Moxifloxacin Prophylaxis: Moxifloxacin in the Prevention of Bacteremia After High-Dose Chemotherapy and Transplantation of Peripheral Stem Cells
This study has been completed.
Sponsor:
University of Cologne
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00398411
First received: November 8, 2006
Last updated: March 11, 2009
Last verified: March 2009
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Purpose
This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.
Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin Disease Non-Hodgkin Lymphoma Multiple Myeloma Bacteremia |
Drug: moxifloxacin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Cologne:
Primary Outcome Measures:
- incidence of clinically significant bacteremia [ Time Frame: during treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- type of isolates and infections [ Time Frame: at end of treatment ] [ Designated as safety issue: No ]
- time to occurrence of fever [ Time Frame: during treatment ] [ Designated as safety issue: No ]
- days of fever [ Time Frame: follow up ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: follow up 28 days after stem cell transplantation ] [ Designated as safety issue: Yes ]
| Enrollment: | 68 |
| Study Start Date: | October 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: moxifloxacin
400 mg p.o. per day
Drug: placebo
one tablet per day p.o.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Prof. Dr. med. Oliver Cornely, University Hospital of Cologne |
| ClinicalTrials.gov Identifier: | NCT00398411 History of Changes |
| Other Study ID Numbers: | 05001, EudraCT-No. 2005-003271-21 |
| Study First Received: | November 8, 2006 |
| Last Updated: | March 11, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Cologne:
|
prophylaxis bacteremia moxifloxacin stem cell transplantation Hodgkin disease |
non-Hodgkin lymphoma multiple myeloma solid tumor autologous stem cell transplantation |
Additional relevant MeSH terms:
|
Bacteremia Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013