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Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients

NCT00026767 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 217

Last updated 2019-12-17

No results posted yet for this study

Summary

This study will collect data on the incidence (rate of occurrence) of fungal infections in recipients of bone marrow, stem cell or organ transplants. The data will provide information needed to develop strategies for prevention and early treatment of fungal infections in these patients.

Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or solid organ transplantation is eligible for this study.

The survey will be conducted over a 3-year period at about 20 collaborating transplant centers. Through the annual accrual of more than 9,000 patients, it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections.

The study will be conducted in three phases as follows:

* Phase 1 A 6-month "start-up" phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections.
* Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion.
* Phase 3 A 6-month "wrap-up" phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase.

Patient care will be provided through the patient s primary protocol and standard of care.

...

Conditions

  • Fungus Disease

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Crystal L Mackall, M.D. · National Cancer Institute (NCI)

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-09
Completion
2012-07-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00026767 on ClinicalTrials.gov