Clinical trial NCT02945722: Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemodialysis Patients
Keywords: Hemodialysis
S. Aureus
Decolonization
Persistent carriage
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-10-26
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: S. aureus infection
timeFrame: 12 months
Secondary outcomes:
measure: endogenous S. aureus infections
timeFrame: 12 months
measure: Bacteremias S. aureus
timeFrame: 12 months
measure: strain of S. aureus
timeFrame: 12 months
measure: persistents carriers of S. aureus
timeFrame: Months : 3, 6, 9, 12
measure: intermittents carriers of S. aureus
timeFrame: Months : 3, 6, 9, 12
measure: non-carriers carriers of S. aureus
timeFrame: Months : 3, 6, 9, 12
measure: other bacterial infections
timeFrame: 12 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH d'Annecy-Genevois
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Lyon
country: France
facility: Aural
city: Lyon
country: France
facility: CH St-Joseph St-Luc
city: Montpellier
country: France
facility: AIDER Santé
city: Saint Etienne
country: France
facility: ARTIC42
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
city: Sainte-foy-les-Lyon
country: France
facility: NephroCare
city: Yssingeaux
country: France
facility: CH Yssingeaux - Hôpital Local
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Elisabeth Botelho-Nevers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: