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Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by:
University Children’s Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01040156
First received: December 28, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis.


Condition
Systemic Aspergillosis
Systemic Candidiasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety, Feasibility and Efficacy of Caspofungin Versus Liposomal Amphotericin B as Antifungal Prophylaxis Following Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients - a Retrospective Phase I/II Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Children’s Hospital Tuebingen:

Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients undergoing allogeneic stem cell transplantation

Criteria

Inclusion Criteria:

  • Pediatric patients under the age of 18 years
  • Pediatric patients after HSCT treated with caspofungin
  • Pediatric patients after HSCT treated with liposomal amphotericin

Exclusion Criteria:

  • Pediatric patients with uncontrolled hematological malignancies
  • Pediatric patients with IFI at start of HSCT
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040156

Locations
Germany
University Children's Hospital
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Children’s Hospital Tuebingen
Investigators
Principal Investigator: Ingo Mueller, M.D. UCHT
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01040156     History of Changes
Other Study ID Numbers: UCHT-1209
Study First Received: December 28, 2009
Last Updated: December 28, 2009
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Aspergillosis
Candidiasis
Mycoses
Liposomal amphotericin B
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents

ClinicalTrials.gov processed this record on May 22, 2013