NCT05090475

Brief Summary

World increase in mortality from consequences of antimicrobial resistance (AMR) represents a significant public health problem. Irrational prescribing of antimicrobial drugs (AMD) in general population is one of the main causes of development AMR. This is also contributed by fact that up to 90% of total antimicrobial consumption in Europe is related to the general population. Problem of AMR has been recognized by World Health Organization and Council of European Union, which support the establishment of the antimicrobial stewardship team (A-team). A-team provides co-ordinated interventions that promote rational use of AMD. To date, no study has been carried out in which A-team from hospital environment goes to primary health care for the purpose of rationalization prescribing of AMD by primary health care practitioners. Project for implementation of hospital A-team in primary health care in Koprivnica-Križevci County was initiated using academic detailing method aimed at rationalization of the consumption of AMD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

29 days

First QC Date

July 6, 2021

Last Update Submit

December 28, 2023

Conditions

Keywords

Antimicrobial resistanceHospital A-teamAcademic detailing interventionAntimicrobial prescribingPrimary care

Outcome Measures

Primary Outcomes (1)

  • Proportion of antimicrobials expressed as DDD per day for ATC group J01 associated with acute respiratory tract infections

    Rationalization of consumption of antimicrobials for acute respiratory tract infections (for associated ICD diagnoses J01, J02, J03, J06, J20)

    1 year

Secondary Outcomes (1)

  • Change in Clostridiodes dificile infection for patients on antimicrobial therapy

    1 year

Study Arms (3)

Experimental group in Koprivnica Križevci County

EXPERIMENTAL

Hospital A-team provided academic detailing intervention to primary care physicians in Koprivnica Križevci county who agree to participate

Behavioral: Academic detailing intervention

Control group in Koprivnica Križevci county

NO INTERVENTION

Primary care physicians in Koprivnica Križevci county who did not agree to participate in academic detailing intervention

Control group in Bjelovar Bilogora county

NO INTERVENTION

Primary care physicians in Bjelovar Bilogora county without the academic detailing intervention

Interventions

Academic detailing or educational outreach is a method based on scientific data with the help of educated A-team members in the form of direct (face-to-face) interactions, prescribing practices change and adherence improves according to the application of currently valid therapeutic guidelines

Experimental group in Koprivnica Križevci County

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All primary care physicians in Koprivnica Križevci County that agree to participate in the study

You may not qualify if:

  • Primary care physicians outside Koprivnica Križevci County

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koprivnica križevci county

Koprivnica, Koprivnica-Križevci County, 48000, Croatia

Location

Related Publications (12)

  • Bryce A, Hay AD, Lane IF, Thornton HV, Wootton M, Costelloe C. Global prevalence of antibiotic resistance in paediatric urinary tract infections caused by Escherichia coli and association with routine use of antibiotics in primary care: systematic review and meta-analysis. BMJ. 2016 Mar 15;352:i939. doi: 10.1136/bmj.i939.

    PMID: 26980184BACKGROUND
  • Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.

    PMID: 20483949BACKGROUND
  • Marquet K, Liesenborgs A, Bergs J, Vleugels A, Claes N. Incidence and outcome of inappropriate in-hospital empiric antibiotics for severe infection: a systematic review and meta-analysis. Crit Care. 2015 Feb 16;19(1):63. doi: 10.1186/s13054-015-0795-y.

    PMID: 25888181BACKGROUND
  • Teillant A, Gandra S, Barter D, Morgan DJ, Laxminarayan R. Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA: a literature review and modelling study. Lancet Infect Dis. 2015 Dec;15(12):1429-37. doi: 10.1016/S1473-3099(15)00270-4. Epub 2015 Oct 22.

    PMID: 26482597BACKGROUND
  • Bassetti M, Righi E. Development of novel antibacterial drugs to combat multiple resistant organisms. Langenbecks Arch Surg. 2015 Feb;400(2):153-65. doi: 10.1007/s00423-015-1280-4. Epub 2015 Feb 11.

    PMID: 25667169BACKGROUND
  • Gundlapalli AV, Beekmann SE, Graham DR, Polgreen PM; Members of the Emerging Infections Network. Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians. Open Forum Infect Dis. 2018 Apr 23;5(4):ofy068. doi: 10.1093/ofid/ofy068. eCollection 2018 Apr.

    PMID: 29732380BACKGROUND
  • Nellums LB, Thompson H, Holmes A, Castro-Sanchez E, Otter JA, Norredam M, Friedland JS, Hargreaves S. Antimicrobial resistance among migrants in Europe: a systematic review and meta-analysis. Lancet Infect Dis. 2018 Jul;18(7):796-811. doi: 10.1016/S1473-3099(18)30219-6. Epub 2018 May 17.

    PMID: 29779917BACKGROUND
  • Chitnis AS, Holzbauer SM, Belflower RM, Winston LG, Bamberg WM, Lyons C, Farley MM, Dumyati GK, Wilson LE, Beldavs ZG, Dunn JR, Gould LH, MacCannell DR, Gerding DN, McDonald LC, Lessa FC. Epidemiology of community-associated Clostridium difficile infection, 2009 through 2011. JAMA Intern Med. 2013 Jul 22;173(14):1359-67. doi: 10.1001/jamainternmed.2013.7056.

    PMID: 23780507BACKGROUND
  • Avorn J, Soumerai SB. Improving drug-therapy decisions through educational outreach. A randomized controlled trial of academically based "detailing". N Engl J Med. 1983 Jun 16;308(24):1457-63. doi: 10.1056/NEJM198306163082406.

    PMID: 6406886BACKGROUND
  • Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.

    PMID: 2104640BACKGROUND
  • O'Brien MA, Rogers S, Jamtvedt G, Oxman AD, Odgaard-Jensen J, Kristoffersen DT, Forsetlund L, Bainbridge D, Freemantle N, Davis DA, Haynes RB, Harvey EL. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD000409. doi: 10.1002/14651858.CD000409.pub2.

    PMID: 17943742BACKGROUND
  • Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

    PMID: 26864410BACKGROUND

Related Links

MeSH Terms

Conditions

Respiratory Tract InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Darija Kuruc Poje

    General Hospital Koprivnica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of hospital pharmacy, Clinical pharmacist

Study Record Dates

First Submitted

July 6, 2021

First Posted

October 22, 2021

Study Start

April 1, 2020

Primary Completion

April 30, 2020

Study Completion

December 31, 2022

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Just IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations