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.
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. * Arm II: Patients receive oral ciprofloxacin and oral amoxicillin-clavulanate potassium twice daily. Patients also receive oral moxifloxacin placebo once daily. Patients with fever classified as not related to infection (i.e., doubtful) stop antibiotic therapy on day 3. All other patients receive antibiotics until complete resolution of infection, or until failure is determined or anticipated, for up to 28 days. Patients are followed at 7-10 days. PROJECTED ACCRUAL: A total of 530 patients (265 patients per treatment arm) will be accrued for this study within approximately 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
351
Hopital Universitaire Erasme
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Institut Bergonie
Bordeaux, France
Institut Curie Hopital
Paris, France
Charite - Campus Charite Mitte
Berlin, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany
Klinikum der Albert - Ludwigs - Universitaet Freiburg
Freiburg im Breisgau, Germany
Ruprecht - Karls - Universitaet Heidelberg
Heidelberg, Germany
...and 13 more locations
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
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
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