Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062231
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2003-06-05
Brief Title:
Moxifloxacin Compared With CiprofloxacinAmoxicillin in Treating Fever and Neutropenia in Patients With Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
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 Combination Therapy Ciprofloxacin Plus AmoxicillinClavulanic Acid
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 physicians 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 ie 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
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 physicians 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-46001 | None | None | None |