Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00005590
Protocol/serial number
SIGNIFICANT
Study information
Scientific title
Acronym
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
Not provided at time of registration
Study design
Multicentre randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
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
Phase
Not Specified
Drug names
Levofloxacin
Primary outcome measures
Added 07/08/09:
Rate of clinical infection
Secondary outcome measures
Not provided at time of registration
Overall trial start date
03/08/1999
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
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 type
Patient
Age group
Adult
Gender
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 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
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results on http://www.ncbi.nlm.nih.gov/pubmed/16148284
Publication citations
-
Results
Cullen M, Steven N, Billingham L, Gaunt C, Hastings M, Simmonds P, Stuart N, Rea D, Bower M, Fernando I, Huddart R, Gollins S, Stanley A, , Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas., N. Engl. J. Med., 2005, 353, 10, 988-998, doi: 10.1056/NEJMoa050078.