Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT00192504
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
24 Months
Study:
NCT00192504
Study Brief:
Protocol Section:
NCT00192504