Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

December 8, 2014 updated by: Steven B. Kleiboeker

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

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

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

United States
- Missouri
  - Kansas City, Missouri, United States, 64108
    - Children's Mercy Hospital
- Texas
  - San Antonio, Texas, United States, 78229
    - Texas Transplant Institute

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

2 years to 17 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric

Description

Inclusion Criteria:

Pediatric patients greater than or equal to 2 years of age.
Allogeneic HSCT.
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.
Reliable and willing to make themselves available for the duration of the study.

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Method development Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steven B. Kleiboeker

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

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

March 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria