Phase 2
N=213
Study of the Efficacy and Safety of MEDI4893
Staphylococcus Aureus Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT02296320 ↗Enrolled (actual)
213
Serious AEs
46.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia — 26.0; 20.0; 17.7 Percentage of Participants — p=0.166
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI4893 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia |
26.0; 20.0; 17.7 | 0.166 |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days |
90; 15; 87 | — |
| PRIMARY Number of Participants With TEAEs Through 91 Days |
92; 15; 89 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) |
40; 7; 50 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESIs) |
0; 4; 3 | — |
| PRIMARY Number of Participants With New Onset Chronic Diseases (NOCDs) |
2; 0; 3 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of MEDI4893 |
471.9; 1143.7 | — |
| SECONDARY Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893 |
9045.5; 20127.5 | — |
| SECONDARY Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30) |
122.0; 295.9 | — |
| SECONDARY Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90) |
71.5; 192.0 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893 |
3; 0; 2; 5; 0; 0 | — |
Summary
Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
Eligibility Criteria
Inclusion Criteria
- Colonized with Staphylococcus aureus, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Exclusion Criteria
- Staphylococcal disease at randomisation; lung injury score consistent with pneumonia; current lung disease; chronic tracheostomy patients; currently receiving systemic anti-staphylococcal antibiotics; moribund patients.
Data sourced from ClinicalTrials.gov (NCT02296320). 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.