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

NCT ID: NCT02640001

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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.).

Conditions

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Thoracic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Emilio Bouza

OTHER

Sponsor Role lead

Responsible Party

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Emilio Bouza

Head of Department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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HGU Gregorio Maranon

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 31668380 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30586363 (View on PubMed)

Other Identifiers

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MICRO.HGUGM-2015-080

Identifier Type: -

Identifier Source: org_study_id

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