Clinical trial · Interventional
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)
NCT00062231CI-TRIAL-00008095terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Fever, Sweats, and Hot Flashes | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amoxicillin-clavulanate potassium | Drug | — | UNRESOLVED |
| ciprofloxacin | Drug | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| moxifloxacin hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
Secondary outcomes (4)
- measure
- Rate of complication as measured by Multinational Association for Supportive Care in Cancer (MASCC) criteria at the end of febrile neutropenic episode
- measure
- Time to discharge as measured by Logrank continuously until the end of febrile neutropenic episode
- measure
- Time to defervescence as measured by Logrank continuously until the end of febrile neutropenic episode
- measure
- Survival status as measured by Logrank at day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKern WV, Marchetti O, Drgona L, Akan H, Aoun M, Akova M, de Bock R, Paesmans M, Viscoli C, Calandra T. Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV. J Clin Oncol. 2013 Mar 20;31(9):1149-56. doi: 10.1200/JCO.2012.45.8109. Epub 2013 Jan 28. PMID 23358983