Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00024453|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
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|
|Infection||Biological: teicoplanin||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1360 participants|
|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|
|Study Start Date :||February 1999|
|Estimated Primary Completion Date :||December 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024453
|Our Lady's Hospital for Sick Children Crumlin|
|Dublin, Ireland, 12|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Bristol Royal Hospital for Children|
|Bristol, England, United Kingdom, BS2 8BJ|
|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|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Great Ormond Street Hospital for Children|
|London, England, United Kingdom, WC1N 3JH|
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|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|
|Study Chair:||Barry Pizer, MD||Royal Liverpool Children's Hospital, Alder Hey|