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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: August 23, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
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.

Condition Intervention Phase
Staphylococcal Infections Drug: teicoplanin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized Single Blind Parallel Control Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 20
Study Start Date: June 2006
Estimated Study Completion Date: December 2007
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.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00368498

Contact: Shan-Chwen Chang, Ph.D. 886-2-23123456 ext 5401

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Shan-Chwen Chang, Ph.D. National Taiwan University Hospital
  More Information Identifier: NCT00368498     History of Changes
Other Study ID Numbers: 950115
Study First Received: August 23, 2006
Last Updated: August 23, 2006

Keywords provided by National Taiwan University Hospital:

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 25, 2017