Phase 2
N=188
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Pseudomonas Aeruginosa
Bottom Line
View on ClinicalTrials.gov: NCT02696902 ↗Enrolled (actual)
188
Serious AEs
41.9%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa — 18.1; 12.5; 22.4 Percentage of participants — p=0.491
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI3902 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Dec 2019
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 | — |
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.
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.