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Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

NCT ID: NCT00448994

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-07-31

Brief Summary

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This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem cells are unspecialized cells, capable of producing more stem cells or other specialized cells, and are used to replace damaged or diseased cells. The study will be conducted in children (2-17years old) being transplanted with stem cells from a donor. Patients undergoing stem cell transplantation are more likely to develop infections as their immune systems are weakened. Blood, stool, urine and throat swab samples will be collected (for at least 100 days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. Subjects will participate for up to 1 year following the transplant procedure.

Detailed Description

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This study is a multi-center observational study to determine the usefulness of real time PCR in the detection of adenovirus and fungal infections in patients following HSCT. Quantitative viral load monitoring will be evaluated to establish correlation with clinical symptoms and to measure the effectiveness of the therapeutic interventions. Samples will be collected prior to HSCT and on a scheduled weekly basis for 100 days post-HSCT and after that when patients show signs of infection. Patients' signs and symptoms and outcomes will be recorded for correlation with viral load. In addition, viral cultures will be performed on the same schedule as PCR assay using 3 samples (throat swab, stool, and urine). The study will be conducted at approximately 6 centers in the United States.

Conditions

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Adenovirus Other Mycoses

Keywords

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adenovirus, fungal, diagnostics, children

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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Inclusion Criteria

1. Pediatric patients greater than or equal to 2 years of age.
2. Allogeneic HSCT.
3. Willing and able to give signed informed consent, or have a legally authorized representative who is willing to give consent. Informed assent will be required for children \<18 years of age.
4. Reliable and willing to make themselves available for the duration of the study.

Exclusion Criteria

1. Autologous transplant patients are not eligible for the study.
2. Patients previously enrolled in the study may not reenroll in the event of a subsequent HSCT.
3. Pediatric patients less than 2 years of age are not eligible for the study.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Steven B. Kleiboeker

INDUSTRY

Sponsor Role lead

Responsible Party

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Steven B. Kleiboeker

VP, Scientific Affairs

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Texas Transplant Institute

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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05-0101

Identifier Type: -

Identifier Source: org_study_id