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

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ClinicalTrials.gov Identifier: NCT00667303
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Respiratory Virus Infections Other: Nasopharyngeal Washes Other: Fluorescent antibody detection Other: Respiratory viral culture

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

Study Design

Study Type : Observational
Actual Enrollment : 51 participants
Time Perspective: Prospective
Official Title: Prospective Surveillance For Respiratory Virus Infections In Children Undergoing Hematopoietic Stem Cell Transplantation
Study Start Date : December 2007
Primary Completion Date : August 2011
Study Completion Date : August 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
1 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.

Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Biospecimen Retention:   Samples Without DNA
Nasopharyngeal washes Fluorescent antibody detection Respiratory viral culture

Eligibility Criteria

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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).

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667303

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Principal Investigator: Ashok Srinivasan, MD St. Jude Children's Research Hospital
More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00667303     History of Changes
Other Study ID Numbers: BMTRV
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

Keywords provided by St. Jude Children's Research Hospital:
Hematopoietic stem cell transplant

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs