Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

Withdrawn

• Conditions: Other Mycoses; Adenovirus

• Registration Number: NCT00448994
• Lead Sponsor: Steven B. Kleiboeker

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-19
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Method development	3 years

Trial Locations

Locations (2)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Texas Transplant Institute; 🇺🇸 San Antonio, Texas, United States