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

NCT02945722 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2024-12-18

No results posted yet for this 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.

Conditions

  • Hemodialysis Patients

Interventions

DRUG

Decolonization

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

OTHER

No decolonization

Screening of persistent carriers in this arm will be done every 3 months

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Elisabeth Botelho-Nevers, MD PhD · CHU SAINT-ETIENNE

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2024-10-26
Completion
2024-10-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02945722 on ClinicalTrials.gov