Clinical Trials Logo
  1. Home
  2. Respiratory Virus Infections
  3. NCT00667303
  4. Details
NCT00667303 Clinical Trial

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

Respiratory Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00667303
Other study ID # BMTRV
Secondary ID
Status Completed
Phase N/A
First received April 24, 2008
Last updated September 6, 2012
Start date December 2007
Est. completion date August 2012

Study information
Verified date September 2012
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date August 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Age: Birth to 18 years.

- Patients undergoing an allogeneic HSCT for any disease.

- Parent or guardian willing to sign informed consent.

Exclusion Criteria:

- Intra nasal lesion which precludes the performance of the nasopharyngeal wash.

- Patients on Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (1)
Lead Sponsor Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. All patients will be followed until day +100 after the HSCT. No

External Links