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Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells

Information source: University of Cologne
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: University of Cologne

Official(s) and/or principal investigator(s):
Oliver A. Cornely, MD, Principal Investigator, Affiliation: Universität zu Köln

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, 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Incidence of Clinically Significant Bacteremia

Secondary outcome:

Type of Isolates and Infections

Time to Occurrence of Fever >= 38°C

Reason for Discontinuation of Treatment

Type of Infection

Overall Survival

Detailed description: Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.

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

Klinikum der Universität zu Köln, Köln 50924, Germany
Additional Information

Starting date: October 2006
Last updated: June 1, 2015

Page last updated: August 23, 2015

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