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

Antimicrobial Resistance Clinical Trial

— COINCIDE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960084
• Other study ID #: 22-03-0255
• Status: Not yet recruiting
• Start date: July 23, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: Erasmus Medical Center
• Contact: Anis Karuniawati, MD PhD
• Phone: 62.21.3912477
• Email: anis.karuniawatimk[@]ui.ac.id
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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; 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 803
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Vomiting and/or diarrhea

Related Conditions & MeSH terms

• Antimicrobial Resistance
• Asymptomatic Infections
• Colistin

Intervention

Other:
• screening
screening for colistin resistant E. coli

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, University of Indonesia	Jakarta

Sponsors (7)

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

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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