NCT00667303

Prospective Surveillance For Respiratory Virus Infections In Children Undergoing Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Study aims to prospectively survey the incidence of respiratory virus infections using molecular methodologies, in children undergoing hematopoietic stem cell transplantation

Detailed description

Samples will be collected with a nasopharyngeal wash and processed for direct fluorescent antibody, culture and Polymerase chain reaction (PCR)

Conditions

• Respiratory Virus Infections

Interventions

Type	Name	Description
OTHER	Nasopharyngeal Washes	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.
OTHER	Fluorescent antibody detection	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.
OTHER	Respiratory viral culture	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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-08-01
• Completion: 2012-08-01
• First posted: 2008-04-28
• Last updated: 2012-09-07

Locations

1 site across 1 country: United States