NCT00406549

Brief Summary

To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Geographic Reach
4 countries

11 active sites

Status
completed

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

First Submitted

Initial submission to the registry

November 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

First QC Date

November 30, 2006

Last Update Submit

September 30, 2024

Conditions

Staphylococcus Aureus

Keywords

Staphylococcus aureusNasal colonizationpre-surgical patientsSensitivitySpecificityNasal Staphylococcus aureus in pre-surgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 18 years of age or older, male or female and from any race or culture.
  • Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery.

You may not qualify if:

  • Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
  • Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hope Research Institute

Phoenix, Arizona, 85017, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Atlanta Institute for Medical Research

Decatur, Georgia, 30030, United States

Location

Northwestern Univesity

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital Bichat

Paris, 75877, France

Location

University of Muenster Hospital and Clinics

Münster, 48149, Germany

Location

Amphia Hospital

Breda, 4818CK, Netherlands

Location

MeSH Terms

Conditions

Staphylococcal InfectionsHypersensitivity

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsImmune System Diseases

Study Officials

  • Steve Gordon, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

December 1, 2006

Study Completion

March 1, 2007

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

NL(1)FR(1)US(8)DE(1)