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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02593851
Eligibility Criteria:
Inclusion Criteria:
* Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion
* Participant has been hospitalized for this suspected RSV infection
* Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)-based assay, preferably commercially available locally
* Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days)
* A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
Exclusion Criteria:
* Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study
* Participant has major congenital anomalies or known cytogenetic disorders
* Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
* Participant has known or suspected hepatitis B or C infection
* Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
24 Months
Study:
NCT02593851
Study Brief:
Protocol Section:
NCT02593851