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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640001
• Other study ID #: MICRO.HGUGM-2015-080
• Status: Completed
• Phase: N/A
• First received: October 19, 2015
• Last updated: October 13, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Staphylococcal Infections
• Thoracic Surgery

Locations

Country	Name	City	State
Spain	HGU Gregorio Maranon	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Emilio Bouza	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No