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Levofloxacin versus ciprofloxacin combined with penicillin for the prevention of bacterial infections in neutropenic patients with hematological malignancies: a single center, randomized clinical trial.


- candidate number1549
- NTR NumberNTR341
- ISRCTNISRCTN68044984
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleLevofloxacin versus ciprofloxacin combined with penicillin for the prevention of bacterial infections in neutropenic patients with hematological malignancies: a single center, randomized clinical trial.
- Scientific TitleLevofloxacin versus ciprofloxacin combined with penicillin for the prevention of bacterial infections in neutropenic patients with hematological malignancies: a single center, randomized clinical trial.
- ACRONYMN/A
- hypothesisLevofloxacin and the standard propfylaxis (ciprofloxacin and penicillin) are equivalent.
- Healt Condition(s) or Problem(s) studiedHemato-oncological patients, Neutropenia
- Inclusion criteria1. 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;
3. An anticipated granulocytopenic period of at least 10 days;
4. Written informed consent.
- 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, within48 hours prior to enrollment;
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:
ASAT,ALAT,lacate dehydrogenase (LDH), or alkaline phosphatase (AP), and serum bilirubin over 50 micromol/L;
9. A creatinin clearance <15ml/min;
10. Patients with AIDS, ARC or known to be HIV positive;
11. Pregnacy or lactation;
12. WHO condition grade IV;
13. A history of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation or other emational or intellectual problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirments;
14. Participation in other studies involving investigational products within one month prior to entry into this study or concommitantly with this study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jan-2002
- planned closingdate1-sep-2005
- Target number of participants245
- InterventionsConventional arm:
ciprofloxacin 500mg 2x/day and feniticilline 250mg 4x/day
Experimental arm:
levofloxacine 500mg 1x/day.
Both arms will be given from start chemotherapy until ANC recovery (>0,5x109).
- Primary outcomeThe number of microbiologically documented bacterial infections will be established.
- Secondary outcome1. The number of patients requiring initiation of emperical broa spectrum antibiotic therapy, time to infection, the number of antibiotocs/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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M.E. Leidekker
- CONTACT for SCIENTIFIC QUERIES G.J. Timmers
- Sponsor/Initiator VU University Medical Center, Department of Hematology
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsClin Microbiol Infect. 2007 May;13(5):497-503. Epub 2007 Jan 30.
- Brief summaryOpen label, single center, randomized clinical trial to evaluate the effectiveness of levofloxacin as prophylactic antibiotic regimen versus ciprofloxacin combined with penicilline in neutropenic patients with hematological malignancies.
- Main changes (audit trail)
- RECORD12-sep-2005 - 11-sep-2008


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