Clinical Trial: Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Oral Empirical Therapy of Fever in Low-Risk Neutropenic Cancer Patients: A Prospective, Double-Blind, Randomized, Multicenter Trial Comparing Monotherapy (Single Daily Dose Moxifloxacin) With Combinat

Brief Summary:

RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever.

PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.


Detailed Summary:

OBJECTIVES:

  • Compare the rates of successful response to moxifloxacin vs ciprofloxacin in combination with amoxicillin-clavulanate potassium in low-risk febrile neutropenic patients with cancer.
  • Compare the time to discharge, time to discontinuation of any antimicrobial therapy, and time to defervescence of patients treated with these regimens.
  • Compare 28-day survival of patients treated with these regimens.
  • Determine the proportion of these patients who are eligible for oral therapy and a therapeutic management including intention of early discharge.
  • Determine the medical and nonmedical reasons for continued in-hospital observation and care or for readmission of these patients.
  • Determine the accuracy of the physician's estimate of further neutropenia duration and evaluate its predictive value in these patients.
  • Validate the Multinational Association for Supportive Care in Cancer low-risk prediction rule to predict the absence of serious medical complications in the setting of oral therapy in in- and outpatients.

OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to institution, underlying disease (hematologic malignancy vs other), pretreatment with no more than a single dose (yes vs no), and outpatient status at fever onset (yes vs no). Patients are randomized into 1 of 2 treatment arms.

  • Arm I: Patients receive oral moxifloxacin once daily. Patients also receive oral ciprofloxacin placebo and oral amoxicillin-clavulanate potassium placebo twice daily.<
    Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

    Current Primary Outcome: Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment

    Original Primary Outcome:

    Current Secondary Outcome:

    • Rate of complication as measured by Multinational Association for Supportive Care in Cancer (MASCC) criteria at the end of febrile neutropenic episode
    • Time to discharge as measured by Logrank continuously until the end of febrile neutropenic episode
    • Time to defervescence as measured by Logrank continuously until the end of febrile neutropenic episode
    • Survival status as measured by Logrank at day 28


    Original Secondary Outcome:

    Information By: European Organisation for Research and Treatment of Cancer - EORTC

    Dates:
    Date Received: June 5, 2003
    Date Started: April 2002
    Date Completion:
    Last Updated: September 20, 2012
    Last Verified: September 2012