Evaluation of an Algorithm for Identifying Persistent Nasal Staphylococcus Aureus Carriage in a Cohort of Healthy Volunteers and Patients Regularly Monitored at the CHU of Saint-Etienne

NCT02557568 | Completed

• 1 other identifier: 1108059
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The nasal carriage of Staphylococcus aureus is a major risk factor of S. aureus infection, notably in hemodialysis patients (HPs). Decolonization strategies were shown able to reduce the rate of S. aureus infection in this category of patients although the risk of emergence of antimicrobial resistance persists. Approximately one quarter of the general population is colonized by S. aureus in the anterior part of the nostril (vestibulum nasi). Three main categories of nasal carriers have been historically identified: persistent carriers (20%, 12-30%\]), intermittent carriers (30%, \[16-70%\]) and non-carriers (50% \[16-69%\]). By contrast to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of S. aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery. Persistent carriers are characterized by a higher nasal bacterial load, a longer duration of carriage, a lower rate of exchange of S. aureus strains, and a particular affinity for the carried strain. However, there is no consensual definition of this persistent carriage state. In previous studies, 5 to 12 nasal sampling episodes were realized for a period ranging from 5 weeks to 8 years. The index of carriage, corresponding to the number of samples positive for S. aureus divided by the total number of samples, has been proposed to standardize the definition of the carriage state. According to standard tools, it is almost impossible to determine the nasal carriage state in routine practice. Recently, an algorithm based on one or two quantitative cultures from nasal samples taken within 2 days that was able to distinguish accurately persistent and non-persistent nasal carriers of S. aureus has been described; only one nasal sample was needed in more than 9 cases out of 10. The aim of the present study was to assess prospectively the reliability of this algorithm in clinical practice in a cohort of healthcare workers (HCWs) and HPs and to check its ability for identifying patients with the highest risk of S. aureus infection

Conditions

Staphylococcal Infections

Keywords

nasal carriage; Staphylococcus aureus; hemodialysis patients

Outcome Measures

Primary Outcomes (1)

• S. aureus nasal carriage state

  HPs and HCWs were sampled over a 10-week period using at least 7 and at most 12 sampling episodes. S. aureus persistent nasal carriers were defined by an index of carriage greater than or equal to 0.8 and S. aureus intermittent nasal carriers by a positive index of carriage lower than 0.8. An index of carriage is defined for each patients by the ratio : positive sample/total sample

  10-week period

Study Arms (2)

Hemodialysis patients (HPs)

EXPERIMENTAL

staphylococcus aureus carriage is measured in nose

Other: Staphylococcus aureus carriage

Healthcare Workers (HCWs)

EXPERIMENTAL

staphylococcus aureus carriage is measured in nose

Other: Staphylococcus aureus carriage

Interventions

Staphylococcus aureus carriage OTHER

Staphylococcus aureus carriage is measured in the nose. Nasal samples were taken by the nursing staff of the ward using nylon flocked swab. Prior taking the sample, swabs were wetted using an additional tube containing a sponge impregnated with normal saline solution.

Healthcare Workers (HCWs); Hemodialysis patients (HPs)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Volunteers or hemodialysis patients
• carrier state of S. aureus unknown
• written consent

You may not qualify if:

• chronic soft skin tissue infection due to S. aureus or eczema,
• ongoing or completed antibiotic treatment for less than 15 days,
• nasal decolonization by mupirocin or skin decolonization by antiseptic bath for at least 5 consecutive days in the previous year,
• pregnancy,
• HIV infection
• hemostasis disorder.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Florence Grattard

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

FR (1)