Phase 2
Completed N=188
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Pseudomonas Aeruginosa
Source: ClinicalTrials.gov NCT02696902 ↗
Enrolled (actual)
188
Serious AEs
41.9%
Results posted
Dec 2020
Primary outcomePrimary: Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa — 18.1; 12.5; 22.4 Percentage of participants — p=0.491
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa |
18.1; 12.5; 22.4 | 0.491 |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
81; 15; 84 | — |
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) |
35; 4; 38 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) |
1; 0; 2 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of MEDI3902 |
87.6; 299 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902 |
440; 1510 | — |
| SECONDARY Clearance (CL) of MEDI3902 |
1.31; 1.27 | — |
| SECONDARY Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose |
50; 80.6 | — |
| SECONDARY Terminal Elimination Half-life (t1/2) of MEDI3902 |
6.56; 5.65 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment |
3; 2; 1; 4; 2; 4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02696902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.