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

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; ii) assess the impact of the colistin ban on resistance in E. coli in animals and humans; iii) 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Antimicrobial Resistance; Colonization, Asymptomatic; Colistin; Mcr-1
• Intervention / Treatment: Other: screening

• Study Type: Observational
• Enrollment (Estimated): 803

Contacts and Locations

• Study Contact: Name: Anis Karuniawati, MD PhD; Phone Number: 62.21.3912477; Email: anis.karuniawatimk@ui.ac.id

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Faculty of Medicine, University of Indonesia
    • Contact: Anis Karuniawati, MD, PhD; Phone Number: 62.21.3912477; Email: anis.karuniawatimk@ui.ac.id
    • Principal Investigator: Anis Karuniawati, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Local public health centers (Puskesmas) will be recruiting participants and sampling in the three districts of Central Java in Indonesia: Sukoharjo, Klaten, and Karanganyar. The targeted study participants are individuals at least 18 years old without any diarrhea and/or vomiting at the time of visit to local public health centers. In addition, poultry farms will be approached for sampling in the same area.

Description

Inclusion Criteria:

• All individuals with age >= 18 years old, that are willing to participate

Exclusion Criteria:

• Vomiting and/or diarrhea

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of mcr-positive E. coli in humans in the community in Central Java, Indonesia	Carriage of mcr-1 positive E. coli will be measured by taking rectal swabs of participants for bacterial culture.	2024
Risk factors associated with carriage of mcr-positive E. coli in humans	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).	2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transmission of mcr-positive E. coli between farmers and poultry	Transmission will be investigated by analyzing the mcr-positive E. coli with genomic analysis, such as whole genome sequencing.	2024
Overall antibiotic prescription behaviour in public health centers in Central Java, Indonesia	Several methods will be used, including the drug-bag method, and collection of antibiotic prescription per public health center.	2024

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: University of Calgary; Institute of Tropical Medicine; Indonesia University; Utrecht University; Center For Indonesian Veterinary Analytical Studies; Directorate of Veterinary Public Health, Ministry of Agriculture
• Investigators: Principal Investigator: Anis Karuniawati, MD PhD, Indonesia University

Study record dates

Study Major Dates

• Study Start (Estimated): July 23, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Escherichia coli
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Asymptomatic Diseases; Asymptomatic Infections
• Other Study ID Numbers: 22-03-0255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study will be carried our according to the principles states in the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects), all applicable regulations and according to established international and national scientific standards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No