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TerminatedNCT03409679PRISM-MDRUpdated Aug 28, 2019

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

A Phase 3 interventional study of Murepavadin and Two anti-pseudomonal antibiotics in Pneumonia, sponsored by Polyphor Ltd.. Terminated at 61 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Polyphor Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
Safety data review
Phase
Phase 3
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Pneumonia

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Murepavadin

    Murepavadin IV + one anti-pseudomonal antibiotic

    Drug: Murepavadin

  • Active comparator
    Two anti-pseudomonal antibiotics

    Association of 2 anti-pseudomonal antibiotics

    Drug: Two anti-pseudomonal antibiotics

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

05

What researchers measure

Primary outcomes

  1. Clinical cure rate

    Time frame: 21-24 days after start of study treatment

06

Study locations

61 sites
  • Research site
    Chicago, Illinois 60208, United States
  • Research site
    Springfield, Missouri 65802, United States
  • Research site
    Greensboro, North Carolina 27403, 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
    Ioánnina, Greece
  • Research Site 1
    Larissa, Greece
  • Research Site 2
    Larissa, Greece
  • Research Site
    Patra, Greece
  • Research Site
    Thessaloníki, Greece
  • Reasearch site
    Budapest, BU, Hungary
  • Research site
    Budapest, BU, Hungary
  • Reasearch site
    Ózd, BZ, Hungary
  • Research Site
    Kistarcsa, Hungary
  • Research Site
    Szekesfehervar, Hungary
  • Research Site
    Vác, Hungary
  • Research site
    Jerusalem, JM, Israel
  • Research site
    Nahariya, Z, Israel
  • Research site
    Tiberias, Z, Israel
  • Research site
    Petah Tiqva, Israel
  • Research site
    Tel HaShomer, Israel
  • Research site
    Zefat, Israel
  • Research Site
    Ansansi Danweongu, Korea, Republic of
  • Research Site
    Gangwon-do, Korea, Republic of
  • Research site
    Gyeongsang, Korea, Republic of
  • Research site
    Incheon, Korea, Republic of
  • Research site 1
    Seoul, Korea, Republic of
  • Research site 2
    Seoul, Korea, Republic of
  • Research Site 3
    Seoul, Korea, Republic of
  • Research site
    Seoul, Korea, Republic of
  • Research Site 1
    Guadalajara, Mexico
  • Research Site 2
    Guadalajara, Mexico
  • Research Site
    Monterrey, Mexico
  • Research site 1
    Tshwane, Gauteng, South Africa
  • Research Site
    Cape Town, South Africa
  • Research Site
    Pretoria, South Africa
  • Research Site 2
    Tshwane, South Africa
  • 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
07

Registry details

Key details

Study ID
NCT03409679
Lead sponsor
Polyphor Ltd.
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Mar 23, 2018
Primary completion
Jul 17, 2019
Completion
Jul 17, 2019
Last update
Aug 28, 2019

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
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