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

Last updated: June 1, 2015
Sponsor: University of Cologne
Overall Status: Completed

Phase

3

Condition

Soft Tissue Infections

Bone Diseases

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT00398411
05001
2005-003271-21
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • High-dose chemotherapy followed by peripheral autologous stem cell transplantation

  • Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solidtumor

Exclusion

Exclusion Criteria:

  • Allogenic stem cell transplantation

  • Aplastic anemia

  • Antibiotic treatment within seven days prior to randomization

  • Signs and symptoms of current infection

Study Design

Total Participants: 66
Study Start date:
October 01, 2006
Estimated Completion Date:
December 31, 2008

Study 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.

Connect with a study center

  • Klinikum der Universität zu Köln

    Köln, 50924
    Germany

    Site Not Available

  • Klinikum der Universität zu Köln

    Köln, 50924
    Germany

    Site Not Available

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