Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter

Children's Cancer and Leukaemia Group

Status: Unknown

Conditions: Infection

Treatments: Biological: teicoplanin

Study type: Interventional

Funder types: Other

Identifiers

NCT00024453

CCLG-SC-1999-01

CDR0000068944 (Registry Identifier)

EU-20124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,360 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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