Condition category
Haematological Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.vumc.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes