Status:
COMPLETED
An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
Lead Sponsor:
AstraZeneca
Conditions:
Respiratory Syncytial Virus Hospitalizations
Eligibility:
All Genders
Up to 12 years
Brief Summary
Purpose of this study is to evaluate clinical, humanistic and health economic burden of Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA) hospitalized for RSV at u...
Detailed Description
This surveillance study will enroll approximately 500 eligible infants from approximately 40 study sites in the US, hospitalized for laboratory-confirmed, nosocomial or community-acquired RSV disease ...
Eligibility Criteria
Inclusion
- Born at 29 to 35 wGA (i.e., 29 weeks, 0 days through 35 weeks, 6 days)
- Laboratory-confirmed, nosocomial or community-acquired RSV disease (RSV can be documented in the outpatient and/or inpatient setting during the illness that resulted in the index hospitalization)
- Hospitalized ≥24 hours for the diagnosed RSV disease (the index RSVH)
- \<12 months of age at time of index RSVH admission
- Written informed consent and any locally required authorization (e.g., HIPAA), obtained from the infant's Parent/Guardian
Exclusion
- \- Receipt of RSV immunoprophylaxis within the 35 days prior to onset of respiratory symptoms associated with the index RSVH
Key Trial Info
Start Date :
November 17 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 19 2016
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT02273882
Start Date
November 17 2014
End Date
August 19 2016
Last Update
May 23 2017
Active Locations (44)
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1
Research Site
Little Rock, Arkansas, United States
2
Research Site
Loma Linda, California, United States
3
Research Site
Long Beach, California, United States
4
Research Site
Los Angeles, California, United States