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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne
ClinicalTrials.gov Identifier:
NCT00398411
First received: November 8, 2006
Last updated: October 16, 2013
Last verified: October 2013

November 8, 2006
October 16, 2013
October 2006
December 2008   (final data collection date for primary outcome measure)
Incidence of Clinically Significant Bacteremia [ Time Frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) ] [ Designated as safety issue: No ]

Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.

With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.

incidence of clinically significant bacteriemia
Complete list of historical versions of study NCT00398411 on ClinicalTrials.gov Archive Site
  • Type of Isolates and Infections [ Time Frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) ] [ Designated as safety issue: No ]
  • Time to Occurrence of Fever >= 38°C [ Time Frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) ] [ Designated as safety issue: No ]
  • Reason for Discontinuation of Treatment [ Time Frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) ] [ Designated as safety issue: No ]
    Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason
  • Type of Infection [ Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) ] [ Designated as safety issue: Yes ]
  • type of isolates and infections
  • duration to occurrence of fever
  • days of fever
  • overall survival
Not Provided
Not Provided
 
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Hodgkin Disease
  • Non-Hodgkin Lymphoma
  • Multiple Myeloma
  • Bacteremia
  • Drug: moxifloxacin
    400 mg p.o. per day
    Other Name: Avalox
  • Drug: placebo
    one tablet per day p.o.
  • Experimental: Moxifloxacin
    moxifloxacin 400 mg tablets once daily
    Intervention: Drug: moxifloxacin
  • Placebo Comparator: Placebo
    identical appearing placebo
    Intervention: Drug: placebo
Vehreschild JJ, Moritz G, Vehreschild MJ, Arenz D, Mahne M, Bredenfeld H, Chemnitz J, Klein F, Cremer B, Böll B, Kaul I, Wassmer G, Hallek M, Scheid C, Cornely OA. Efficacy and safety of moxifloxacin as antibacterial prophylaxis for patients receiving autologous haematopoietic stem cell transplantation: a randomised trial. Int J Antimicrob Agents. 2012 Feb;39(2):130-4. doi: 10.1016/j.ijantimicag.2011.10.009. Epub 2011 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00398411
05001, 2005-003271-21
Yes
Oliver Cornely, MD, University of Cologne
University of Cologne
Not Provided
Principal Investigator: Oliver A. Cornely, MD Universität zu Köln
University of Cologne
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP