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

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ClinicalTrials.gov Identifier: NCT00368498
Recruitment Status : Unknown
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 24, 2006
Last Update Posted : August 24, 2006
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Staphylococcal Infections Drug: teicoplanin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : June 2006
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. the proportion of the trough level attaining 10 mg/L at different timing

Secondary Outcome Measures :
  1. the occurrence of adverse drug effects
  2. the correlation between the trough level and the patients' characteristics


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00368498     History of Changes
Other Study ID Numbers: 950115
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: August 24, 2006
Last Verified: August 2006

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