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

Phase 2

Completed

Conditions: Pseudomonas Aeruginosa

Interventions: Drug: MEDI3902
Other: Placebo

Registration Number: NCT02696902

Lead Sponsor: MedImmune LLC

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 188

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDI3902 500 mg	MEDI3902	Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.
Placebo	Placebo	Participants will receive a single IV dose of placebo matched to MEDI3902.
MEDI3902 1500 mg	MEDI3902	Participants will receive a single IV dose of 1500 mg MEDI3902.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa	Day 1 through Day 22	Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Day 1 through Day 50	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	Day 1 through Day 50	An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)	Day 1 through Day 50	An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Concentration (Cmax) of MEDI3902	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50	The Cmax of MEDI3902 is reported.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50	The AUC0-inf of MEDI3902 is reported.
Clearance (CL) of MEDI3902	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50	The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22	Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.
Terminal Elimination Half-life (t1/2) of MEDI3902	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50	The t1/2 of MEDI3902 is reported.
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment	Day 1 (predose), Day 15, Day 29, Day 50	Number of participants with positive ADA to MEDI3902 treatment is reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments.