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

Hemodialysis Patients Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945722
• Other study ID #: 1608170
• Secondary ID: 2016-004381-25
• Status: Recruiting
• Phase: Phase 4
• Start date: February 23, 2018
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Elisabeth Botelho-Nevers, MD PhD
• Phone: (0)477829234
• Email: elisabeth.botelho-nevers[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

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

Locations

Country	Name	City	State
France	CH d'Annecy-Genevois	Annecy
France	Ch Annonay	Annonay
France	Ch Cannes	Cannes
France	AGDUC	La Tronche
France	CH Emile Roux	Le Puy-en-Velay
France	Aural	Lyon
France	CH St-Joseph St-Luc	Lyon
France	CHU Lyon	Lyon
France	AIDER Santé	Montpellier
France	CH Roanne	Roanne
France	ARTIC42	Saint Etienne
France	Chu Saint-Etienne	Saint-etienne
France	NephroCare	Sainte-foy-les-Lyon
France	CH Valence	Valence
France	CH de Vienne - Hôpital Lucien Hussel	Vienne
France	Villefranche sur Saône: ATIRRA et Hôpital Nord Ouest	Villefranche-sur-Saône
France	CH Yssingeaux - Hôpital Local	Yssingeaux

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S. aureus infection	Number of S. Aureus define by Centers for Disease Control	12 months
Secondary	endogenous S. aureus infections	same strain of carriage and infection	12 months
Secondary	Bacteremias S. aureus	Impact of Bacteremias S. aureus	12 months
Secondary	strain of S. aureus	Percentage of resistants strains of S. aureus at mupirocin and chlorhexidine	12 months
Secondary	persistents carriers of S. aureus	Percentage of persistents carriers of S. aureus	Months : 3, 6, 9, 12
Secondary	intermittents carriers of S. aureus	Percentage of intermittents carriers of S. aureus	Months : 3, 6, 9, 12
Secondary	non-carriers carriers of S. aureus	Percentage of non-carriers carriers of S. aureus	Months : 3, 6, 9, 12
Secondary	other bacterial infections	Impact of other bacterial infections without S. aureus	12 months