Clinical trial NCT00765778: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Infection
Keywords: resistant bacteria rehabilitation centers
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-10-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-aviv
country: Israel
facility: Tasmc
Study officials:
affiliation: TASMC
name: Yehuda carmeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.