A randomised prospective double-blind, placebo controlled trial of prophylactic oral levofloxacin following chemotherapy for lymphoma and solid tumours

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Multicentre randomised double blind placebo controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Levofloxacin
Primary outcome measure(s)	Added 07/08/09: Rate of clinical infection
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1500
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

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

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

28/10/2021: Cancer Research UK plain English results link added.