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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00368498
First received: August 23, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368498

Contacts
Contact: Shan-Chwen Chang, Ph.D. 886-2-23123456 ext 5401 sc4030@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shan-Chwen Chang, Ph.D. National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00368498     History of Changes
Other Study ID Numbers: 950115
Study First Received: August 23, 2006
Last Updated: August 23, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
teicoplanin

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014