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
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
December 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedOctober 14, 2016
July 1, 2015
9 months
October 19, 2015
October 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Staphylococcus aureus presence in nasal and respiratory tract samples
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
Eligibility Criteria
All patients admitted to the Heart Surgery-ICU
You may qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emilio Bouzalead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (1)
HGU Gregorio Maranon
Madrid, Madrid, 28007, Spain
Related Publications (2)
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.
PMID: 31668380DERIVEDBouza 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.
PMID: 30586363DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
October 19, 2015
First Posted
December 28, 2015
Study Start
July 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
October 14, 2016
Record last verified: 2015-07