MedPath

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.

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (20)

University College of London Hospitals

๐Ÿ‡ฌ๐Ÿ‡ง

London, England, United Kingdom

Great Ormond Street Hospital for Children

๐Ÿ‡ฌ๐Ÿ‡ง

London, England, United Kingdom

Addenbrooke's Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Cambridge, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Leeds, England, United Kingdom

Newcastle Upon Tyne Hospitals NHS Trust

๐Ÿ‡ฌ๐Ÿ‡ง

Newcastle-Upon-Tyne, England, United Kingdom

Bristol Royal Hospital for Children

๐Ÿ‡ฌ๐Ÿ‡ง

Bristol, England, United Kingdom

Our Lady's Hospital for Sick Children Crumlin

๐Ÿ‡ฎ๐Ÿ‡ช

Dublin, Ireland

Birmingham Children's Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Birmingham, England, United Kingdom

Leicester Royal Infirmary

๐Ÿ‡ฌ๐Ÿ‡ง

Leicester, England, United Kingdom

Saint Bartholomew's Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

London, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey

๐Ÿ‡ฌ๐Ÿ‡ง

Liverpool, England, United Kingdom

Royal Manchester Children's Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Manchester, England, United Kingdom

Queen's Medical Centre

๐Ÿ‡ฌ๐Ÿ‡ง

Nottingham, England, United Kingdom

Oxford Radcliffe Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Oxford, England, United Kingdom

Children's Hospital - Sheffield

๐Ÿ‡ฌ๐Ÿ‡ง

Sheffield, England, United Kingdom

Royal Belfast Hospital for Sick Children

๐Ÿ‡ฌ๐Ÿ‡ง

Belfast, Northern Ireland, United Kingdom

Royal Marsden - Surrey

๐Ÿ‡ฌ๐Ÿ‡ง

Sutton, England, United Kingdom

Southampton General Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Southampton, England, United Kingdom

Aberdeen Royal Infirmary

๐Ÿ‡ฌ๐Ÿ‡ง

Aberdeen, Scotland, United Kingdom

Royal Hospital for Sick Children

๐Ÿ‡ฌ๐Ÿ‡ง

Glasgow, Scotland, United Kingdom

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