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Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community

This study is not yet open for participant recruitment.
Verified October 2008 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00765778
First received: October 2, 2008
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  Purpose

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.

Condition
Bacterial Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community:the Role of Family Members and Caregivers in Dissemination of MDR in Rehabilitation Centers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765778

Contacts
Contact: yaffa lerman, MD 97252-4266910 yaffale@tasmc.health.gov.il

Locations
Israel
Tasmc Not yet recruiting
Tel-aviv, Israel
Contact: Yaffa lerman, MD     97252-4266910     yaffale@tasmc.health.gov.il    
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Yehuda carmeli, MD TASMC
  More Information

Publications:

Responsible Party: yehuda carmeli, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00765778     History of Changes
Other Study ID Numbers: TASMC-08-YC-249-CTIL
Study First Received: October 2, 2008
Last Updated: October 15, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
resistant bacteria rehabilitation centers

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013