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 Combination Therapy (Ciprofloxacin Plus Amoxicillin/Clavulanic Acid)
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
Winfried Kern, MD
University Hospital Freiburg
United States: Federal Government