CompletedPhase 2

Study of the Efficacy and Safety of MEDI4893

United States, Belgium213 participantsStarted 2014-10-10

Plain-language summary

Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

Who can participate

Age range18 Years – 130 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia

Timeframe: Day 1 through Day 31

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days

Timeframe: Day 1 through Day 31

Number of Participants With TEAEs Through 91 Days

Timeframe: Day 1 through Day 91

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

Timeframe: Day 1 through Day 191

Number of Participants With Adverse Events of Special Interest (AESIs)

Timeframe: Day 1 through Day 191

Number of Participants With New Onset Chronic Diseases (NOCDs)

Timeframe: Day 1 through Day 191

Trial details

NCT IDNCT02296320

SponsorMedImmune LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-02

Results submitted2019-10-01

View on ClinicalTrials.gov More Staphylococcus Aureus Pneumonia trials