Clinical Trials Directory

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UnknownNCT00368498

A Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely

A Randomized Single Blind Parallel Control Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
20 (planned)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether the standard dosage of teicoplanin is adequate to produce timely the trough level \> 10 mg/L, 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 mg/L. Due to its time-dependant bacteriocidal effect, the trough level should exceed 10 mg/L, 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 mg/Kg) and those given increasing loading dose (12 mg/Kg). We also monitor the occurrence of adverse drug effects and clinical response.

Conditions

Interventions

TypeNameDescription
DRUGteicoplanin

Timeline

Start date
2006-06-01
Completion
2007-12-01
First posted
2006-08-24
Last updated
2006-08-24

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT00368498. Inclusion in this directory is not an endorsement.