NCT00448994

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

March 15, 2007

Last Update Submit

December 8, 2014

Conditions

AdenovirusOther Mycoses

Keywords

adenovirus, fungal, diagnostics, children

Outcome Measures

Primary Outcomes (1)

  • Method development

    3 years

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfections
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
VP, Scientific Affairs

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

March 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

US(2)