COINCIDE: Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia

Sponsor
Erasmus Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05960084
Collaborator
Indonesia University (Other), Center For Indonesian Veterinary Analytical Studies (Other), Utrecht University (Other), Institute of Tropical Medicine (Other), University of Calgary (Other), Directorate of Veterinary Public Health, Ministry of Agriculture (Other)
803
1
22.3
36

Study Details

Study Description

Brief Summary

Colistin (polymyxin E) is considered a last resort antimicrobial for treatment of infections with multidrug- resistant bacteria, classified by WHO as 'highest prioritized, critically important for human medicine'. WHO suggests to ban or highly restrict its use in animals. In Indonesia, colistin resistance in human Escherichia coli isolates is poorly characterized as it requires specific non-routine tests. Presence of colistin resistance in E. coli in poultry resulted in a ban for livestock in Indonesia in 2020. However, colistin is still suspected to be routinely used in humans in multiple settings but the reasons for these practices are poorly understood. The ban on colistin use in livestock offers a unique opportunity to assess the impact of this intervention on colistin resistance in humans and animals, and how a One Health perspective can strengthen this intervention. This project aims to: i) determine phenotypic and genotypic colistin resistance in E. coli from humans and poultry in Indonesia;

  1. assess the impact of the colistin ban on resistance in E. coli in animals and humans;
  2. estimate the transmission of colistin resistance between animals and humans; iv) study colistin use and perceptions at the community level; and v) expand the initial colistin ban in the animal production sector into an integrative multi-sectorial One Health intervention, which will be designed and implemented using a community participatory approach. This project will provide a strong scientific basis to AMR policies in Indonesia, with great significance across Southeast Asia.
Condition or Disease Intervention/Treatment Phase
  • Other: screening

Study Design

Study Type:
Observational
Anticipated Enrollment :
803 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia
Anticipated Study Start Date :
Jul 23, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Prevalence of mcr-positive E. coli in humans in the community in Central Java, Indonesia [2024]

    Carriage of mcr-1 positive E. coli will be measured by taking rectal swabs of participants for bacterial culture.

  2. Risk factors associated with carriage of mcr-positive E. coli in humans [2024]

    Interviews based on structured close-ended questionnaires will be used. The questionnaire will include demographic data (gender, age) and possible risk factors (underlying diseases, certain habits as smoking, job, previous antibiotic use).

Secondary Outcome Measures

  1. Transmission of mcr-positive E. coli between farmers and poultry [2024]

    Transmission will be investigated by analyzing the mcr-positive E. coli with genomic analysis, such as whole genome sequencing.

  2. Overall antibiotic prescription behaviour in public health centers in Central Java, Indonesia [2024]

    Several methods will be used, including the drug-bag method, and collection of antibiotic prescription per public health center.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • All individuals with age >= 18 years old, that are willing to participate
Exclusion Criteria:
  • Vomiting and/or diarrhea

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, University of Indonesia Jakarta Indonesia

Sponsors and Collaborators

  • Erasmus Medical Center
  • Indonesia University
  • Center For Indonesian Veterinary Analytical Studies
  • Utrecht University
  • Institute of Tropical Medicine
  • University of Calgary
  • Directorate of Veterinary Public Health, Ministry of Agriculture

Investigators

  • Principal Investigator: Anis Karuniawati, MD PhD, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juliƫtte Severin, Associate professor, Medical coordinator Unit infection prevention, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT05960084
Other Study ID Numbers:
  • 22-03-0255
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juliƫtte Severin, Associate professor, Medical coordinator Unit infection prevention, Erasmus Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2023