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Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community

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ClinicalTrials.gov Identifier: NCT00765778
Recruitment Status : Unknown
Verified October 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 3, 2008
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date October 2, 2008
First Posted Date October 3, 2008
Last Update Posted Date October 16, 2008
Study Start Date October 2008
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community
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
Brief Summary

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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Bacterial Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Gottesman T, Agmon O, Shwartz O, Dan M. Household transmission of carbapenemase-producing Klebsiella pneumoniae. Emerg Infect Dis. 2008 May;14(5):859-60. doi: 10.3201/eid1405.071340.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 2, 2008)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2014
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00765778
Other Study ID Numbers TASMC-08-YC-249-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party yehuda carmeli, Tel-Aviv Sourasky Medical Center
Study Sponsor Tel-Aviv Sourasky Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Yehuda carmeli, MD TASMC
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date October 2008