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

Phase 4

• Conditions: Staphylococcal Infections

• Registration Number: NCT00368498
• Lead Sponsor: National Taiwan University Hospital

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Status Verified: 2006-08
• Study First Submitted: 2006-08-23
• Study First Submitted QC: 2006-08-23
• Last Update Submitted: 2006-08-23
• Study First Posted: 2006-08-24
• Last Update Posted: 2006-08-24
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the proportion of the trough level attaining 10 mg/L at different timing

Secondary Outcome Measures

Name	Time	Method
the occurrence of adverse drug effects
the correlation between the trough level and the patients' characteristics

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan