Israeli Judicious Antibiotic Prescription Study (IJAP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Antibiotic Use Carriage of Antibiotic Resistant Pathogens |
Behavioral: Workshops and focus group meetings |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Can Change in Physicians' Prescribing Habits Decrease Carriage of Resistant Bacteria in the Community? |
- antibiotic prescription rate of physicians [ Time Frame: 5 years ] [ Designated as safety issue: No ]Antibiotic prescrption rate at baseline will be compared to changes following the intervention between the 2 groups (control and intervention).
- Carriage of antibiotic resistant bacteria by treated patients [ Time Frame: 4 years ] [ Designated as safety issue: No ]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.
| Enrollment: | 5700 |
| Study Start Date: | February 2002 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Educational intervention
Multifacet educational intervention that includes workshops, seminars and focus group meetings
|
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
|
|
No Intervention: Control - no intervention
This group did not have any intervention, but their population was screened for carriage of antibiotic resistant bacteria
|
Detailed 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:
- Change in antibiotic prescriptions to the treated patients of the intervention vs. control physicians during the study period (4years).
- 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.
Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided by Sheba Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gili Regev-Yochay, Sheba medical Center |
| ClinicalTrials.gov Identifier: | NCT01187758 History of Changes |
| Other Study ID Numbers: | SHEBA-01-2357-GRY-CTIL |
| Study First Received: | August 23, 2010 |
| Last Updated: | August 23, 2010 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
antibiotic use antibiotic prescription antibiotic resistant S. pneumoniae MRSA |
Additional relevant MeSH terms:
|
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013