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Israeli Judicious Antibiotic Prescription Study (IJAP)

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ClinicalTrials.gov Identifier: NCT01187758
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : August 24, 2010
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by:
Sheba Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Antibiotic Use Carriage of Antibiotic Resistant Pathogens Behavioral: Workshops and focus group meetings Not Applicable

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:

  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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Change in Physicians' Prescribing Habits Decrease Carriage of Resistant Bacteria in the Community?
Study Start Date : February 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. antibiotic prescription rate of physicians [ Time Frame: 5 years ]
    Antibiotic prescrption rate at baseline will be compared to changes following the intervention between the 2 groups (control and intervention).


Secondary Outcome Measures :
  1. Carriage of antibiotic resistant bacteria by treated patients [ Time Frame: 4 years ]
    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.



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010

Keywords provided by Sheba Medical Center:
antibiotic use
antibiotic prescription
antibiotic resistant S. pneumoniae
MRSA

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents