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

Not Applicable

Completed

• Conditions: Breast, testis, lung (small cell), lymphoma (Hodgkins), lymphoma (non-Hodgkins); Cancer; Complications of procedures, not elsewhere classified

• Registration Number: ISRCTN49693355
• Lead Sponsor: Cancer Research UK (CRUK) (UK)

Brief Summary

2005 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16148284 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-01
• Study Completion: 2003-12-31
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Added 07/08/09:<br> Rate of clinical infection<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration