Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024453
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-09-13
Brief Title:
Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Use of Teicoplanin in the Treatment of Septicaemia Caused by Coagulase-Negative Staphylococci - A Randomized Study Comparing Bolus Injection With Infused andor Line-Locked Teicoplanin
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Arm II Patients receive teicoplanin IV over 2 hours andor by antibiotic lock every 12 hours for 3 doses and then once daily for 5 doses total of 7 days
PROJECTED ACCRUAL Approximately 490-1360 patients will be accrued for this study within 22-62 years
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 andor by antibiotic lock every 12 hours for 3 doses and then once daily for 5 doses total of 7 days
PROJECTED ACCRUAL Approximately 490-1360 patients will be accrued for this study within 22-62 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20124 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068944 | REGISTRY | None | None |