallinn, , Estonia

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Tartu, , Estonia

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Võru, , Estonia

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Lille, , France

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Limoges, , France

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Lyon, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pierre-Bénite, , France

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Athens, , Greece

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Ioannina, , Greece

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Larissa, , Greece

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Larissa, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Budapest, BU, Hungary

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Budapest, BU, Hungary

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Ózd, BZ, Hungary

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Kistarcsa, , Hungary

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Székesfehérvár, , Hungary

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Vác, , Hungary

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Jerusalem, JM, Israel

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Nahariya, Z, Israel

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Tiberias, Z, Israel

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Petah Tikva, , Israel

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Safed, , Israel

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Tel Litwinsky, , Israel

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Research Site 1

Guadalajara, , Mexico

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Research Site 2

Guadalajara, , Mexico

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Monterrey, , Mexico

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Pretoria, Gauteng, South Africa

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Cape Town, , South Africa

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Pretoria, , South Africa

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Pretoria, , South Africa

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Ansansi Danweongu, , South Korea

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Gangwon-do, , South Korea

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Gyeongsang, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Research Site 3

Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, B, Spain

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Terrassa, B, Spain

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Girona, , Spain

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Research Site 1

Bangkok, , Thailand

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Research Site 2

Bangkok, , Thailand

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Khon Kaen, , Thailand

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Research Site

Nonthaburi, , Thailand

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Countries

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

Other Identifiers

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POL7080-011

Identifier Type: -

Identifier Source: org_study_id

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