Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making

NCT03220386 | Unknown

• 1 other identifier: EA1/055/17
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study EPICS-6 consists of three study phases. Emergency Department patients are screened for nasal and pharyngeal colonisation with Methicillin sensitive and Methicillin resistant Staphylococcus aureus (MSSA/MRSA) using a point-of-care (POC)-PCR-testing method (cobas®LIAT®-System, Roche Molecular Systems Inc.) The first aim of this study is to describe the prevalence of MSSA/MRSA-colonisation in a routine cohort of Emergency Department patients. The second aim is to determine the impact of POC-guided decolonisation as compared to conventional laboratory testing on in-hospital infection rates with MSSA/MRSA in a pre-post-comparison study.

Conditions

Staphylococcus Aureus

Keywords

staphylococcus aureus; nosocomial infection; decolonization; emergency department

Outcome Measures

Primary Outcomes (2)

• MSSA/MRSA prevalence in a general ED-population

  number of patients with a positive POC-test result for nasal/oral MSSA/MRSA

  on admission to the ED

• MSSA/MRSA in-hospital infection rates

  number of in-hospital MSSA/MRSA infections in patients with known nasal/oral colonization with MSSA/MRSA. This outcome measure will be assessed for the time period between admission and discharge from hospital for up to 90 days after study inclusion. It will be assessed by routine MSSA/MRSA in-hospital testing and the respective test results will be retrieved from the hospital Information system.

  at discharge from hospital for up to 90 days after admission

Study Arms (1)

Emergency Department patients

OTHER

All patients will be tested for nasal MSSA/MRSA-colonization. Patients tested positive for nasal MSSA/MRSA-colonization receive a decolonization treatment. This treatment includes octinidin nasal treatment and skin washings.

Other: Decolonization by nasal Octinidin treatment and skin washings

Interventions

Decolonization by nasal Octinidin treatment and skin washings OTHER

Patients receive nasal Octinidin treatment and skin washings for five consecutive days

Emergency Department patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Emergency Department (ED) visit in one of the participating EDs

You may not qualify if:

• none

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin - Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections; Cross Infection; Emergencies

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Martin Möckel, PhD, MD

CONTACT

+49 30 450 553 472; martin.moeckel@charite.de

Anna Slagman, VMD, MSc

CONTACT

+49 30 450 665 659; anna.slagman@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Model Details: Patients screened positive for nasal MSSA or MRSA colonization during their treatment in the emergency department receive a standardized decolonization Treatment (Octinidin nasal ointment and skin washing)

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: July 18, 2017
• Study Start: May 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)