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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Emilio Bouza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.).

Conditions

• Thoracic Surgery

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-12-28
• Last updated: 2016-10-14

Locations

1 site across 1 country: Spain