Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells
Phase 2/Phase 3
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Malignancy, Allogeneic Stem Cell Transplantation
Both
Malignancy, Allogeneic Stem Cell Transplantation
Trial Information
Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells
Inclusion Criteria:
- Allogeneic SCT
- Postneutropenic period
- Written consent
Exclusion Criteria:
- Fever
- Antibiotic therapy
- Neutropenia
- Refusal by the patient
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
Igor Wolfgang Blau, Dr.
Investigator Role:
Study Chair
Investigator Affiliation:
Charite, CBF, Berlin, Germany
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
Levosta-CBF-02/04
NCT ID:
NCT00215007
Start Date:
Completion Date:
Related Keywords:
- Malignancy
- Allogeneic Stem Cell Transplantation
- Neoplasms
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