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 of protocol

Not provided at time of registration

Contact information

Dr - -
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 objectives	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
Health condition(s) or problem(s) studied	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
Completion 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)
Key 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
Key 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
Date of first enrolment	03/08/1999
Date of final enrolment	31/12/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone	+44 (0)207 317 5186
Email	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

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.