Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects (EVADE)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Pseudomonas Aeruginosa

Treatments: Drug: MEDI3902; Other: Placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02696902

D5470C00004

Details and patient eligibility

About

Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

Enrollment: 188 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion criteria

P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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188 participants in 3 patient groups, including a placebo group

MEDI3902 500 mg

Experimental group

Description:

Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.

Treatment:

Drug: MEDI3902

Placebo

Placebo Comparator group

Description:

Participants will receive a single IV dose of placebo matched to MEDI3902.

Treatment:

Other: Placebo

MEDI3902 1500 mg

Experimental group

Description:

Participants will receive a single IV dose of 1500 mg MEDI3902.

Treatment:

Drug: MEDI3902