Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects

Phase 2 Completed 188 enrolled MedImmune LLC Antibacterial Resistance Leadership Group · collab Innovative Medicines Initiative · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2016-03-25
Primary completion: 2019-12-04
Completion: 2019-12-04

Outcome

Missed primary endpoint

registry p = 0.491; Relative risk reduction -23.7 (80% CI -83.8 to 16.8) NCT02696902 ↗

paper did not reduce PA nosocomial pneumonia incidence in PA-colonised mechanically ventilated subjects. PMID 36380312 ↗

Publications

Chastre J, Francois B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sanchez-Garcia M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	gremubamab	Monoclonal antibody	500 mg	Intravenous
Subject	gremubamab	Monoclonal antibody	1500 mg	Intravenous