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

Completed

• Conditions: Hemato-oncological patients, neutropenia; Haematological Disorders; Agranulocytosis

• Registration Number: ISRCTN68044984
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of microbiologically documented bacterial infections will be established<br>

Secondary Outcome Measures

Name	Time	Method
1. The number of patients requiring initiation of empirical broad spectrum antibiotic therapy, time to infection, the number of antibiotics/antibiotic days will be established<br>2. The average values of these endpoints will be compared between the two treatment-groups by means of Wilcoxon's Rank-sum test<br>3. Patients compliance and tolerability of the prophylactic regimen will be established from data of the patient questionnaire