Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation

December 28, 2009 updated by: University Children's Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients undergoing allogeneic stem cell transplantation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
LAmb
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Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital Tuebingen

Investigators

  • Principal Investigator: Ingo Mueller, M.D., UCHT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

December 28, 2009

First Posted (Estimate)

December 29, 2009

Study Record Updates

Last Update Posted (Estimate)

December 29, 2009

Last Update Submitted That Met QC Criteria

December 28, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCHT-1209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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