Moxifloxacin Prophylaxis: Moxifloxacin in the Prevention of Bacteremia After High-Dose Chemotherapy and Transplantation of Peripheral Stem Cells
Information source: University of Cologne
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hodgkin Disease; Non-Hodgkin Lymphoma; Multiple Myeloma; Bacteremia
Intervention: moxifloxacin (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Cologne Official(s) and/or principal investigator(s):
Oliver A. Cornely, MD, Principal Investigator, Affiliation: Universität zu Köln
Overall contact:
Oliver A. Cornely, MD, Phone: +49-221-478 6494, Email: oliver.cornely@uni-koeln.de
Summary
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.
Clinical Details
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
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: incidence of clinically significant bacteriemia
Secondary outcome: type of isolates and infectionsduration to occurrence of fever days of fever overall survival
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Oliver A. Cornely, MD, Phone: +49-221-478 6494, Email: oliver.cornely@uni-koeln.de
Klinikum der Universität zu Köln, Köln 50924, Germany; Recruiting
Dorothee Arenz, Phone: +49-221-478 6494, Email: dorothee.arenz@uni-koeln.de
Oliver A. Cornely, MD, Principal Investigator
Additional Information
Starting date: October 2006
Ending date: December 2007
Last updated: July 23, 2007
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