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Status unknownNCT00368498Updated Aug 24, 2006

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

A Phase 4 interventional study of teicoplanin in Staphylococcal Infections, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2006-08-24.

Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
16 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Staphylococcal Infections

Keywords

  • teicoplanin
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In context

Staphylococcal Infections

273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
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

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
20 participants

Interventions

  • Drugteicoplanin
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. the occurrence of adverse drug effects

  2. the correlation between the trough level and the patients' characteristics

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00368498
Lead sponsor
National Taiwan University Hospital
First posted
Aug 24, 2006
Start date
Jun 2006
Completion
Dec 2007
Last update
Aug 24, 2006

Study contacts

Shan-Chwen Chang, Ph.D.
Contact
sc4030@ha.mc.ntu.edu.tw
886-2-23123456 ext. 5401
Shan-Chwen Chang, Ph.D.
principal investigator · National Taiwan University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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