Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02696902 | Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects | PHASE2 | COMPLETED | 188 | — | — | Mar 25, 2016 | Dec 4, 2019 | Feb 4, 2021 | 78 | United States, Austria +12 |
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.
| Arm | Type | Description |
|---|---|---|
| MEDI3902 500 mg | EXPERIMENTAL | Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single IV dose of placebo matched to MEDI3902. |
| MEDI3902 1500 mg | EXPERIMENTAL | Participants will receive a single IV dose of 1500 mg MEDI3902. |
| Name | Type | Description |
|---|---|---|
| MEDI3902 | DRUG | 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. |
| Placebo | OTHER | Participants will receive a single IV dose of placebo matched to MEDI3902. |
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 r...