- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02640001
PCR Technique to Identify Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus in Nasal and Respiratory Tract Samples
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28007
- Hgu Gregorio Maranon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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diagnostic technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.
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every 7 days from date of randomization, an average of two weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Bouza E, Burillo A, de Egea V, Hortal J, Barrio JM, Vicente T, Munoz P, Perez-Granda MJ. Colonization of the nasal airways by Staphylococcus aureus on admission to a major heart surgery operating room: A real-world experience. Enferm Infecc Microbiol Clin (Engl Ed). 2020 Dec;38(10):466-470. doi: 10.1016/j.eimc.2019.07.013. Epub 2019 Oct 23. English, Spanish.
- Bouza E, Burillo A, Munoz P, Valerio M, Barrio JM, Hortal J, Cuerpo G, Perez-Granda MJ. Do lower respiratory tract samples contribute to the assessment of carriage of Staphylococcus aureus in patients undergoing mechanical ventilation after major heart surgery? PLoS One. 2018 Dec 26;13(12):e0207854. doi: 10.1371/journal.pone.0207854. eCollection 2018.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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