Levofloxacin versus ciprofloxacin combined with penicillin for the prevention of bacterial infections in neutropenic patients with haematological malignancies: a single centre, randomised clinical trial
ISRCTN | ISRCTN68044984 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN68044984 |
Secondary identifying numbers | NTR341 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 19/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr G.J. Timmers
Scientific
Scientific
Vrije University Medical Centre
Department of Haematology
BR 240, P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Phone | +31 (0)20 444 2604 |
---|---|
gj.timmers@vumc.nl |
Study information
Study design | Randomised active controlled parallel group trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Levofloxacin and the standard prophylaxis (ciprofloxacin and penicillin) are equivalent. |
Ethics approval(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Hemato-oncological patients, neutropenia |
Intervention | 1. Conventional arm: ciprofloxacin 500 mg 2 x day and feniticilline 250 mg 4 x day 2. Experimental arm: levofloxacine 500 mg 1 x day Both arms will be given from start chemotherapy until ANC recovery (greater than 0.5 x 10^9). |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Levofloxacin, ciprofloxacin, penicillin |
Primary outcome measure | The number of microbiologically documented bacterial infections will be established |
Secondary outcome measures | 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 2. The average values of these endpoints will be compared between the two treatment-groups by means of Wilcoxon's Rank-sum test 3. Patients compliance and tolerability of the prophylactic regimen will be established from data of the patient questionnaire |
Overall study start date | 15/01/2002 |
Completion date | 01/09/2005 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | 245 |
Key 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 |
Key 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 |
Date of first enrolment | 15/01/2002 |
Date of final enrolment | 01/09/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Haematology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Website | http://www.vumc.nl |
---|---|
https://ror.org/00q6h8f30 |
Funders
Funder type
Hospital/treatment centre
Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Haematology
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |