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

Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03409679
• Other study ID #: POL7080-011
• Status: Terminated
• Phase: Phase 3
• Start date: March 23, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: May 2019
• Source: Polyphor Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

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

Locations

Country	Name	City	State
Brazil	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
Croatia	Research site 1	Zagreb
Croatia	Research site 2	Zagreb
Estonia	Research site	Tallinn
Estonia	Reasearch site	Tartu
Estonia	Reasearch site	Võru
France	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
Greece	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
Hungary	Reasearch site	Budapest	BU
Hungary	Research site	Budapest	BU
Hungary	Research Site	Kistarcsa
Hungary	Reasearch site	Ózd	BZ
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Vác
Israel	Research site	Jerusalem	JM
Israel	Research site	Nahariya	Z
Israel	Research site	Petah Tiqva
Israel	Research site	Tel HaShomer
Israel	Research site	Tiberias	Z
Israel	Research site	Zefat
Korea, Republic of	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	Seoul
Korea, Republic of	Research site 1	Seoul
Korea, Republic of	Research site 2	Seoul
Korea, Republic of	Research Site 3	Seoul
Mexico	Research Site 1	Guadalajara
Mexico	Research Site 2	Guadalajara
Mexico	Research Site	Monterrey
South Africa	Research Site	Cape Town
South Africa	Research Site	Pretoria
South Africa	Research site 1	Tshwane	Gauteng
South Africa	Research Site 2	Tshwane
Spain	Research site	Barcelona	B
Spain	Research site	Girona
Spain	Research site	Terrassa	B
Thailand	Research Site 1	Bangkok
Thailand	Research Site 2	Bangkok
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Nonthaburi
United States	Research site	Chicago	Illinois
United States	Research site	Greensboro	North Carolina
United States	Research site	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Polyphor Ltd.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate		21-24 days after start of study treatment