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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00368498
Other study ID # 950115
Secondary ID
Status Recruiting
Phase Phase 4
First received August 23, 2006
Last updated August 23, 2006
Start date June 2006
Est. completion date December 2007

Study information

Verified date August 2006
Source National Taiwan University Hospital
Contact Shan-Chwen Chang, Ph.D.
Phone 886-2-23123456
Email sc4030@ha.mc.ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Patients over 16 years of age who have blood culture-proven MRSA bacteremia and did not receive teicoplanin or vancomycin in the previous one month are enrolled.

Exclusion Criteria:

- Those who are allergic to teicoplanin or who have the need to use higher doses, 12 mg/kg/dose, such as endocarditis, osteomyelitis, septic arthritis and burn patients, are excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
teicoplanin


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary the proportion of the trough level attaining 10 mg/L at different timing
Secondary the occurrence of adverse drug effects
Secondary the correlation between the trough level and the patients' characteristics
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