Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01187758
Other study ID # SHEBA-01-2357-GRY-CTIL
Secondary ID
Status Completed
Phase N/A
First received August 23, 2010
Last updated August 23, 2010
Start date February 2002
Est. completion date December 2007

Study information

Verified date August 2010
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

This study aims to implement judicious antibiotic prescription habits to primary care pediatricians using a multifacet educational intervention and assess two main outcomes: 1) Direct outcome - prescription rates of the physicians. 2)Indirect outcome - carriage of antibiotic resistant bacteria by the treated population, specifically nasopharyngeal S. pneumoniae, nasal S. aureus and rectal E.coli.


Description:

Background: Bacterial antibiotic resistance is an increasing problem.

Aims: This study aims to implement judicious antibiotic prescription habits among 30 physicians and their treated population as compared to a control group of 30 physicians and their treated population. The outcomes to be measured are:

1. Change in antibiotic prescriptions to the treated patients of the intervention vs. control physicians during the study period (4years).

2. Change in carriage of antibiotic resistant pathogens, specifically nasopharyngeal penicillin resistant S. pneumoniae,nasal MRSA, and rectal quinolone resistant E. coli.

Study design: All primary care pediatricians of Hashfela district of Macabbi Healthcare services who will agree to participate will be randomly assigned to an intervention or control group. The intervention group will be led by local leaders (primary care physicians from that district) and will take part in educational activities involving annual workshops and quarterly focus group meetings. The intervention is a multifacet intervention that will include guideline preparation, knowledge building, dealing with uncertainties, etc.

The patients of both intervention and control physicians will be screened twice a year for carriage of the bacteria mentioned above. Cross-sectional screening of the treated population will be carried in Summer and winter for 5 consecutive years. Screening will include signing an informed consent, filling a questionnaire and screening with nasal, nasopharyngeal and rectal swabs.


Recruitment information / eligibility

Status Completed
Enrollment 5700
Est. completion date December 2007
Est. primary completion date October 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 5 Years
Eligibility Inclusion Criteria:

- All treated patients of the participating physicians under the age of 5y, who came for any reason for a visit during the study period, who's parents agreed to participate.

Exclusion Criteria:

The only reason to exclude a child from being recruited was age>5y or refusal of the parent/child to participate.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Workshops and focus group meetings
Multifacet intervention that includes: Guideline preparation and implementation, preparing clinic campaign, improving knowledge about Ab resistance and diagnosis of respiratory infections

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Sheba Medical Center Maccabi Healthcare Services, Israel

Outcome

Type Measure Description Time frame Safety issue
Primary antibiotic prescription rate of physicians Antibiotic prescrption rate at baseline will be compared to changes following the intervention between the 2 groups (control and intervention). 5 years No
Secondary Carriage of antibiotic resistant bacteria by treated patients Every summer and winter a crosssectional survey of the treated patients of the control and intervention physicians will be carried out to determine the rate of carriage of penicillin-resistant S. pneumonaie, MRSA and Quinolone-resistant E.coli. 4 years No
See also
  Status Clinical Trial Phase
Recruiting NCT06002685 - Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention N/A
Completed NCT03388944 - PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis N/A
Completed NCT04963764 - Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia Early Phase 1
Completed NCT04631185 - Surgical Site Infection and Antibiotic Use Study N/A
Completed NCT05726253 - Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia Early Phase 1
Completed NCT03241316 - Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion
Recruiting NCT04358289 - Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam N/A
Not yet recruiting NCT06371560 - Antibiotics, Antibiotic Resistance, and Prescribing Practices Among Periodontists: Cross Sectional KAP Study
Completed NCT06317415 - Intervention on Non-prescription Antibiotic Use Among the Public N/A