Clinical trial NCT00448994: Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Adenovirus
Other Mycoses
Keywords: adenovirus, fungal, diagnostics, children
Lead sponsor: ViraCor Laboratories
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2007-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Method development
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: San Antonio
country: United States
facility: Texas Transplant Institute
state: Texas
Study officials:
References: