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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00765778
Other study ID # TASMC-08-YC-249-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 2, 2008
Last updated October 15, 2008
Start date October 2008
Est. completion date January 2014

Study information

Verified date October 2008
Source Tel-Aviv Sourasky Medical Center
Contact yaffa lerman, MD
Phone 97252-4266910
Email yaffale@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date January 2014
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Tasmc Tel-aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one year No
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