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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    850
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 14 June 2022

Summary

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.

Description

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

Details
Condition Hemodialysis Patients
Treatment Decolonization, No decolonization
Clinical Study IdentifierNCT02945722
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

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
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