Clinical trial: Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer (NCT00062231)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Contradiction