Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368498
Status:
UNKNOWN
Last Update Posted:
2006-08-24
First Post:
2006-08-23
Brief Title:
A Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Randomized Single Blind Parallel Control Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
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:
The purpose of this study is to determine whether the standard dosage of teicoplanin is adequate to produce timely the trough level 10 mgL which is considered to be effective in the treatment of methicillin-resistant Staphyllococcus aureus MRSA bacteremia
Detailed Description:
In our hospital the minimum inhibitory concentration of 100 MRSA isolates in 2003 for teicoplanin is 2 mgL Due to its time-dependant bacteriocidal effect the trough level should exceed 10 mgL particularly in the elderly for MRSA bacteremia However it is known that standard dosage of teicoplanin often produces inadequate serum trough levels and MRSA infections may recurred Therefore to evaluate the loading dose required to achieve therapeutic concentration timely we compare the trough levels between those given standard dose 6 mgKg and those given increasing loading dose 12 mgKg We also monitor the occurrence of adverse drug effects and clinical response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None