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

Last updated: December 16, 2024
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Terminated

Phase

4

Condition

N/A

Treatment

No decolonization

Decolonization

Clinical Study ID

NCT02945722
1608170
2016-004381-25
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients under peritoneal dialysis

  • Patients with an active infection at the time of inclusion

  • Patients previously treated by mupirocin and chlorhexidine for decolonizationpurpose

  • Patients that received antimicrobials active on S. aureus during the month beforethe inclusion

  • Patients with allergy to mupirocin or chlorhexidine

  • Patients treated by hemodialysis transiently (non-terminal kidney failure)

  • Pregnancy

Study Design

Total Participants: 434
Treatment Group(s): 2
Primary Treatment: No decolonization
Phase: 4
Study Start date:
February 23, 2018
Estimated Completion Date:
October 26, 2024

Study 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

Connect with a study center

  • CH d'Annecy-Genevois

    Annecy,
    France

    Site Not Available

  • Ch Annonay

    Annonay,
    France

    Site Not Available

  • Ch Cannes

    Cannes,
    France

    Site Not Available

  • AuraSanté

    Cebazat,
    France

    Site Not Available

  • Chu Clermont-Ferrand

    Clermont-ferrand,
    France

    Site Not Available

  • CHU Grenoble

    Grenoble,
    France

    Site Not Available

  • AGDUC

    La Tronche,
    France

    Site Not Available

  • CH Emile Roux

    Le Puy-en-Velay,
    France

    Site Not Available

  • Aural

    Lyon,
    France

    Site Not Available

  • CH St-Joseph St-Luc

    Lyon,
    France

    Site Not Available

  • CHU Lyon

    Lyon,
    France

    Site Not Available

  • AIDER Santé

    Montpellier,
    France

    Site Not Available

  • CH Roanne

    Roanne,
    France

    Site Not Available

  • ARTIC42

    Saint Etienne,
    France

    Site Not Available

  • Chu Saint-Etienne

    Saint-etienne,
    France

    Site Not Available

  • NephroCare

    Sainte-foy-les-Lyon,
    France

    Site Not Available

  • CH Valence

    Valence,
    France

    Site Not Available

  • CH de Vienne - Hôpital Lucien Hussel

    Vienne,
    France

    Site Not Available

  • Villefranche sur Saône: ATIRRA et Hôpital Nord Ouest

    Villefranche-sur-Saône,
    France

    Site Not Available

  • CH Yssingeaux - Hôpital Local

    Yssingeaux,
    France

    Site Not Available

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