evofloxacin versus ciprofloxacin combined with penicillin for the prevention of bacterial infections in neutropenic patients with hematological malignancies: a single center, randomized clinical trial.
Completed
- Conditions
- eutropenic patients with hematological malignancies.
- Registration Number
- NL-OMON21952
- Lead Sponsor
- Dept. of Hematology VUmc, Amsterdam, the Netherlands
- Brief Summary
Clin Microbiol Infect. 2007 May;13(5):497-503. Epub 2007 Jan 30.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 245
Inclusion Criteria
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;
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;
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 emperical broa spectrum antibiotic therapy, time to infection, the number of antibiotocs/antibiotic days will be established; <br /><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><br />3. Patients compliance and tolerability of the prophylactic regimen will be established from data of the patient questionnaire.