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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398411
First Posted: November 10, 2006
Last Update Posted: June 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Oliver Cornely, MD, University of Cologne:

Primary Outcome Measures:
  • 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) ]

    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.



Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
    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) ]
  • Overall Survival [ Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) ]

Enrollment: 66
Study Start Date: October 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxifloxacin
moxifloxacin 400 mg tablets once daily
Drug: moxifloxacin
400 mg p.o. per day
Other Name: Avalox
Placebo Comparator: Placebo
identical appearing placebo
Drug: placebo
one tablet per day p.o.
Other Name: placebo preparation

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398411


Locations
Germany
Klinikum der Universität zu Köln
Köln, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Oliver A. Cornely, MD Universität zu Köln
  More Information

Publications:
Responsible Party: Oliver Cornely, MD, Medical Director of the Center of Clinical Trials (ZKS), University of Cologne
ClinicalTrials.gov Identifier: NCT00398411     History of Changes
Other Study ID Numbers: 05001
2005-003271-21 ( EudraCT Number )
First Submitted: November 8, 2006
First Posted: November 10, 2006
Results First Submitted: August 5, 2013
Results First Posted: December 11, 2013
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Oliver Cornely, MD, University of Cologne:
prophylaxis
bacteremia
moxifloxacin
stem cell transplantation
Hodgkin disease
non-Hodgkin lymphoma
multiple myeloma
solid tumor
autologous stem cell transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Hodgkin Disease
Bacteremia
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents