Clinical trial NCT03409679: Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical cure rate
timeFrame: 21-24 days after start of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Research site
state: Illinois
city: Springfield
country: United States
facility: Research site
state: Missouri
city: Greensboro
country: United States
facility: Research site
state: North Carolina
city: Belo Horizonte
country: Brazil
facility: Research Site 1
city: Belo Horizonte
country: Brazil
facility: Research Site 2
city: Itaquaquecetuba
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: São José Do Rio Preto
country: Brazil
facility: Research Site
city: Zagreb
country: Croatia
facility: Research site 1
city: Zagreb
country: Croatia
facility: Research site 2
city: Tallinn
country: Estonia
facility: Research site
city: Tartu
country: Estonia
facility: Reasearch site
city: Võru
country: Estonia
facility: Reasearch site
city: Lille
country: France
facility: Research site
city: Limoges
country: France
facility: Reasearch site
city: Lyon
country: France
facility: Research site
city: Nice
country: France
facility: Reasearch site
city: Paris
country: France
facility: Research site 1
city: Paris
country: France
facility: Research site 2
city: Paris
country: France
facility: Research site 3
city: Pierre-Bénite
country: France
facility: Research site
city: Athens
country: Greece
facility: Research Site
city: Ioánnina
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site 1
city: Larissa
country: Greece
facility: Research Site 2
city: Patra
country: Greece
facility: Research Site
city: Thessaloníki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Reasearch site
state: BU
city: Budapest
country: Hungary
facility: Research site
state: BU
city: Ózd
country: Hungary
facility: Reasearch site
state: BZ
city: Kistarcsa
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Vác
country: Hungary
facility: Research Site
city: Jerusalem
country: Israel
facility: Research site
state: JM
city: Nahariya
country: Israel
facility: Research site
state: Z
city: Tiberias
country: Israel
facility: Research site
state: Z
city: Petah Tiqva
country: Israel
facility: Research site
city: Tel HaShomer
country: Israel
facility: Research site
city: Zefat
country: Israel
facility: Research site
city: Ansansi Danweongu
country: Korea, Republic of
facility: Research Site
city: Gangwon-do
country: Korea, Republic of
facility: Research Site
city: Gyeongsang
country: Korea, Republic of
facility: Research site
city: Incheon
country: Korea, Republic of
facility: Research site
city: Seoul
country: Korea, Republic of
facility: Research site 1
city: Seoul
country: Korea, Republic of
facility: Research site 2
city: Seoul
country: Korea, Republic of
facility: Research Site 3
city: Seoul
country: Korea, Republic of
facility: Research site
city: Guadalajara
country: Mexico
facility: Research Site 1
city: Guadalajara
country: Mexico
facility: Research Site 2
city: Monterrey
country: Mexico
facility: Research Site
city: Tshwane
country: South Africa
facility: Research site 1
state: Gauteng
city: Cape Town
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Tshwane
country: South Africa
facility: Research Site 2
city: Barcelona
country: Spain
facility: Research site
state: B
city: Terrassa
country: Spain
facility: Research site
state: B
city: Girona
country: Spain
facility: Research site
city: Bangkok
country: Thailand
facility: Research Site 1
city: Bangkok
country: Thailand
facility: Research Site 2
city: Khon Kaen
country: Thailand
facility: Research Site
city: Nonthaburi
country: Thailand
facility: Research Site
Study officials:
References: