NCT01352936

Brief Summary

Staphylococcus aureus, the most virulent of the many staphylococcal species, has been recognized as one of the most important and lethal human bacterial pathogens. With the increased incidence of methicillin-resistant staphylococcus aureus (MRSA) infection in community and hospitalized patients, MRSA infections are associated with greater lengths of stay, higher mortality, and increased costs. Vancomycin and teicoplanin, are the two most commonly used glycopeptides and are the first-choice of treatment for MRSA infection. Vancomycin-induced nephrotoxicity is still a point of controversy. Teicoplanin is not known to have any nephrotoxicity. Acute kidney injury is a common complication of critical illness, which is reported in 5 to 7% of hospitalized patients. It is associated with significantly increased mortality, length of stay, and costs across a broad spectrum of conditions.

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
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

First QC Date

May 11, 2011

Last Update Submit

May 11, 2011

Conditions

Keywords

nephrotoxicityhospital costStaphylococcus aureusbacteremiavancomycinteicoplanin

Study Arms (2)

Experimental Group

Control Group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Staphylococcus aureus patients

You may qualify if:

  • Hospitalized patients who had been prescribed either vancomycin or teicoplanin for treating bloodstream infection caused by MRSA and had at least one serum creatinine data within 7 days after initiating glycopeptide therapy were recruited for this study.

You may not qualify if:

  • Patients who aged less than 15 years at admission were excluded. Those who switch treatment from vancomycin to teicoplanin or vise versa during the hospitalization were also excluded to avoid any possible carryover effect. Because the main objectives of this study were to compare the magnitude and consequences of nephrotoxicity associated with the two study medications, patients who underwent dialysis before the glycopeptides treatment were further excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Staphylococcal InfectionsBacteremia

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yuh-Mou Sue

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2011

First Posted

May 12, 2011

Study Start

January 1, 2011

Study Completion

December 1, 2011

Last Updated

May 12, 2011

Record last verified: 2011-05

Locations