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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
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Status
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Sponsor
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Protocol IDs
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No phase specified
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Supportive care
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Active
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2 months and over
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Other
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CCLG-SC-1999-01
EU-20124, NCT00024453
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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 Chemotherapy - See Disease Characteristics
Endocrine therapy Radiotherapy Surgery Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: - Creatinine clearance at least 60 mL/min
Expected Enrollment 1360Approximately 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 | | | |
Trial Sites
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| Ireland |
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Dublin |
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| | | | Our Lady's Hospital for Sick Children Crumlin |
| | | Fin Breatnach, MD, FRCPE | |
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fin.breatnach@olhsc.ie |
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| United Kingdom |
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| England |
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Birmingham |
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| | | | | Birmingham Children's Hospital |
| | | Bruce Morland, MD | |
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bruce.morland@bch.nhs.uk |
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Bristol |
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| | | Bristol Royal Hospital for Children |
| | | Annabel B.M. Foot | |
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Cambridge |
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| | | Addenbrooke's Hospital |
| | | Denise Williams, MD | |
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Leeds |
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| | | Leeds Cancer Centre at St. James's University Hospital |
| | | Adam Glaser, MD | |
| | Email:
adam.glaser@leedsth.nhs.uk |
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Leicester |
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| | | Leicester Royal Infirmary |
| | | Rosemary Shannon, MD | |
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Liverpool |
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| | | Royal Liverpool Children's Hospital, Alder Hey |
| | | Heather McDowell, MD | |
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London |
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| | | Great Ormond Street Hospital for Children |
| | | Penelope Brock, MD, PhD | |
| | Email:
Brockp@gosh.nhs.uk |
| | | Saint Bartholomew's Hospital |
| | | Judith Kingston, MD | |
| | Email:
j.e.kingston@qmul.ac.uk |
| | | University College of London Hospitals |
| | | Maria Michelagnoli, MD | |
| | Email:
maria.michelagnoli@uclh.org |
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Manchester |
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| | | Royal Manchester Children's Hospital |
| | | Bernadette Brennan, MD | |
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bernadette.brennan@cmmc.nhs.uk |
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Newcastle-Upon-Tyne |
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| | | Newcastle Upon Tyne Hospitals NHS Trust |
| | | Andrew David J. Pearson, MD, FRCP, DCh | | Ph: | 44-191-232-5131 ext. 24101 | | |
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Nottingham |
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| | | Queen's Medical Centre |
| | | David Walker | |
| | Email:
david.walker@nottingham.ac.uk |
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Oxford |
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| | | Oxford Radcliffe Hospital |
| | | Kate Wheeler, MD | |
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Sheffield |
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| | | Children's Hospital - Sheffield |
| | | Mary Gerrard, BSc, MBChB, FRCP, FRCPCH | |
| | Email:
mary.gerrard@sch.nhs.uk |
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Southampton |
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| | | Southampton General Hospital |
| | | Janice Kohler, MD, FRCP | |
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Sutton |
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| | | Royal Marsden - Surrey |
| | | Kathy Pritchard-Jones, MD | |
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| Northern Ireland |
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Belfast |
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| | | | Royal Belfast Hospital for Sick Children |
| | | Anthony McCarthy, MD | |
| | Email:
anthonymcarthy@royalhospital.n.i.nhs.uk |
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| Scotland |
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Aberdeen |
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| | | | Aberdeen Royal Infirmary |
| | | D.J. King, MD | |
| | Email:
derek.king@arh.gampian.scot.nhs.uk |
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Edinburgh |
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| | | Royal Hospital for Sick Children |
| | | W. Hamish Wallace, MD | |
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Glasgow |
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| | | Royal Hospital for Sick Children |
| | | E.M. Simpson | |
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| 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 | | 2008-04-27 |
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.  Back to Top |
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