Trial Information
Double-Blind, Prospective, Randomized, Mono-Center, Placebo-Controlled Pilot Study to Investigate the Efficacy and Safety of Moxifloxacin in the Prevention of Bacteremia After High-Dose Chemotherapy and Transplantation of Peripheral Stem Cells
Inclusion Criteria:
- High-dose chemotherapy followed by peripheral autologous stem cell transplantation
- Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid
tumor
Exclusion Criteria:
- Allogenic stem cell transplantation
- Aplastic anemia
- Antibiotic treatment within seven days prior to randomization
- Signs and symptoms of current infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
incidence of clinically significant bacteremia
Outcome Time Frame:
during treatment
Safety Issue:
No
Principal Investigator
Oliver A. Cornely, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universität zu Köln
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
05001
NCT ID:
NCT00398411
Start Date:
October 2006
Completion Date:
December 2008
Related Keywords:
- Hodgkin Disease
- Non-Hodgkin Lymphoma
- Multiple Myeloma
- Bacteremia
- prophylaxis
- bacteremia
- moxifloxacin
- stem cell transplantation
- Hodgkin disease
- non-Hodgkin lymphoma
- multiple myeloma
- solid tumor
- autologous stem cell transplantation
- Bacteremia
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell