Contact information
Type
Scientific
Primary contact
Mr G.J. Timmers
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR341
Study information
Scientific title
Acronym
Study hypothesis
Levofloxacin and the standard prophylaxis (ciprofloxacin and penicillin) are equivalent.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/01/2002
Overall trial end date
01/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
245
Participant 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
Recruitment start date
15/01/2002
Recruitment end date
01/09/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Haematology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Haematology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list