Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter
NCT ID: NCT00024453
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1360 participants
INTERVENTIONAL
1999-02-28
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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teicoplanin
Eligibility Criteria
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Inclusion Criteria
* Suspected septicemia caused by coagulase-negative staphylococci
* Single or double lumen (no triple lumen) central venous catheter (CVC) (including subcutaneous ports) that can be flushed and aspirated
* Expected to remain in situ for at least 8 weeks
* No coagulase-negative septicemia associated with existing CVC within the past 12 weeks
* Receiving chemotherapy for neoplastic condition, aplastic anemia, Fanconi's anemia, Langerhans' cell histiocytosis, or myelodysplasia
PATIENT CHARACTERISTICS:
Age:
* 2 months and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Creatinine clearance at least 60 mL/min
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Barry Pizer, MD
Role: STUDY_CHAIR
Royal Liverpool Children's Hospital, Alder Hey
Locations
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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
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CDR0000068944
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20124
Identifier Type: -
Identifier Source: secondary_id
CCLG-SC-1999-01
Identifier Type: -
Identifier Source: org_study_id