A randomised prospective double-blind, placebo controlled trial of prophylactic oral levofloxacin following chemotherapy for lymphoma and solid tumours
| ISRCTN | ISRCTN49693355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49693355 |
| ClinicalTrials.gov number | NCT00005590 |
| Secondary identifying numbers | SIGNIFICANT |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 28/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Multicentre randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | A randomised prospective double-blind, placebo controlled trial of prophylactic oral levofloxacin following chemotherapy for lymphoma and solid tumours |
| Study hypothesis | Added 07/08/09: Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if levofloxacin if effective in preventing infection.The aim of this trial is to determine the effectiveness of levofloxacin in preventing infection in patients receiving chemotherapy for solid tumors or lymphoma. As of 07/08/09 this record was extensively updated. All updates can be found under the relevant field with the above update date. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Breast, testis, lung (small cell), lymphoma (Hodgkins), lymphoma (non-Hodgkins) |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levofloxacin |
| Primary outcome measure | Added 07/08/09: Rate of clinical infection |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 03/08/1999 |
| Overall study end date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A total of 1,500 patients (750 per arm) will be accrued for this study within 3 years (added 07/08/09) |
| Participant 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. Normal serum creatinine or creatinine clearance >40 ml/min 6. Adequate contraceptive measures in place |
| Participant exclusion criteria | 1. Human Immunodeficiency Virus (HIV) positive 2. Pregnant or breast feeding 3. Epileptic 4. Planned granulocyte colony-stimulating factor (GCSF) or stem cell support 5. Currently taking antibacterial therapy or prophylaxis 6. History of adverse effects caused by fluoroquinolone agent 7. Previous participation in the Significant trial |
| Recruitment start date | 03/08/1999 |
| Recruitment end date | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/09/2005 | Yes | No | |
| Plain English results | 28/10/2021 | No | Yes |
Editorial Notes
28/10/2021: Cancer Research UK plain English results link added.
