Clincosm LogoSign in Get a demo

Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation

Sponsor
University Children's Hospital Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT01040156
Collaborator
(none)
1
Location
16
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    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
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Dec 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    LAmb
    Cas

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 18 Years
      Sexes Eligible for Study:
      All
      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

      Locations

      Site City State Country Postal Code
      1 University Children's Hospital Tuebingen Germany 72076

      Sponsors and Collaborators

      • University Children's Hospital Tuebingen

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01040156
      Other Study ID Numbers:
      • UCHT-1209
      First Posted:
      Dec 29, 2009
      Last Update Posted:
      Dec 29, 2009
      Last Verified:
      Dec 1, 2009
      Additional relevant MeSH terms:
      Candidiasis
      Aspergillosis

      Study Results

      No Results Posted as of Dec 29, 2009