Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter

Not Applicable

• Conditions: Infection

• Registration Number: NCT00024453
• Lead Sponsor: Children's Cancer and Leukaemia Group

Brief Summary

RATIONALE: Giving the antibiotic teicoplanin by infusion and allowing bacteria to be exposed to the antibiotic for a longer period of time may be effective in preventing or controlling septicemia.

PURPOSE: Randomized clinical trial to compare two different methods of giving teicoplanin in treating septicemia in patients who are receiving chemotherapy through a central venous catheter.

Detailed Description

OBJECTIVES:

* Compare the response and cure rate of coagulase-negative staphylococcal septicemia in patients receiving chemotherapy through a central venous catheter treated with 2 different schedules of teicoplanin.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and number of central venous catheter lumens (1 vs 2). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive teicoplanin IV bolus every 12 hours for 3 doses and then once daily for 5 doses (total of 7 days).

* Arm II: Patients receive teicoplanin IV over 2 hours and/or by antibiotic lock every 12 hours for 3 doses and then once daily for 5 doses (total of 7 days).

PROJECTED ACCRUAL: Approximately 490-1,360 patients will be accrued for this study within 2.2-6.2 years.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2009-06
• Primary Completion: 2009-12
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (20)

Our Lady's Hospital for Sick Children Crumlin; 🇮🇪 Dublin, Ireland

Birmingham Children's Hospital; 🇬🇧 Birmingham, England, United Kingdom

Bristol Royal Hospital for Children; 🇬🇧 Bristol, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey; 🇬🇧 Liverpool, England, United Kingdom

Saint Bartholomew's Hospital; 🇬🇧 London, England, United Kingdom

Great Ormond Street Hospital for Children; 🇬🇧 London, England, United Kingdom

University College of London Hospitals; 🇬🇧 London, England, United Kingdom

Scroll for more (10 remaining)