evofloxacin versus ciprofloxacin combined with penicillin for the prevention of bacterial infections in neutropenic patients with haematological malignancies: a single centre, randomised clinical trial

Vrije University Medical Centre (VUMC) (The Netherlands)0 个研究点目标入组 245 人开始时间: 2005年12月20日最近更新: 2015年1月13日

适应症

试验速览

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•1. Men and women, aged 18 - 75 years
•2. Patients admitted to the department of hematology for remission induction chemotherapy for acute leukaemia and other haematological 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, within 48 hours prior to enrolment
•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: aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), lacate dehydrogenase (LDH), or alkaline phosphatase (AP), and serum bilirubin over 50 micromol/L
•9. Creatinine clearance less than 15 ml/min
•10. Patients with acquired immune deficiency syndrome (AIDS), AIDS-related complex (ARC) or known to be human immunodeficiency virus (HIV) positive
•11. Pregnancy or lactation
•12. World Health Organization (WHO) condition grade IV
•13 .A history of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation or other emotional or intellectual problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements
•14. Participation in other studies involving investigational products within one month prior to entry into this study or concomitantly with this study

发起方

Vrije University Medical Centre (VUMC) (The Netherlands)