An observational study in Respiratory Virus Infections, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2012-09-07.
Sponsored by St. Jude Children's Research Hospital · Observational
The Study aims to prospectively survey the incidence of respiratory virus infections using molecular methodologies, in children undergoing hematopoietic stem cell transplantation
Samples will be collected with a nasopharyngeal wash and processed for direct fluorescent antibody, culture and Polymerase chain reaction (PCR)
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 51 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children, birth to 18 years old, within the first 100 days of a hematopoietic stem cell transplant who are either asymptomatic, or symptomatic with an upper respiratory tract infection (URTI) or a lower respiratory tract infection (LRTI).
Exclusion Criteria:
Other: Nasopharyngeal Washes · Other: Fluorescent antibody detection · Other: Respiratory viral culture
A total of eight nasopharyngeal washes will be done at the following time points: Prior to conditioning, on the day of admission and thereafter every two weeks until day +100 (Day +14, 28, 42, 56, 70, 84 and 98). To allow for flexibility over the weekends and holidays the specimen may be collected on the scheduled day ± 3 days. The baseline sample obtained prior to conditioning is required for patient to be considered evaluable.
For IF (Direct IF for hHRSV and indirect IF for the other viruses), the specimens will be spotted onto glass slides. Samples without respiratory epithelial cells will be considered inconclusive. Labelled antibodies against Flu A, Flu B, HPIV 1 to 3, RSV, hMPV and Adv will be used.
Shell vial culture specimens will be inoculated and incubated for 48 hours. The following RVs: Flu A, Flu B, HPIV 1-3, RSV, Adv and hMPV will be identified on the basis of cytopathic effects in cell cultures and confirmed by staining with fluorescein-conjugated monoclonal antibodies.
Incidence of RV infection at any time after transplant: The day of onset of an infection is defined as the day when the first positive diagnostic test was performed.
Time frame: All patients will be followed until day +100 after the HSCT.
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital