Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

Adenovirus Clinical Trial

Official title:

Serial Monitoring of Adenovirus and Fungal Load by Real-Time, Quantitative Polymerase Chain Reaction (PCR) Assay and Correlation With Outcomes in Pediatric Hematopoietic Stem Cell Transplant Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00448994
• Other study ID #: 05-0101
• Status: Withdrawn
• Phase: N/A
• First received: March 15, 2007
• Last updated: December 8, 2014
• Start date: March 2007
• Est. completion date: July 2011

Study information

• Verified date: December 2014
• Source: ViraCor Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus
• Other Mycoses

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Texas Transplant Institute	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Steven B. Kleiboeker	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Method development		3 years	No