Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus aureus Nasal Colonization: Comparitive Analysis to Culture Screening Method.

Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus aureus Nasal Colonization: Comparitive Analysis to Culture Screening Method. - Rapid in vitro Detection of S. aureus Nasal Colonization

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30337

Enrollment

400

Registered

2006-11-30

Start date

2006-12-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre-operative patients undergoing non-emergent surgery

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for their non emergeny surgery.

Exclusion criteria

Exclusion criteria: Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.

Design outcomes

Primary

Measure	Time frame
This is a multi-center prospective, controlled, randomized, blinded clinical study to be conducted in the United States and the European Union. Clinical Sensitivity: Percent tested positive (positive test results) in a population of affected subjects with the specified agent / disease (i.e. How often the test is positive in subjects colonized with Staphylococcus aureus nasal carriage). Percent clinical sensitivity will be expressed mathematically as: Number of true-positive results / (Number of true-positive + false-negative results) X 100. Clinical Specificity: Percent tested negative (negative test results) in a population of subjects without the specified agent / disease (i.e. How often the test is negative in subjects not colonized with Staphylococcus aureus nasal colonization). Percent clinical specificity will be expressed mathematically as: Number of true-negative results / (Number of true-negative + false-positive results) X 100. Predictive Values: Probability that a positive result (positive predictive value, or PPV) accurately indicates the presence of a specific agent or disease or a negative result (negative predictive value, or NPV) accurately indicates the absence of a specific agent or disease. Percent positive predictive value will be expressed mathematically as: Number of true-positive results / (Number of true-positive + false-positive results) X 100. Percent negative predictive value will be expressed mathematically as: Number of true-negative results / (Number of true-negative + false-negative results) X 100.	—

Measure

Time frame

This is a multi-center prospective, controlled, randomized, blinded clinical study to be conducted in the United States and the European Union. Clinical Sensitivity: Percent tested positive (positive test results) in a population of affected subjects with the specified agent / disease (i.e. How often the test is positive in subjects colonized with Staphylococcus aureus nasal carriage). Percent clinical sensitivity will be expressed mathematically as: Number of true-positive results / (Number of true-positive + false-negative results) X 100. Clinical Specificity: Percent tested negative (negative test results) in a population of subjects without the specified agent / disease (i.e. How often the test is negative in subjects not colonized with Staphylococcus aureus nasal colonization). Percent clinical specificity will be expressed mathematically as: Number of true-negative results / (Number of true-negative + false-positive results) X 100. Predictive Values: Probability that a positive result (positive predictive value, or PPV) accurately indicates the presence of a specific agent or disease or a negative result (negative predictive value, or NPV) accurately indicates the absence of a specific agent or disease. Percent positive predictive value will be expressed mathematically as: Number of true-positive results / (Number of true-positive + false-positive results) X 100. Percent negative predictive value will be expressed mathematically as: Number of true-negative results / (Number of true-negative + false-negative results) X 100.

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Secondary

Measure	Time frame
The precence of S. aureus using traditional sreening method and the precence of MRSA.	—

Countries

Netherlands

Outcome results