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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

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

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

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.

Effort to Prevent Nosocomial Pneumonia caused by Pseudomonas aeruginosa in Mechanically Ventilated Subjects

NCT ID

Patient Level Data

Therapeutic Area

Participants will receive a single IV dose of 500 mg or 1500 mg MEDI3902.

D5470C00004 Redacted SAP for CT.gov results

Research Site

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

Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.

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.

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.

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.

Age Continuous

Sex: Female, Male

Race/Ethnicity, Customized

The intent-to-treat (ITT) population is all randomized participants, grouped according to assigned treatment.

The modified intent to treat (mITT) population included all randomized and treated participants, grouped according to assigned treatment.

Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas aeruginosa

The As-treated population is all treated participants, grouped according to actual treatment received.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)

The As-treated population is all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this outcome measure.

Maximum Observed Concentration (Cmax) of MEDI3902

The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902

The CL of MEDI3902 from body after intrevanous administration of single dose is reported.

Clearance (CL) of MEDI3902

Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.

Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose

Terminal Elimination Half-life (t1/2) of MEDI3902

Positive at baseline and post-baseline

Persistent positive

Transient positive

Number of participants with positive ADA to MEDI3902 treatment is reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) 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 (with < 16 weeks between first and last positive).

Arms	Assigned Interventions
Experimental: MEDI3902 500 mg Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.	Drug: MEDI3902 Participants will receive a single IV dose of 500 mg or 1500 mg MEDI3902.
Placebo Comparator: Placebo Participants will receive a single IV dose of placebo matched to MEDI3902.	Other: Placebo Participants will receive a single IV dose of placebo matched to MEDI3902.
Experimental: MEDI3902 1500 mg Participants will receive a single IV dose of 1500 mg MEDI3902.	Drug: MEDI3902 Participants will receive a single IV dose of 500 mg or 1500 mg MEDI3902.

Effort to Prevent Nosocomial Pneumonia caused by Pseudomonas aeruginosa in Mechanically Ventilated Subjects - EVADE

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Redacted CSP for CT.gov results

D5470C00004 Redacted SAP for CT.gov results

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator