| Source of record | UK Trials |
| ISRCTN | ISRCTN49693355 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | SIGNIFICANT |
| Public title | A randomised prospective double-blind, placebo controlled trial of prophylactic oral levofloxacin following chemotherapy for lymphoma and solid tumours |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Breast, testis, lung (small cell), lymphoma (Hodgkins), lymphoma (non-Hodgkins) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 03/08/1999 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN49693355 |
| Date last extracted from ISRCTN register | 17/04/2008 |
