NCT00368498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 24, 2006

Status Verified

August 1, 2006

First QC Date

August 23, 2006

Last Update Submit

August 23, 2006

Conditions

Staphylococcal Infections

Keywords

teicoplanin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • the occurrence of adverse drug effects

  • the correlation between the trough level and the patients' characteristics

Interventions

teicoplaninDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Teicoplanin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipoglycopeptidesGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Shan-Chwen Chang, Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan-Chwen Chang, Ph.D.

CONTACT

886-2-23123456sc4030@ha.mc.ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2007

Last Updated

August 24, 2006

Record last verified: 2006-08

Locations

TW(1)