Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
07/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

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

  1. 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.

Additional files

Editorial Notes