Clinical trial NCT05960084: Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia
Official title: Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colonization, Asymptomatic
Colistin
Mcr-1
Antimicrobial Resistance
Keywords: Escherichia coli
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Indonesia University
name: Center For Indonesian Veterinary Analytical Studies
name: Utrecht University
name: Institute of Tropical Medicine
name: University of Calgary
name: Directorate of Veterinary Public Health, Ministry of Agriculture
First posted: 2023-07-25
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Vomiting and/or diarrhea

Primary outcomes:
measure: Prevalence of mcr-positive E. coli in humans in the community in Central Java, Indonesia
timeFrame: 2024
measure: Risk factors associated with carriage of mcr-positive E. coli in humans
timeFrame: 2024
Secondary outcomes:
measure: Transmission of mcr-positive E. coli between farmers and poultry
timeFrame: 2024
measure: Overall antibiotic prescription behaviour in public health centers in Central Java, Indonesia
timeFrame: 2024
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Faculty of Medicine, University of Indonesia
Study officials:
affiliation: Indonesia University
name: Anis Karuniawati, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: