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

NCT ID: NCT02945722

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2024-10-26

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

Conditions

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Hemodialysis Patients

Keywords

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Hemodialysis S. Aureus Decolonization Persistent carriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Decolonization

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.

Group Type ACTIVE_COMPARATOR

Decolonization

Intervention Type DRUG

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

No decolonization

HD patients in which decolonization is not performed including impersistent carriers.

Group Type PLACEBO_COMPARATOR

No decolonization

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

No decolonization

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Botelho-Nevers, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CH d'Annecy-Genevois

Annecy, , France

Site Status

CH Emile Roux

Le Puy-en-Velay, , France

Site Status

Aural

Lyon, , France

Site Status

CH St-Joseph St-Luc

Lyon, , France

Site Status

AIDER Santé

Montpellier, , France

Site Status

ARTIC42

Saint-Etienne, , France

Site Status

Chu Saint-Etienne

Saint-Etienne, , France

Site Status

NephroCare

Sainte-Foy-lès-Lyon, , France

Site Status

CH Yssingeaux - Hôpital Local

Yssingeaux, , France

Site Status

Countries

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France

Other Identifiers

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2016-004381-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1608170

Identifier Type: -

Identifier Source: org_study_id