Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024453
First received: September 13, 2001
Last updated: July 10, 2009
Last verified: June 2009
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Purpose
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 | Intervention |
|---|---|
|
Infection |
Biological: teicoplanin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 1360 |
| Study Start Date: | February 1999 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024453
Locations
| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| United Kingdom | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Bristol Royal Hospital for Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Great Ormond Street Hospital for Children | |
| London, England, United Kingdom, WC1N 3JH | |
| University College of London Hospitals | |
| London, England, United Kingdom, WIT 3AA | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Royal Manchester Children's Hospital | |
| Manchester, England, United Kingdom, M27 4HA | |
| Newcastle Upon Tyne Hospitals NHS Trust | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00024453 History of Changes |
| Other Study ID Numbers: | CDR0000068944, CCLG-SC-1999-01, EU-20124 |
| Study First Received: | September 13, 2001 |
| Last Updated: | July 10, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
infection |
Additional relevant MeSH terms:
|
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Teicoplanin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013