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Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa (PRISM-MDR)

Primary Purpose

Pneumonia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Murepavadin
Two anti-pseudomonal antibiotics
Sponsored by
Polyphor Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Murepavadin

Two anti-pseudomonal antibiotics

Arm Description

Murepavadin IV + one anti-pseudomonal antibiotic

Association of 2 anti-pseudomonal antibiotics

Outcomes

Primary Outcome Measures

Clinical cure rate

Secondary Outcome Measures

Full Information

First Posted
January 8, 2018
Last Updated
August 23, 2019
Sponsor
Polyphor Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03409679
Brief Title
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Acronym
PRISM-MDR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Safety data review
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyphor Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Murepavadin
Arm Type
Experimental
Arm Description
Murepavadin IV + one anti-pseudomonal antibiotic
Arm Title
Two anti-pseudomonal antibiotics
Arm Type
Active Comparator
Arm Description
Association of 2 anti-pseudomonal antibiotics
Intervention Type
Drug
Intervention Name(s)
Murepavadin
Intervention Description
Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)
Intervention Type
Drug
Intervention Name(s)
Two anti-pseudomonal antibiotics
Intervention Description
Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin
Primary Outcome Measure Information:
Title
Clinical cure rate
Time Frame
21-24 days after start of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Research site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Research site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Research site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Research Site 1
City
Belo Horizonte
Country
Brazil
Facility Name
Research Site 2
City
Belo Horizonte
Country
Brazil
Facility Name
Research Site
City
Itaquaquecetuba
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
Country
Brazil
Facility Name
Research Site
City
São José Do Rio Preto
Country
Brazil
Facility Name
Research site 1
City
Zagreb
Country
Croatia
Facility Name
Research site 2
City
Zagreb
Country
Croatia
Facility Name
Research site
City
Tallinn
Country
Estonia
Facility Name
Reasearch site
City
Tartu
Country
Estonia
Facility Name
Reasearch site
City
Võru
Country
Estonia
Facility Name
Research site
City
Lille
Country
France
Facility Name
Reasearch site
City
Limoges
Country
France
Facility Name
Research site
City
Lyon
Country
France
Facility Name
Reasearch site
City
Nice
Country
France
Facility Name
Research site 1
City
Paris
Country
France
Facility Name
Research site 2
City
Paris
Country
France
Facility Name
Research site 3
City
Paris
Country
France
Facility Name
Research site
City
Pierre-Bénite
Country
France
Facility Name
Research Site
City
Athens
Country
Greece
Facility Name
Research Site
City
Ioánnina
Country
Greece
Facility Name
Research Site 1
City
Larissa
Country
Greece
Facility Name
Research Site 2
City
Larissa
Country
Greece
Facility Name
Research Site
City
Patra
Country
Greece
Facility Name
Research Site
City
Thessaloníki
Country
Greece
Facility Name
Reasearch site
City
Budapest
State/Province
BU
Country
Hungary
Facility Name
Research site
City
Budapest
State/Province
BU
Country
Hungary
Facility Name
Reasearch site
City
Ózd
State/Province
BZ
Country
Hungary
Facility Name
Research Site
City
Kistarcsa
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
Country
Hungary
Facility Name
Research Site
City
Vác
Country
Hungary
Facility Name
Research site
City
Jerusalem
State/Province
JM
Country
Israel
Facility Name
Research site
City
Nahariya
State/Province
Z
Country
Israel
Facility Name
Research site
City
Tiberias
State/Province
Z
Country
Israel
Facility Name
Research site
City
Petah Tiqva
Country
Israel
Facility Name
Research site
City
Tel HaShomer
Country
Israel
Facility Name
Research site
City
Zefat
Country
Israel
Facility Name
Research Site
City
Ansansi Danweongu
Country
Korea, Republic of
Facility Name
Research Site
City
Gangwon-do
Country
Korea, Republic of
Facility Name
Research site
City
Gyeongsang
Country
Korea, Republic of
Facility Name
Research site
City
Incheon
Country
Korea, Republic of
Facility Name
Research site 1
City
Seoul
Country
Korea, Republic of
Facility Name
Research site 2
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site 3
City
Seoul
Country
Korea, Republic of
Facility Name
Research site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site 1
City
Guadalajara
Country
Mexico
Facility Name
Research Site 2
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research site 1
City
Tshwane
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site 2
City
Tshwane
Country
South Africa
Facility Name
Research site
City
Barcelona
State/Province
B
Country
Spain
Facility Name
Research site
City
Terrassa
State/Province
B
Country
Spain
Facility Name
Research site
City
Girona
Country
Spain
Facility Name
Research Site 1
City
Bangkok
Country
Thailand
Facility Name
Research Site 2
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
Country
Thailand
Facility Name
Research Site
City
Nonthaburi
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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