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

Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers on the Occurrence of S. Aureus Infections in Hemodialysis Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Drug: Decolonization; Other: No decolonization

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elisabeth Botelho-Nevers, MD PhD; Phone Number: +33 (0)477829234; Email: elisabeth.botelho-nevers@chu-st-etienne.fr
• Study Contact Backup: Name: Arnauld GARCIN, CRA; Phone Number: +33 (0)477120286; Email: arnauld.garcin@chu-st-etienne.fr

Study Locations

• France
  • Annecy, France
    • Recruiting
    • CH d'Annecy-Genevois
    • Principal Investigator: Benoît FRANKO, MD
    • Sub-Investigator: Déborah CHAINTREUIL, MD
  • Annonay, France
    • Not yet recruiting
    • Ch Annonay
    • Principal Investigator: Carole DEPRELE, MD
  • Cannes, France
    • Not yet recruiting
    • Ch Cannes
    • Principal Investigator: Manuela DODOI, MD
  • La Tronche, France
    • Not yet recruiting
    • AGDUC
    • Principal Investigator: Nadège MINGAT, MD
  • Le Puy-en-Velay, France
    • Recruiting
    • Ch Emile Roux
    • Principal Investigator: Marc BOUILLER, MD
    • Sub-Investigator: Viorica BARBU, MD
  • Lyon, France
    • Not yet recruiting
    • CHU LYON
    • Principal Investigator: Laurent JUILLARD, MD
  • Lyon, France
    • Terminated
    • Aural
  • Lyon, France
    • Recruiting
    • CH St-Joseph St-Luc
    • Principal Investigator: Cécile CHAUVET, MD
    • Sub-Investigator: Amélie Belloi, MD
  • Montpellier, France
    • Recruiting
    • AIDER Santé
    • Principal Investigator: Nathalie RAYNAL, MD
    • Sub-Investigator: Cécile GUIRAUD, MD
    • Sub-Investigator: Cédric FORMET, MD
    • Sub-Investigator: Melody CUNY-MERLE, MD
  • Roanne, France
    • Not yet recruiting
    • CH Roanne
    • Principal Investigator: Emerson N'SEMBANI, MD
  • Saint Etienne, France
    • Recruiting
    • ARTIC42
    • Principal Investigator: Aida AFIANI, MD
    • Sub-Investigator: Linda AZZOUZ, MD
    • Sub-Investigator: Aline CHABROUX-SEFFERT, MD
    • Sub-Investigator: Jean-Christophe SZELAG, MD
    • Sub-Investigator: Abdelaziz ZIANE, MD
    • Sub-Investigator: Perrine JULLIEN, MD
  • Saint-etienne, France
    • Recruiting
    • CHU Saint-etienne
    • Principal Investigator: Elisabeth BOTHELO-NEVERS, MD PhD
    • Sub-Investigator: Amandine GAGNEUX-BRUNON, MD
    • Sub-Investigator: Fréderic LUCHT, MD PhD
    • Sub-Investigator: Philippe BERTHELOT, MD PhD
    • Sub-Investigator: Florence GRATTARD, MD
    • Sub-Investigator: Anne CARRICAJO, MD
    • Sub-Investigator: Christophe MARIAT, MD PhD
    • Sub-Investigator: Hesham MOHEY, MD
    • Sub-Investigator: Mariana DINIC, MD
    • Sub-Investigator: Vincent BISACCIA, MD PhD
    • Sub-Investigator: Eric ALAMARTINE, MD PhD
    • Sub-Investigator: Damien THIBAUDIN, MD
    • Sub-Investigator: Paul VERHOEVEN, MD
  • Sainte-foy-les-Lyon, France
    • Recruiting
    • NephroCare
    • Principal Investigator: Manolie MEHDI, MD
    • Sub-Investigator: Christie LORRIAUX, MD
  • Valence, France
    • Not yet recruiting
    • Ch Valence
    • Sub-Investigator: Sabine MENDES, MD
    • Sub-Investigator: Jacques SARTRE, MD
  • Vienne, France
    • Not yet recruiting
    • CH de Vienne - Hôpital Lucien Hussel
    • Principal Investigator: Patrick HALLONET, MD
    • Sub-Investigator: Léopold ADELAIDE, MD
    • Sub-Investigator: Marie BONJEAN, MD
    • Sub-Investigator: Anissa BOUAZIZ, MD
  • Villefranche-sur-Saône, France
    • Recruiting
    • Villefranche sur Saône: ATIRRA et Hôpital Nord Ouest
    • Principal Investigator: Jacques HANNOUN, MD
    • Sub-Investigator: Cécile TEUMA, MD
    • Sub-Investigator: Gary DAVID, MD
    • Sub-Investigator: Romain BRICCA, MD
  • Yssingeaux, France
    • Recruiting
    • CH Yssingeaux - Hôpital Local
    • Principal Investigator: Marc BOUILLER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Placebo Comparator: No decolonization; HD patients in which decolonization is not performed including impersistent carriers.	Other: No decolonization; Screening of persistent carriers in this arm will be done every 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S. aureus infection	Number of S. Aureus define by Centers for Disease Control	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endogenous S. aureus infections	same strain of carriage and infection	12 months
Bacteremias S. aureus	Impact of Bacteremias S. aureus	12 months
strain of S. aureus	Percentage of resistants strains of S. aureus at mupirocin and chlorhexidine	12 months
persistents carriers of S. aureus	Percentage of persistents carriers of S. aureus	Months : 3, 6, 9, 12
intermittents carriers of S. aureus	Percentage of intermittents carriers of S. aureus	Months : 3, 6, 9, 12
non-carriers carriers of S. aureus	Percentage of non-carriers carriers of S. aureus	Months : 3, 6, 9, 12
other bacterial infections	Impact of other bacterial infections without S. aureus	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Elisabeth Botelho-Nevers, MD PhD, CHU Saint-etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimated): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis; Decolonization; S. Aureus; Persistent carriage
• Other Study ID Numbers: 1608170; 2016-004381-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No