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 (ScreenStaph)
Primary Purpose
Staphylococcal Infections
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Staphylococcus aureus carriage
Sponsored by
About this trial
This is an interventional diagnostic trial for Staphylococcal Infections focused on measuring nasal carriage, Staphylococcus aureus, hemodialysis patients
Eligibility Criteria
Inclusion Criteria:
- Healthy Volunteers or hemodialysis patients
- carrier state of S. aureus unknown
- written consent
Exclusion Criteria:
- 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.
Sites / Locations
- CHU Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hemodialysis patients (HPs)
Healthcare Workers (HCWs)
Arm Description
staphylococcus aureus carriage is measured in nose
staphylococcus aureus carriage is measured in nose
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02557568
First Posted
September 22, 2015
Last Updated
September 23, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02557568
Brief Title
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
Acronym
ScreenStaph
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
Keywords
nasal carriage, Staphylococcus aureus, hemodialysis patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemodialysis patients (HPs)
Arm Type
Experimental
Arm Description
staphylococcus aureus carriage is measured in nose
Arm Title
Healthcare Workers (HCWs)
Arm Type
Experimental
Arm Description
staphylococcus aureus carriage is measured in nose
Intervention Type
Other
Intervention Name(s)
Staphylococcus aureus carriage
Intervention Description
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.
Primary Outcome Measure Information:
Title
S. aureus nasal carriage state
Description
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
Time Frame
10-week period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers or hemodialysis patients
carrier state of S. aureus unknown
written consent
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Grattard
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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