Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers

Study Overview
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Brief Summary
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S. aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal sample the determination of carriage status (persistent, intermittent or non-carriers) among patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus infections however, multiples schedules of decolonization have been proposed to all S. aureus carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We showed that only 50% of HD centers in France propose screening and decolonization of S. aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted decolonization of S. aureus persistent carriers using mupirocin nasal ointment and chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients compared to the absence of decolonization using a randomized open study methodology.

Detailed Description
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Hemodialysis patients will be randomized in 2 arms: one arm where persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers in this arm will be done every 3 months and a new decolonization will be proposed to patients found (again) persistent carriers. Determination of carriage status will be done using one nasal swab by following the algorithm previously described. Bacterial load will be determined by a quantitative S. aureus PCR (Polymerase Chain Reaction) : persistent carriers are the patient with a bacterial load > 103 CFU/mL (Colony Forming Unit) . The other arm is HD patients in which decolonization is not performed including impersistent carriers. All infections that occurred in enrolled patients will be counted in both groups

Official Title
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Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers on the Occurrence of S. Aureus Infections in Hemodialysis Patients

Conditions
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Hemodialysis Patients

Intervention / Treatment
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* Drug: Decolonization
* Other: No decolonization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age ≥ 18 years-old) Patient under chronic hemodialysis Patent that accepted to participate in the study with a written consent form signed Exclusion Criteria: Patients under peritoneal dialysis Patients with an active infection at the time of inclusion Patients previously treated by mupirocin and chlorhexidine for decolonization purpose Patients that received antimicrobials active on S. aureus during the month before the inclusion Patients with allergy to mupirocin or chlorhexidine Patients treated by hemodialysis transiently (non-terminal kidney failure) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decolonization<br>persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. | Drug: Decolonization<br>* Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers will be done every 3 months<br>|
| Placebo Comparator: No decolonization<br>HD patients in which decolonization is not performed including impersistent carriers. | Other: No decolonization<br>* Screening of persistent carriers in this arm will be done every 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S. aureus infection | Number of S. Aureus define by Centers for Disease Control | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endogenous S. aureus infections | same strain of carriage and infection | 12 months | 
| Bacteremias S. aureus | Impact of Bacteremias S. aureus | 12 months | 
| strain of S. aureus | Percentage of resistants strains of S. aureus at mupirocin and chlorhexidine | 12 months | 
| persistents carriers of S. aureus | Percentage of persistents carriers of S. aureus | Months : 3, 6, 9, 12 | 
| intermittents carriers of S. aureus | Percentage of intermittents carriers of S. aureus | Months : 3, 6, 9, 12 | 
| non-carriers carriers of S. aureus | Percentage of non-carriers carriers of S. aureus | Months : 3, 6, 9, 12 | 
| other bacterial infections | Impact of other bacterial infections without S. aureus | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, S. Aureus, Decolonization, Persistent carriage