Status:
COMPLETED
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
Lead Sponsor:
MedImmune LLC
Conditions:
Respiratory Syncytial Virus Prophylaxis
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
Detailed Description
This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunoge...
Eligibility Criteria
Inclusion
- Previously healthy
- Age 24 months and younger at the time of randomization
- Gestational age of 36 weeks gestation and older
- Randomization within 24 hours after hospitalization
- Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization
Exclusion
- Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
- Required intubation for ventilatory support
- Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
- Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
- Mechanical ventilation at any time prior to the onset of the current RSV infection
- Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus \[PDA\], small atrial septal defect \[ASD\] or ventricular septal defect \[VSD\] were allowed)
- Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
- Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products 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 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00192504
Start Date
March 1 2004
End Date
January 1 2005
Last Update
October 8 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.