Decolonization of patients carrying S. aureus before cardiac surgery: study of the risk factors associated with failure

Decolonization of patients carrying S. aureus before cardiac surgery: study of the risk factors associated with failure - STAdécol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001505-90-FR

Enrollment

600

Registered

2018-06-28

Start date

2018-10-01

Completion date

Unknown

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decolonization of S. aureus nasal carriers before cardiac surgery MedDRA version: 20.0 Level: LLT Classification code 10075981 Term: Staphylococcus aureus infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10048935 Term: Open heart surgery System Organ Class: 100000004865

Interventions

Trade Name: bactroban Product Name: mupirocine Pharmaceutical Form: Nasal ointment Trade Name: hextril Product Name: héxétidine Pharmaceutical Form: Mouthwash Trade Name: hibiscrub Product Name: dig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients - Scheduled cardiac surgery at the University hospital of Saint-Etienne - primary surgery - signature of consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Surgical site infection - Surgery in an emergency and semi-emergency context - patient under guardianship - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify the main risk factors for failure of pre-operative decolonization of S. aureus by antimicrobials in patients undergoing scheduled cardiac surgery.;Secondary Objective: 1. Determine the prevalence of nasal carriage of S. aureus just prior to cardiac surgery 2. To evaluate the interest of mupirocin dosing in the nasal swab as an indicator of observance with mupirocin decolonization. 3. Evaluate the value of measuring the mupirocin metabolite (monic acid) in the urine 4. If decolonization fails, determine by molecular typing (AP-PCR and / or spa typing) whether it is a relapse (same strain) or a recurrence by a different strain. 5. In case of similarity of strains, determine the incidence of resistance acquisition in S. aureus strains (mupirocin and chlorhexidine). 6. Determine the prevalence of nasal carriage of S. aureus 3 months after cardiac surgery;Primary end point(s): Analysis of failures of decolonization of patients carrying S. aureus in their nose;Timepoint(s) of evaluation of this end point: before surgery	—

Measure

Time frame

Main Objective: To identify the main risk factors for failure of pre-operative decolonization of S. aureus by antimicrobials in patients undergoing scheduled cardiac surgery.;Secondary Objective: 1. Determine the prevalence of nasal carriage of S. aureus just prior to cardiac surgery 2. To evaluate the interest of mupirocin dosing in the nasal swab as an indicator of observance with mupirocin decolonization. 3. Evaluate the value of measuring the mupirocin metabolite (monic acid) in the urine 4. If decolonization fails, determine by molecular typing (AP-PCR and / or spa typing) whether it is a relapse (same strain) or a recurrence by a different strain. 5. In case of similarity of strains, determine the incidence of resistance acquisition in S. aureus strains (mupirocin and chlorhexidine). 6. Determine the prevalence of nasal carriage of S. aureus 3 months after cardiac surgery;Primary end point(s): Analysis of failures of decolonization of patients carrying S. aureus in their nose;Timepoint(s) of evaluation of this end point: before surgery

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Secondary

Measure	Time frame
Secondary end point(s): 1. Number of patients detected positive in culture for S. aureus just prior to cardiac surgery compared to the total number of patients included. 2. Correlation between nasal dosing of mupirocin (calculated in mg / L of nasal secretion) and observance. 3. Correlation between urinary metabolite dosage of mupirocin (calculated in mg / L of urine) associated with the nasal dosage of mupirocin and decolonization efficiency (failure or not). 4. In case of failure of decolonization, study of the similarity of strains isolated in the same patient before-after decolonization to differentiate recurrences of recurrence. 5. In case of strains similarity, proportion of S. aureus strains resistant to mupirocin or chlorhexidine to evaluate failures related to antimicrobial selection pressure. 6. Number of patients detected positive in culture for S. aureus 3 months after cardiac surgery compared to the total number of patients included.;Timepoint(s) of evaluation of this end point: before surgery	—

Measure

Time frame

Secondary end point(s): 1. Number of patients detected positive in culture for S. aureus just prior to cardiac surgery compared to the total number of patients included. 2. Correlation between nasal dosing of mupirocin (calculated in mg / L of nasal secretion) and observance. 3. Correlation between urinary metabolite dosage of mupirocin (calculated in mg / L of urine) associated with the nasal dosage of mupirocin and decolonization efficiency (failure or not). 4. In case of failure of decolonization, study of the similarity of strains isolated in the same patient before-after decolonization to differentiate recurrences of recurrence. 5. In case of strains similarity, proportion of S. aureus strains resistant to mupirocin or chlorhexidine to evaluate failures related to antimicrobial selection pressure. 6. Number of patients detected positive in culture for S. aureus 3 months after cardiac surgery compared to the total number of patients included.;Timepoint(s) of evaluation of this end point: before surgery

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Countries

France

Contacts

Public ContactProject manager

CHU de Saint Etienne

marie.peuriere@chu-st-etienne.fr0477829272+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026