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

Primary Purpose

Staphylococcal Infections

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
teicoplanin
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Infections focused on measuring teicoplanin

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2006
Last Updated
August 23, 2006
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00368498
Brief Title
A Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely
Official Title
A Randomized Single Blind Parallel Control Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
Keywords
teicoplanin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
teicoplanin
Primary Outcome Measure Information:
Title
the proportion of the trough level attaining 10 mg/L at different timing
Secondary Outcome Measure Information:
Title
the occurrence of adverse drug effects
Title
the correlation between the trough level and the patients' characteristics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shan-Chwen Chang, Ph.D.
Phone
886-2-23123456
Ext
5401
Email
sc4030@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan-Chwen Chang, Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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