Israeli Judicious Antibiotic Prescription Study

Antibiotic Use Clinical Trial

— IJAP  

Official title:

Can Change in Physicians' Prescribing Habits Decrease Carriage of Resistant Bacteria in the Community?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187758
• Other study ID #: SHEBA-01-2357-GRY-CTIL
• 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

• Antibiotic Use
• Carriage of Antibiotic Resistant Pathogens

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