Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 83 of 640 for:    test AND point-of-care

Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making (EPICS-6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03220386
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Martin Moeckel, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Other: Decolonization by nasal Octinidin treatment and skin washings Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
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)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA

Arm Intervention/treatment
Emergency Department patients
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
Patients receive nasal Octinidin treatment and skin washings for five consecutive days




Primary Outcome Measures :
  1. MSSA/MRSA prevalence in a general ED-population [ Time Frame: on admission to the ED ]
    number of patients with a positive POC-test result for nasal/oral MSSA/MRSA

  2. MSSA/MRSA in-hospital infection rates [ Time Frame: at discharge from hospital for up to 90 days after admission ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

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): NCT03220386


Contacts
Layout table for location contacts
Contact: Martin Möckel, PhD, MD +49 30 450 553 472 martin.moeckel@charite.de
Contact: Anna Slagman, VMD, MSc +49 30 450 665 659 anna.slagman@charite.de

Locations
Layout table for location information
Germany
Charité Universitätsmedizin - Berlin Recruiting
Berlin, Germany, 13353
Contact: Martin Möckel, Prof. Dr.    0049 30 553472    martin.moeckel@charite.de   
Contact: Anna Slagman, Dr. MSc.    004930450553037    anna.slagman@charite.de   
Sub-Investigator: Dorothee Riedlinger, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany

Layout table for additonal information
Responsible Party: Martin Moeckel, Professor Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03220386     History of Changes
Other Study ID Numbers: EA1/055/17
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin Moeckel, Charite University, Berlin, Germany:
staphylococcus aureus
nosocomial infection
decolonization
emergency department

Additional relevant MeSH terms:
Layout table for MeSH terms
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents