This trial is active, not recruiting.

Condition infection
Treatment teicoplanin
Sponsor Children's Cancer and Leukaemia Group
Start date February 1999
End date December 2009
Trial size 1360 participants
Trial identifier NCT00024453, CCLG-SC-1999-01, CDR0000068944, EU-20124


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose supportive care

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).