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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Up to 18 years
• All sexes
• No healthy volunteers
• Child, Adult

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).

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Respiratory Virus Infections

Being tested

Nasopharyngeal Washes, Fluorescent antibody detection, Respiratory viral culture

Keywords

Hematopoietic stem cell transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Nasopharyngeal WashesOther

  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 detectionOther

  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 cultureOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Apr 2008 (estimated)
2. Study startDec 2007
3. Primary completionAug 2011
4. Study completionAug 2012

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Respiratory Virus InfectionsStudies of the same condition, open and under way.
• More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.