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Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer Clinical research trials and Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer. Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer  Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
For Condition: Infection,hematopoietic and lymphoid cancer,Neutropenia,adult solid tumor,fever, sweats, and hot flashes
Status: Recruiting
Sponsor(s): EORTC International Antimicrobial Therapy Group ,
Synopsis: 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: Randomized clinical trial to compare the effectiveness of moxifloxacin with that of ciprofloxacin combined with amoxicillin in treating neutropenia and fever in patients who have cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of cancer with developing febrile neutropenia - Neutropenia defined as an absolute granulocyte count of less than 1,000/mm^3, expected to fall to less than 500/mm^3 within 24 hours, secondary to administration of chemotherapy and/or radiotherapy within the past 30 days - Fever defined as an oral temperature greater than 38.5ºC once, or 38°C or greater on 2 or more occasions at least 1 hour apart during a 12-hour period, and suspected to be due to infection - Expected low risk of serious medical complications as predicted by a Multinational Association for Supportive Care in Cancer risk-index score of greater than 20 - No obvious signs of exit-site or tunnel intravascular catheter infection - No known or suspected CNS infection - No known or highly suspected bacterial, viral, or fungal infection PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - No high probability of death within 48 hours before study enrollment (i.e., patients who are moribund or comatose for any reason with little hope of recovery OR patients in danger of, or in hepatic stupor or coma) Hematopoietic - See Disease Characteristics - No signs or symptoms of uncontrolled bleeding Hepatic - Bilirubin no greater than 3 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN - AST and ALT no greater than 5 times ULN - No severe hepatic dysfunction Renal - Creatinine no greater than 3.4 mg/dL - Creatinine clearance at least 25 mL/min - No renal failure requiring hemodialysis or peritoneal dialysis Cardiovascular - No prior symptomatic arrhythmias - No clinically relevant bradycardia - No QTc interval prolongation - No uncorrected hypokalemia - No signs or symptoms of hypotension (systolic less than 90 mm Hg) Pulmonary - No signs or symptoms of respiratory insufficiency Other - Not pregnant or nursing - Fertile patients must use effective contraception - Able to swallow oral medication - No contraindication for oral drug intake - No condition likely to severely impair drug absorption - No prior immediate or accelerated reaction to penicillin, cephalosporin, or fluoroquinolone antibiotics - No known allergy or hypersensitivity to any antibiotics in this study or other quinolones - No signs or symptoms of severe dehydration - No signs or symptoms of shock - No other signs or symptoms at presentation that would necessitate IV supportive therapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Not specified Other - More than 4 days since prior antibacterial agents except for the following: - A single (oral or parenteral therapeutic) dose after initial diagnosic work-up and within the last 8 hours - Low-dose cotrimoxazole (i.e., no more than 480 mg daily or 960 mg 3 times per week) prophylaxis of Pneumocystis carinii pneumonia - More than 30 days since prior investigational drugs - No prior randomization in this study - No other concurrent antimicrobial agents - No class IA or class III antiarrhythmic drugs or other concurrent drugs that prolong the QTc interval
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WinfriedKern, , Klinikum der Albert - Ludwigs - Universitaet Freiburg
Klinikum der Albert - Ludwigs - Universitaet Freiburg *Recruiting*
Freiburg, , D-79106
Germany
Recruiting Contact Person 49-761-270-1818
Additional Information:
Study ID Numbers: CDR0000304631; EORTC-46001
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062231
Other Neutropenia Studies:
1. Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
2. Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
3. Alemtuzumab, Total-Body Irradiation, and Fludarabine Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
5. Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer
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Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
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