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Randomized Study of Teicoplanin for Coagulase-Negative Staphylococcal Septicemia in Patients Receiving Chemotherapy Through a Central Venous Catheter

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Supportive care Closed 2 months and over Other CCLG-SC-1999-01
EU-20124, NCT00024453

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

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

Expected Enrollment

1360

Approximately 490-1,360 patients will be accrued for this study within 2.2-6.2 years.

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).

Trial Contact Information

Trial Lead Organizations

Children's Cancer and Leukaemia Group

Barry Pizer, MD, Protocol chair
Ph: 44-151-252-5294
Email: bpizer@liv.ac.uk

Registry 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

Trial Start Date		1999-02-01

Trial Completion Date		2009-12-31 (estimated)

Registered in ClinicalTrials.gov		NCT00024453

Date Submitted to PDQ		2001-07-19

Information Last Verified		2009-06-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.