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

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ClinicalTrials.gov Identifier: NCT00398411
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : December 11, 2013
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Hodgkin Disease Non-Hodgkin Lymphoma Multiple Myeloma Bacteremia Drug: moxifloxacin Drug: placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
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
Study Start Date : October 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. 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) ]
  3. 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

  4. Type of Infection [ Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) ]
  5. Overall Survival [ Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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Germany
Klinikum der Universität zu Köln
Köln, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Oliver A. Cornely, MD Universität zu Köln
More Information
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Publications of Results:

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Responsible Party: Oliver Cornely, MD, Medical Director of the Center of Clinical Trials (ZKS), University of Cologne
ClinicalTrials.gov Identifier: NCT00398411    
Other Study ID Numbers: 05001
2005-003271-21 ( EudraCT Number )
First Posted: November 10, 2006    Key Record Dates
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:
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Bacteremia
Multiple Myeloma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors