Trials / Terminated

TerminatedNCT00062231

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

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)

Status: Terminated
Phase: N/A
Study type: Interventional
Enrollment: 351 (actual)

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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 description

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.

Conditions

Interventions

Type	Name	Description
DRUG	amoxicillin-clavulanate potassium
DRUG	ciprofloxacin
DRUG	moxifloxacin hydrochloride
PROCEDURE	management of therapy complications

Timeline

Start date: 2002-04-01
Primary completion: 2006-10-01
First posted: 2003-06-06
Last updated: 2012-09-24

Locations

23 sites across 8 countries: Belgium, France, Germany, Israel, Italy, Slovakia, Switzerland, Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT00062231. Inclusion in this directory is not an endorsement.