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

Not yet recruiting

• Conditions: Colistin; Antimicrobial Resistance; Colonization, Asymptomatic; Mcr-1

• Registration Number: NCT05960084
• Lead Sponsor: Erasmus Medical Center

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; 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-16
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study Start: 2023-07-23
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 803

Inclusion Criteria

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

Exclusion Criteria

• Vomiting and/or diarrhea

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Faculty of Medicine, University of Indonesia; 🇮🇩 Jakarta, Indonesia