Clinical trial NCT01187758: Israeli Judicious Antibiotic Prescription Study
Official title: Can Change in Physicians' Prescribing Habits Decrease Carriage of Resistant Bacteria in the Community?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Use
Carriage of Antibiotic Resistant Pathogens
Keywords: antibiotic use
antibiotic prescription
antibiotic resistant S. pneumoniae
MRSA
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2010-08-24
Enrollment: 5700
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: antibiotic prescription rate of physicians
timeFrame: 5 years
Secondary outcomes:
measure: Carriage of antibiotic resistant bacteria by treated patients
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
References:
citation: Regev-Yochay G, Raz M, Dagan R, Roizin H, Morag B, Hetman S, Ringel S, Ben-Israel N, Varon M, Somekh E, Rubinstein E. Reduction in antibiotic use following a cluster randomized controlled multifaceted intervention: the Israeli judicious antibiotic prescription study. Clin Infect Dis. 2011 Jul 1;53(1):33-41. doi: 10.1093/cid/cir272.