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

NCT00667303 | Completed

• 1 other identifier: BMTRV
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Virus Infections

Keywords

Hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (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.

  All patients will be followed until day +100 after the HSCT.

Study Arms (1)

1

Other: Nasopharyngeal Washes; Other: Fluorescent antibody detection; Other: Respiratory viral culture

Interventions

Nasopharyngeal Washes OTHER

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.

1

Fluorescent antibody detection OTHER

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.

1

Respiratory viral culture OTHER

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.

1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• Age: Birth to 18 years.
• Patients undergoing an allogeneic HSCT for any disease.
• Parent or guardian willing to sign informed consent.

You may not qualify if:

• Intra nasal lesion which precludes the performance of the nasopharyngeal wash.
• Patients on Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP).

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal washes Fluorescent antibody detection Respiratory viral culture

Study Officials

• Ashok Srinivasan, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)