- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667303
Prospective Surveillance For Respiratory Virus Infections In Children Undergoing Hematopoietic Stem Cell Transplantation
September 6, 2012 updated by: St. Jude Children's Research Hospital
The Study aims to prospectively survey the incidence of respiratory virus infections using molecular methodologies, in children undergoing hematopoietic stem cell transplantation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Samples will be collected with a nasopharyngeal wash and processed for direct fluorescent antibody, culture and Polymerase chain reaction (PCR)
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
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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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: All patients will be followed until day +100 after the HSCT.
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All patients will be followed until day +100 after the HSCT.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 24, 2008
First Submitted That Met QC Criteria
April 25, 2008
First Posted (Estimate)
April 28, 2008
Study Record Updates
Last Update Posted (Estimate)
September 7, 2012
Last Update Submitted That Met QC Criteria
September 6, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMTRV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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