Clinical trial looking at the safety and efficacy of MEDI3902 in the prevention of Pseudomonas aeruginosa pneumonia occurring in the hospital

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2015-001706-34-ES
• Date of registration: 10/12/2015
• Prospective Registration: Yes
• Primary sponsor: MedImmune, LLC
• Public title: Clinical trial looking at the safety and efficacy of MEDI3902 in the prevention of Pseudomonas aeruginosa pneumonia occurring in the hospital
• Scientific title: A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa. - EVADE
• Date of first enrolment: 07/03/2016
• Target sample size: 429
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001706-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Croatia, Czech Republic, France, Germany, Greece, Hungary, Israel, Portugal, Romania, Slovakia, Spain, Switzerland, Turkey, United Kingdom

Contacts

• Name: Clinical Trial Enquiries
• Affiliation: MedImmune

• Name: Clinical Trial Enquiries
• Affiliation: MedImmune

Key inclusion & exclusion criteria

Inclusion criteria:
Colonized with Pseudomonas aeruginosa in respiratory tract, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 214

Exclusion criteria:
Pseudomonas disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving anti-pseudomonas antibiotics; moribund patients.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa
MedDRA version: 18.1 Level: LLT Classification code 10051190 Term: Pneumonia Pseudomonas aeruginosa System Organ Class: 100000004862

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Product Name: MEDI3902
Product Code: MEDI3902
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: MEDI3902
Other descriptive name: MEDI3902
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: 1. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa
2. To evaluate the safety of a single IV dose of MEDI3902 in mechanically ventilated patients

Secondary Objective: 1. To evaluate the serum pharmacokinetics (PK) of MEDI3902
2. To evaluate the serum anti-drug antibody (ADA) responses to MEDI3902
3. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa by mechanical ventilation status

Primary end point(s): - Incidence of nosocomial pneumonia caused by P aeruginosa

- Treatment emergent adverse events (TEAEs) treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs) through 49 days postdose

Timepoint(s) of evaluation of this end point: Through 49 days postdose

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Through 49 days postdose

Secondary end point(s): 1. MEDI3902 serum concentration and PK parameters
2. MEDI3902 ADA response in serum
3. Incidence of nosocomial pneumonia caused by P aeruginosa while on mechanical ventilation
4. Incidence of nosocomial pneumonia caused by P aeruginosa after mechanical ventilation is no longer required

Secondary ID(s)

D5470C00004

Source(s) of Monetary Support

MedImmune, LLC

Ethics review

Status: Approved
Approval date: 18/01/2016
Contact: