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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pseudomonas Aeruginosa

Intervention / Treatment
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* Drug: MEDI3902
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDI3902 500 mg<br>Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902. | Drug: MEDI3902<br>* Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a single IV dose of placebo matched to MEDI3902. | Other: Placebo<br>* Participants will receive a single IV dose of placebo matched to MEDI3902.<br>|
| Experimental: MEDI3902 1500 mg<br>Participants will receive a single IV dose of 1500 mg MEDI3902. | Drug: MEDI3902<br>* Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa | Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported. | Day 1 through Day 22 | 
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Day 1 through Day 50 | 
| Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 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. | Day 1 through Day 50 | 
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) | 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. | Day 1 through Day 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Concentration (Cmax) of MEDI3902 | The Cmax of MEDI3902 is reported. | Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 | 
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902 | The AUC0-inf of MEDI3902 is reported. | Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 | 
| Clearance (CL) of MEDI3902 | The CL of MEDI3902 from body after intrevanous administration of single dose is reported. | Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 | 
| Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose | Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported. | Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22 | 
| Terminal Elimination Half-life (t1/2) of MEDI3902 | The t1/2 of MEDI3902 is reported. | Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 | 
| Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment | 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. | Day 1 (predose), Day 15, Day 29, Day 50 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudomonas aeruginosa, Pneumonia