NCT02945722

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
434

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_4

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

6.7 years

First QC Date

October 25, 2016

Last Update Submit

December 16, 2024

Conditions

Hemodialysis Patients

Keywords

HemodialysisS. AureusDecolonizationPersistent carriage

Outcome Measures

Primary Outcomes (1)

  • S. aureus infection

    Number of S. Aureus define by Centers for Disease Control

    12 months

Secondary Outcomes (7)

  • endogenous S. aureus infections

    12 months

  • Bacteremias S. aureus

    12 months

  • strain of S. aureus

    12 months

  • persistents carriers of S. aureus

    Months : 3, 6, 9, 12

  • intermittents carriers of S. aureus

    Months : 3, 6, 9, 12

  • +2 more secondary outcomes

Study Arms (2)

Decolonization

ACTIVE COMPARATOR

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

No decolonization

PLACEBO COMPARATOR

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

Other: No decolonization

Interventions

DecolonizationDRUG

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

Decolonization
No decolonizationOTHER

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

No decolonization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (age ≥ 18 years-old)
  • Patient under chronic hemodialysis
  • Patent that accepted to participate in the study with a written consent form signed

You may not qualify if:

  • Patients under peritoneal dialysis
  • Patients previously treated by mupirocin and chlorhexidine for decolonization purpose
  • Patients with allergy to mupirocin or chlorhexidine
  • Patients treated by hemodialysis transiently (non-terminal kidney failure)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CH d'Annecy-Genevois

Annecy, France

Location

CH Emile Roux

Le Puy-en-Velay, France

Location

Aural

Lyon, France

Location

CH St-Joseph St-Luc

Lyon, France

Location

AIDER Santé

Montpellier, France

Location

ARTIC42

Saint-Etienne, France

Location

Chu Saint-Etienne

Saint-Etienne, France

Location

NephroCare

Sainte-Foy-lès-Lyon, France

Location

CH Yssingeaux - Hôpital Local

Yssingeaux, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Elisabeth Botelho-Nevers, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 26, 2016

Study Start

February 23, 2018

Primary Completion

October 26, 2024

Study Completion

October 26, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)