The Use of Teicoplanin in the Treatment of Septicaemia Caused by Coagulase-Negative Staphylococci - A Randomized Study Comparing Bolus Injection With Infused and/or Line-Locked Teicoplanin
N/A
N/A
Both
Infection
Trial Information
The Use of Teicoplanin in the Treatment of Septicaemia Caused by Coagulase-Negative Staphylococci - A Randomized Study Comparing Bolus Injection With Infused and/or Line-Locked Teicoplanin
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Barry Pizer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Liverpool Children's Hospital, Alder Hey
Authority:
United States: Federal Government
Study ID:
CDR0000068944
NCT ID:
NCT00024453
Start Date:
February 1999
Completion Date:
Related Keywords:
- Infection
- infection
- Sepsis
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