A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

Summary

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.

Timeline

Start

2007-01-10

Primary completion

2009-09-17

Completion

2009-09-17

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Motavizumab 30 mg/kg; p = 0.218; Wilcoxon's rank-sum test NCT00421304 ↗

paper Motavizumab had no appreciable effect on RSV viral load measured in the upper respiratory tract of children hospitalized for RSV lower respiratory tract infection. PMID 24356256 ↗

Publications

• Ramilo O, Lagos R, Saez-Llorens X, Suzich J, Wang CK, Jensen KM, Harris BS, Losonsky GA, Griffin MP; Motavizumab Study Group. Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. Pediatr Infect Dis J. 2014 Jul;33(7):703-9. doi: 10.1097/INF.0000000000000240.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Motavizumab	Monoclonal antibody	30 mg/kg	Intravenous
Subject	Motavizumab	Monoclonal antibody	100 mg/kg	Intravenous

Indications