- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00765778
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community
October 15, 2008 updated by: Tel-Aviv Sourasky Medical Center
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community:the Role of Family Members and Caregivers in Dissemination of MDR in Rehabilitation Centers
Detailed activity:
- Family members and caregivers of carrier residents will be screened for ESBL and MRSA. Screening will be performed by obtaining nares and perirectal cultures. Nares cultures will be obtained by ward staff or research personnel who are experienced in performing this activity: a moisture swab will be applied gently to the distal part of both nares. Perirectal cultures, will be taken by swab, who will be applied to the perirectal area, either by staff as mentioned above, or will be given to the participants to perform by himself (with explanation on how to perform it).
- The Family and Caregiver Screening Form will be filled out; results of screening will be added to the forms. This data will be stored after removal of all Family members' identifiers for further analysis.
- In order to allow follow up, a list linking between the Family members' study number and his identifying details will be kept separately in the rehabilitation center. This list will not be transferred elsewhere.
Study Overview
Status
Unknown
Conditions
Detailed Description
Detailed activity:
- Family members and caregivers of carrier residents will be screened for ESBL and MRSA. Screening will be performed by obtaining nares and perirectal cultures. Nares cultures will be obtained by ward staff or research personnel who are experienced in performing this activity: a moisture swab will be applied gently to the distal part of both nares. Perirectal cultures, will be taken by swab, who will be applied to the perirectal area, either by staff as mentioned above, or will be given to the participants to perform by himself (with explanation on how to perform it).
- The Family and Caregiver Screening Form will be filled out; results of screening will be added to the forms. This data will be stored after removal of all Family members' identifiers for further analysis.
- In order to allow follow up, a list linking between the Family members' study number and his identifying details will be kept separately in the rehabilitation center. This list will not be transferred elsewhere.
- Providing results to family members: results of screening will be / will not be reported to the participant (family member) based on local decision in each center.
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel-aviv, Israel
- TASMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Family members or caregivers of patient hospitalized in rehabilitation centers and who is known carrier of the target resistant population.
Description
Inclusion Criteria:
- Family members or caregivers of patient hospitalized in rehabilitation center and who is known carrier of the target resistant population.
- Participating member older than 18 years, who attend the patient at least once a week, will be eligible for inclusion.
Exclusion Criteria:
- Age 18 years or less, attending the patient less than once a week.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Family members and caregivers carriers of patients who are carriers of resistant bacteria /Family members and caregivers of patients who are carriers of resistant bacteria
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yehuda carmeli, MD, TASMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
October 1, 2009
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
October 2, 2008
First Submitted That Met QC Criteria
October 2, 2008
First Posted (Estimate)
October 3, 2008
Study Record Updates
Last Update Posted (Estimate)
October 16, 2008
Last Update Submitted That Met QC Criteria
October 15, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-08-YC-249-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.