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| Sponsored by: |
Children's Cancer and Leukaemia Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024453 |
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: | Supportive Care, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 1360 |
| Study Start Date: | February 1999 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Single or double lumen (no triple lumen) central venous catheter (CVC) (including subcutaneous ports) that can be flushed and aspirated
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | Recruiting |
| Dublin, Ireland, 12 | |
| Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie | |
| United Kingdom, England | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Denise Williams, MD 44-1223-216-878 | |
| Birmingham Children's Hospital | Recruiting |
| Birmingham, England, United Kingdom, B4 6NH | |
| Contact: Bruce Morland, MD 44-121-333-8233 bruce.morland@bch.nhs.uk | |
| Bristol Royal Hospital for Children | Recruiting |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Contact: Annabel B.M. Foot 44-117-342-8520 | |
| Children's Hospital - Sheffield | Recruiting |
| Sheffield, England, United Kingdom, S10 2TH | |
| Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
| Oxford Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Contact: Kate Wheeler, MD 44-186-522-1066 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk | |
| Leicester Royal Infirmary | Recruiting |
| Leicester, England, United Kingdom, LE1 5WW | |
| Contact: Rosemary S. Shannon, MD 44-116-254-1414 | |
| Newcastle Upon Tyne Hospitals NHS Trust | Recruiting |
| Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
| Contact: Andrew David J. Pearson, MD, FRCP, DCh 44-191-232-5131 ext. 24101 | |
| Great Ormond Street Hospital for Children | Recruiting |
| London, England, United Kingdom, WC1N 3JH | |
| Contact: Penelope Brock, MD, PhD 44-20-829-8832 Brockp@gosh.nhs.uk | |
| Queen's Medical Centre | Recruiting |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Contact: David A. Walker 44-115-924-9924 ext 61727 david.walker@nottingham.ac.uk | |
| Royal Liverpool Children's Hospital, Alder Hey | Recruiting |
| Liverpool, England, United Kingdom, L12 2AP | |
| Contact: Heather P. McDowell, MD 44-151-293-3679 | |
| Royal Manchester Children's Hospital | Recruiting |
| Manchester, England, United Kingdom, M27 4HA | |
| Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Kathy Pritchard-Jones, MD 44-20-8661-3452 ext 3498 | |
| Saint Bartholomew's Hospital | Recruiting |
| London, England, United Kingdom, EC1A 7BE | |
| Contact: Judith E. Kingston, MD 44-20-7943-1339 j.e.kingston@qmul.ac.uk | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |
| University College of London Hospitals | Recruiting |
| London, England, United Kingdom, WIT 3AA | |
| Contact: Maria Michelagnoli, MD 44-20-7380-9950 maria.michelagnoli@uclh.org | |
| United Kingdom, Northern Ireland | |
| Royal Belfast Hospital for Sick Children | Recruiting |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: D.J. King, MD 44-84-5456-6000 derek.king@arh.gampian.scot.nhs.uk | |
| Royal Hospital for Sick Children | Recruiting |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Contact: E.M. Simpson 44-141-201-0000 | |
| Royal Hospital for Sick Children | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Contact: W. Hamish Wallace, MD 44-131-536-0426 | |
| Study Chair: | Barry Pizer, MD | Royal Liverpool Children's Hospital, Alder Hey |
More Information
| Study ID Numbers: | CDR0000068944, CCLG-SC-1999-01, EU-20124 |
| Study First Received: | September 13, 2001 |
| Last Updated: | July 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00024453 History of Changes |
| Health Authority: | Unspecified |
|
infection |
|
Coagulase Systemic Inflammatory Response Syndrome Anti-Bacterial Agents |
Sepsis Teicoplanin Inflammation |
|
Systemic Inflammatory Response Syndrome Anti-Infective Agents Anti-Bacterial Agents Sepsis Teicoplanin |
Pathologic Processes Therapeutic Uses Infection Pharmacologic Actions Inflammation |
