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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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) ] [ 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.



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) ] [ 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 ]

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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 8, 2006
Results First Received: August 5, 2013
Last Updated: October 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 30, 2014