Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed 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).
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Suspected septicemia caused by coagulase-negative staphylococci
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Single or double lumen (no triple lumen) central venous catheter (CVC) (including subcutaneous ports) that can be flushed and aspirated
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Expected to remain in situ for at least 8 weeks
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No coagulase-negative septicemia associated with existing CVC within the past 12 weeks
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Our Lady's Hospital for Sick Children Crumlin | Dublin | Ireland | 12 | |
2 | Birmingham Children's Hospital | Birmingham | England | United Kingdom | B4 6NH |
3 | Bristol Royal Hospital for Children | Bristol | England | United Kingdom | BS2 8BJ |
4 | Addenbrooke's Hospital | Cambridge | England | United Kingdom | CB2 2QQ |
5 | Leeds Cancer Centre at St. James's University Hospital | Leeds | England | United Kingdom | LS9 7TF |
6 | Leicester Royal Infirmary | Leicester | England | United Kingdom | LE1 5WW |
7 | Royal Liverpool Children's Hospital, Alder Hey | Liverpool | England | United Kingdom | L12 2AP |
8 | Saint Bartholomew's Hospital | London | England | United Kingdom | EC1A 7BE |
9 | Great Ormond Street Hospital for Children | London | England | United Kingdom | WC1N 3JH |
10 | University College of London Hospitals | London | England | United Kingdom | WIT 3AA |
11 | Royal Manchester Children's Hospital | Manchester | England | United Kingdom | M27 4HA |
12 | Newcastle Upon Tyne Hospitals NHS Trust | Newcastle-Upon-Tyne | England | United Kingdom | NE7 7DN |
13 | Queen's Medical Centre | Nottingham | England | United Kingdom | NG7 2UH |
14 | Oxford Radcliffe Hospital | Oxford | England | United Kingdom | 0X3 9DU |
15 | Children's Hospital - Sheffield | Sheffield | England | United Kingdom | S10 2TH |
16 | Southampton General Hospital | Southampton | England | United Kingdom | SO16 6YD |
17 | Royal Marsden - Surrey | Sutton | England | United Kingdom | SM2 5PT |
18 | Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | United Kingdom | BT12 6BE |
19 | Aberdeen Royal Infirmary | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
20 | Royal Hospital for Sick Children | Edinburgh | Scotland | United Kingdom | EH9 1LF |
21 | Royal Hospital for Sick Children | Glasgow | Scotland | United Kingdom | G3 8SJ |
Sponsors and Collaborators
- Children's Cancer and Leukaemia Group
Investigators
- Study Chair: Barry Pizer, MD, Royal Liverpool Children's Hospital, Alder Hey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCLG-SC-1999-01
- CDR0000068944
- EU-20124