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
Protocol serial number NTR341
Sponsor Vrije University Medical Centre (VUMC) (The Netherlands)
Funder Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Haematology
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

Vrije University Medical Centre
Department of Haematology
BR 240, P.O. Box 7057
Amsterdam
1007 MB
Netherlands

+31 (0)20 444 2604
gj.timmers@vumc.nl

Study information

Primary study designInterventional
Study designRandomised active controlled parallel group trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesLevofloxacin 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) studiedHemato-oncological patients, neutropenia
Intervention1. 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Levofloxacin, ciprofloxacin, penicillin
Primary outcome measure(s)

The number of microbiologically documented bacterial infections will be established

Key secondary outcome measure(s)

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

Completion date01/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexAll
Target sample size at registration245
Key inclusion criteria1. 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 criteria1. 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 enrolment15/01/2002
Date of final enrolment01/09/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan
BMC - Part of Springer Nature Springer Nature