Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT02794831 - Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
Active, not recruiting NCT02533609 - Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
Completed NCT01892358 - Preventing Bacterial and Viral Infections Among Injection Drug Users N/A
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT01446289 - Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings Phase 2
Completed NCT01059890 - Cerebral Antibiotics Distribution After Acute Brain Injury Phase 1
Completed NCT00389558 - Antiseptic Use and Dressing Application Phase 4
Completed NCT00760279 - An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates Phase 1
Completed NCT02311816 - Increase in Procalcitonin Kinetics May be a Good Indicator of Starting Empirical Antibiotic Treatment in Critically Ill Patients N/A
Completed NCT01225042 - The Effect of Probiotics on E. Coli Gastroenteritis N/A
Completed NCT00800488 - Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months N/A
Completed NCT00915213 - Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy N/A
Terminated NCT00307099 - Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU Phase 3
Recruiting NCT04479657 - Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection Early Phase 1
Completed NCT03299894 - Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department N/A
Completed NCT01817075 - Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant Phase 3
Completed NCT01244698 - Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction Phase 4
Completed NCT01250574 - Neutrophil CD64 and Procalcitonin as Novel Biomarkers for Postoperative Infections
Completed NCT01012089 - Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease N/A
Completed NCT00939562 - Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate Phase 4