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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03220386
Acronym
EPICS-6
Enrollment
1000
Registered
2017-07-18
Start date
2017-05-01
Completion date
2018-08-01
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus Aureus

Keywords

staphylococcus aureus, nosocomial infection, decolonization, emergency department

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.

Detailed description

The study EPICS-6 consists of three study phases. In phase one the novel POC-PCR-testing method for MSSA/MRSA-proof (cobas®LIAT®-System, Roche Molecular Systems Inc.) is technically established and integrated in Emergency Department procedures. After evaluation of processes and sample handling the second phase of this study assesses the prevalence of positive MSSA/MRSA-POC-testing in the general ED-population and in different risk groups. Based on the results of the previous study phases, the final phase comprises an interventional pre-post-comparison study. The interventional study assesses the impact of POC-result guided early decolonisation of MSSA/MRSA-colonized patients on in-hospital infection rates with MSSA/MRSA.

Interventions

OTHERDecolonization by nasal Octinidin treatment and skin washings

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

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
MSSA/MRSA prevalence in a general ED-populationon admission to the EDnumber of patients with a positive POC-test result for nasal/oral MSSA/MRSA
MSSA/MRSA in-hospital infection ratesat discharge from hospital for up to 90 days after admissionnumber 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.

Countries

Germany

Contacts

Primary ContactMartin Möckel, PhD, MD
martin.moeckel@charite.de+49 30 450 553 472
Backup ContactAnna Slagman, VMD, MSc
anna.slagman@charite.de+49 30 450 665 659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026