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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00667303

Enrollment

Registered

2008-04-28

Start date

2007-12-31

Completion date

2012-08-31

Last updated

2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Virus Infections

Keywords

Hematopoietic stem cell transplant

Brief 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)

Interventions

OTHERNasopharyngeal 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.

OTHERFluorescent 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.

OTHERRespiratory 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.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026