Infection Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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