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Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure (STAdécol)

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ClinicalTrials.gov Identifier: NCT03685487
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
Staphylococcus aureus nasal carriage is a well-known risk factor for S. aureus surgical site infections (SSI). According to a recent study demonstrating 60% reduction risk of SSI due this bacterium after patients' screening and decolonization, recent French and WHO guidelines recommend in cardiac surgery the decolonization of nasal S. aureus carriers before surgery. In practice the decolonization procedures are not well-defined according notably to the duration and time of delivery before surgery and doses of topical antimicrobial drugs. The aim of the proposed study is to investigate the factors associated with failures of S. aureus decolonization: carriage state, compliance with treatment, S. aureus capacity of internalization in nasal epithelial cells, resistance to antimicrobial drugs used. This study will allow (i) to measure the frequency of patients with residual S. aureus carriage just before surgery, whatever they have been decolonized or not, (ii) to characterize the S. aureus nasal carriage state of patients before surgery, and (iii) to investigate the adding value of mupirocin dosage in the nose and urines of decolonized patients as a marker of compliance and efficacy of the decolonization process.

Condition or disease Intervention/treatment
Staphylococcus Aureus Procedure: decolonization Other: compliance questionnaire

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
patients with failures of decolonization S. aureus
patients with failures of decolonization S. aureus in their nose
Procedure: decolonization
current practice : V1 : consultation to the service : nasal sample for all 5 days before surgery : order sent with decolonization procedure : nasal mupirocin, shower and mouthwash V2 : admission to the service : nasal sample for all and urine sample for decolonized patients V3 : nasal sample for all

Other: compliance questionnaire
We asked if the patient has done the whole decolonization procedure




Primary Outcome Measures :
  1. number of participants with failure of decolonization of nasal carriers of S. aureus [ Time Frame: just before surgery ]
    These patients were screened positive for S. aureus in nasal swab culture collected during the preoperative consultation of cardiac surgery, who received a decolonization prescription and who are again detected positive in culture for S. aureus on the nasal collection performed on admission to the surgery department (just before surgery).


Secondary Outcome Measures :
  1. Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patients [ Time Frame: before surgery ]
  2. Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients [ Time Frame: 3 months ]
  3. Correlation between nasal dosing of mupirocin and compliance [ Time Frame: 3 months ]
  4. Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not). [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be offered to all major patient who needs cardiac surgery
Criteria

Inclusion Criteria:

  • Patient to benefit from cardiac surgery scheduled at Saint-Etienne University Hospital
  • Surgery of first intention (no resumption)
  • Patient affiliated or entitled to a social security scheme
  • Patient agreeing to participate in the study and having signed the informed consent

Exclusion Criteria:

  • Surgery in a context of infection
  • Surgery in an emergency and semi-emergency context
  • Protected major patient
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685487


Contacts
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Contact: Florence GRATTARD, MD 0477828105 ext +33 florence.grattard@chu-st-etienne.fr
Contact: Marie PEURIERE 0477829272 ext +33 marie.peuriere@chu-st-etienne.fr

Locations
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France
Chu Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Florence GRATTARD, MD       florence.grattard@chu-st-etienne.fr   
Principal Investigator: Florence GRATTARD, MD         
Sub-Investigator: Philippe BERTHELOT, MD         
Sub-Investigator: Elisabeth BOTELHO NEVERS, MD         
Sub-Investigator: Jean Pierre FAVRE, MD         
Sub-Investigator: Paul VERHOEVEN, MD         
Sub-Investigator: Julie GAGNAIRE, MD         
Sub-Investigator: Salvatore CAMPISI, MD         
Sub-Investigator: Jonathan BENTZ, MD         
Sub-Investigator: Anne CARRICAJO, MD         
Sub-Investigator: Frédéric LUCHT, MD         
Sub-Investigator: Bruno POZZETTO, MD         
Sub-Investigator: Jean Nöel ALBERTINI, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Florence GRATTARD, MD CHU de Saint Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03685487    
Other Study ID Numbers: 18CH049
2018-001505-90 ( Other Identifier: ANSM )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
decolonization
mupirocin
cardiac surgery