PCR Technique to Identify Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus in Nasal and Respiratory Tract Samples

October 13, 2016 updated by: Emilio Bouza

Impact of the Introduction in a Heart Surgery ICU of a PCR Technique (Cepheid Xpert® SA Nasal Complete Assay) to Identify Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus in Nasal and Respiratory Tract Samples

In patients on mechanical ventilation, it is not known whether the identification of S. aureus in LRT samples improves the performance of its nasal detection.

To assess the MSSA or MRSA carrier status of patients requiring mechanical ventilation for more than 48 hours after major heart surgery: comparing the performance of the diagnostic technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients undergoing heart surgery require ventilation for more than 48 hours. These patients, placed on mechanical ventilation for a median of 7 days, will be followed weekly until their discharge from hospital. We estimate we will need 500 determinations.

Samples will be obtained according to usual clinical practice. Thus, rather than discarding a sample, it will be subjected to the two laboratory diagnostic techniques (conventional culture and the Xpert® assay). No patient will be subjected to any procedure outside that of routine clinical practice.

Patient with a tracheal tube in whom nasal and LRT secretions can be simultaneously obtained. Patients may also be included if LRT samples can be obtained via a different approach (tracheostomy, fibrobroncoscopy etc.).

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Hgu Gregorio Maranon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the Heart Surgery-ICU

Description

Inclusion Criteria:

  • Adults (≥ 18 years)
  • Signed Informed consent
  • Patient admitted to the HS-ICU before or after undergoing heart surgery
  • Patient on mechanical ventilation for >2 calendar days on the date of event (suspicion of LRT infection) ), taking the day of ventilator placement as day 1
  • Patient with a tracheal tube in whom nasal and LRT secretions can be simultaneously obtained. Patients may also be included if LRT samples can be obtained via a different approach (tracheostomy, fibrobroncoscopy etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staphylococcus aureus presence in nasal and respiratory tract samples
Time Frame: every 7 days from date of randomization, an average of two weeks
diagnostic technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.
every 7 days from date of randomization, an average of two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emilio Bouza

Collaborators

Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICRO.HGUGM-2015-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thoracic Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe