NCT01187758

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

3.7 years

First QC Date

August 23, 2010

Last Update Submit

August 23, 2010

Conditions

Keywords

antibiotic useantibiotic prescriptionantibiotic resistant S. pneumoniaeMRSA

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Carriage of antibiotic resistant bacteria by treated patients

    4 years

Study Arms (2)

Educational intervention

EXPERIMENTAL

Multifacet educational intervention that includes workshops, seminars and focus group meetings

Behavioral: Workshops and focus group meetings

Control - no intervention

NO INTERVENTION

This group did not have any intervention, but their population was screened for carriage of antibiotic resistant bacteria

Interventions

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

Educational intervention

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

February 1, 2002

Primary Completion

October 1, 2005

Study Completion

December 1, 2007

Last Updated

August 24, 2010

Record last verified: 2010-08