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| Sponsor: | University of Cologne |
|---|---|
| Information provided by: | University of Cologne |
| ClinicalTrials.gov Identifier: | NCT00398411 |
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 III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | University Hospital of Cologne ( Prof. Dr. med. Oliver Cornely ) |
| Study ID Numbers: | 05001, EudraCT-No. 2005-003271-21 |
| Study First Received: | November 8, 2006 |
| Last Updated: | March 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00398411 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
prophylaxis bacteremia moxifloxacin stem cell transplantation Hodgkin disease |
non-Hodgkin lymphoma multiple myeloma solid tumor autologous stem cell transplantation |
|
Bacterial Infections Anti-Infective Agents Blood Protein Disorders Paraproteinemias Infection Hemostatic Disorders Pathologic Processes Hemorrhagic Disorders Moxifloxacin Therapeutic Uses Cardiovascular Diseases Lymphoma Hodgkin Disease Systemic Inflammatory Response Syndrome Neoplasms by Histologic Type |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Vascular Diseases Bacteremia Pharmacologic Actions Inflammation Multiple Myeloma Lymphatic Diseases Sepsis Neoplasms Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms, Plasma Cell |