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

June 1, 2015 updated by: Oliver Cornely, MD, University of Cologne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Köln, Germany, 50924
        • Klinikum der Universität zu Köln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moxifloxacin
moxifloxacin 400 mg tablets once daily
Drug: moxifloxacin
400 mg p.o. per day
Other Names:
  • Avalox
Placebo Comparator: Placebo
identical appearing placebo
Drug: placebo
one tablet per day p.o.
Other Names:
  • placebo preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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
end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Type of Infection
Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
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)
follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Oliver A. Cornely, MD, Universität zu Köln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 8, 2006

First Submitted That Met QC Criteria

November 8, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05001
  • 2005-003271-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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