Status:
TERMINATED
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
Lead Sponsor:
MedImmune LLC
Conditions:
Participants Less Than 12 Months of Age With RSV Illness
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
Brief Summary
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 le...
Detailed Description
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 20 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00435227
Start Date
March 20 2007
End Date
May 31 2008
Last Update
August 17 2021
Active Locations (31)
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1
Research Site
Tucson, Arizona, United States
2
Research Site
Jonesboro, Arkansas, United States, 72401
3
Research Site
Jonesboro, Arkansas, United States
4
Research Site
Little Rock, Arkansas, United States, 72202