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Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01040156
First Posted: December 29, 2009
Last Update Posted: December 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Children’s Hospital Tuebingen
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01040156     History of Changes
Other Study ID Numbers: UCHT-1209
First Submitted: December 28, 2009
First Posted: December 29, 2009
Last Update Posted: December 29, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Candidiasis
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents