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ISRCTN
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ISRCTN49693355
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ClinicalTrials.gov identifier
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NCT00005590
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Public title
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A randomised prospective double-blind, placebo controlled trial of prophylactic oral levofloxacin following chemotherapy for lymphoma and solid tumours
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Scientific title
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Acronym
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N/A
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Serial number at source
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SIGNIFICANT
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast, testis, lung (small cell), lymphoma (Hodgkins), lymphoma (non-Hodgkins)
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Participants - inclusion criteria
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1. Adult who has given informed consent
2. Solid tumour or lymphoma
3. First cycle of anti-neoplastic chemotherapy
4. Anticipated neutrophil nadir <0.5 x 10^9/l
5. Not Human Immunodeficiency Virus (HIV) positive
6. Not pregnant or breast feeding
7. Not epileptic
8. Normal serum creatinine or creatinine clearance >40 ml/min
9. No planned granulocyte colony-stimulating factor (GCSF) or stem cell support
10. Not currently taking antibacterial therapy or prophylaxis
11. No history of adverse effects caused by fluoroquinolone agent
12. No previous participation in the Significant trial
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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03/08/1999
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Anticipated end date
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31/12/2003
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1 x 500 mg tablet of placebo or levofloxacin/day for seven days. Start on day eight for 21-day cycles or on day 15 for 28-day cycles.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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2005 results on http://www.ncbi.nlm.nih.gov/pubmed/16148284
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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13/05/2008
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Date ISRCTN assigned
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01/07/2001
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