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

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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

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

Trial documents
2

Trial contacts and locations

78

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Data sourced from clinicaltrials.gov

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