Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patient… (NCT00062231) | Clinical Trial Compass
TerminatedNot Applicable
Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
Stopped: low accrual
Belgium, France351 participantsStarted 2002-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.…
What they're measuring
1
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
Trial details
NCT IDNCT00062231
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC