A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Participants Less Than 12 Months of Age With RSV Illness

In brief

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.

Key facts

Study ID

NCT00435227

Run by

MedImmune LLC

People needed

12

Starts

2007-03-20

Expected to finish

2008-05-31

Last updated by the study team

2021-08-17

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously healthy
• Age ≤12 months at the time of randomization
• Weight ≤10 kg at the time of randomization
• Gestational age ≥36 weeks
• RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
• Documented stable clinical condition that does not require hospitalization (oxygen saturation ≥ 95%; respiratory rate < 60 breaths/minute in children < 2 months and < 50 breaths/minute in children 2-12 months)
• Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more than 1 point assigned for each of the 6 assessment categories) at baseline evaluation
• Randomization within 4 hours of being evaluated with a positive Binax® RSV test
• Written informed consent obtained from the participant's parent(s) or legal guardian

You may not qualify if…

• Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
• Prior medically diagnosed RSV infection
• Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
• Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
• Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
• Requirement for supplemental oxygen (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
• Mechanical ventilation at any time prior to the onset of the current RSV infection
• Congenital heart disease [children with medically or surgically closed patent ductus arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
• Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
• Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
• Prior use of palivizumab (Synagis®) within the past 2 months
• Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
• Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Orange, California, United States
• Research Site — San Diego, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Paterson, New Jersey, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Buffalo, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Youngstown, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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