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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)

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ClinicalTrials.gov Identifier: NCT02557568
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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


Condition or disease Intervention/treatment Phase
Staphylococcal Infections Other: Staphylococcus aureus carriage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : October 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hemodialysis patients (HPs)
staphylococcus aureus carriage is measured in nose
Other: Staphylococcus aureus carriage
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.

Experimental: Healthcare Workers (HCWs)
staphylococcus aureus carriage is measured in nose
Other: Staphylococcus aureus carriage
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 Measures :
  1. S. aureus nasal carriage state [ Time Frame: 10-week period ]
    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



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557568


Locations
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France
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Florence Grattard CHU Saint-Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02557568    
Other Study ID Numbers: 1108059
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
nasal carriage
Staphylococcus aureus
hemodialysis patients
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections