Study of the Efficacy and Safety of MEDI4893 (SAATELLITE)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Staphylococcus Aureus Pneumonia

Treatments: Drug: MEDI4893; Other: Placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02296320

CD-ID-MEDI4893-1139

Details and patient eligibility

About

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

Enrollment: 213 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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213 participants in 3 patient groups, including a placebo group

MEDI4893 5000 mg

Active Comparator group

Description:

Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.

Treatment:

Drug: MEDI4893

Placebo

Placebo Comparator group

Description:

Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.

Treatment:

Other: Placebo

MEDI4893 2000 mg

Active Comparator group

Description:

Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.

Treatment:

Drug: MEDI4893