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NCT Number: NCT00398411

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.

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Key information

Conditions

Hodgkin Disease Bacteremia Bacterial Infections Bacterial Infections and Mycoses Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Infections Inflammation Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinikum der Universität zu Köln

Cologne, 50924, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moxifloxacin

Drug

400 mg p.o. per day

Other names: Avalox

Placebo

Drug

one tablet per day p.o.

Other names: placebo preparation

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study 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

Acronym: MoxiProph

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 10, 2006
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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