Levofloxacin versus ciprofloxacin combined with penicillin for the prevention of bacterial infections in neutropenic patients with hematological malignancies: a single center, randomized clinical trial.

1. Men and women, aged 18-75 year;

2. Patients admitted to the department of hematology for remission induction chemotherapy for acute leukaemia and other hematological malignancies;

3. An anticipated granulocytopenic period of at least 10 days;

4. Written informed consent.

1. A previous history of allergy to or known hypersensitivity to quinolone derivates or penicillin antibiotics;

2. Fever within the preceding 24 hours;

3. Infection requiring treatment at entry;

4. Treatment with any antibiotics, within48 hours prior to enrollment;

5. Therapy with any other investigational drug during the preceding month;

6. Concomitant experimental chemotherapy;

7. Concomitant antibiotic therapy other than mentioned in the protocol;

8. Known hepatic impairment as determined by elevation of any liver function test greater than three times the upper limit of normal, including:
ASAT,ALAT,lacate dehydrogenase (LDH), or alkaline phosphatase (AP), and serum bilirubin over 50 micromol/L;

9. A creatinin clearance <15ml/min;

10. Patients with AIDS, ARC or known to be HIV positive;

11. Pregnacy or lactation;

12. WHO condition grade IV;

13. A history of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation or other emational or intellectual problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirments;

14. Participation in other studies involving investigational products within one month prior to entry into this study or concommitantly with this study.