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

NCT05960084 | Unknown DMC

• 1 other identifier: 22-03-0255
• Study Type: observational
• Target: 803
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonization, Asymptomatic; Colistin; Mcr-1; Antimicrobial Resistance

Keywords

Escherichia coli

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Transmission of mcr-positive E. coli between farmers and poultry

  2024

• Overall antibiotic prescription behaviour in public health centers in Central Java, Indonesia

  2024

Interventions

screening OTHER

screening for colistin resistant E. coli

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Vomiting and/or diarrhea

Sponsors & Collaborators

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

Study Sites (1)

Faculty of Medicine, University of Indonesia

Jakarta, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA, particularly E. coli

MeSH Terms

Conditions

Asymptomatic Infections; Escherichia coli Infections

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Anis Karuniawati, MD PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anis Karuniawati, MD PhD

CONTACT

62.21.3912477; anis.karuniawatimk@ui.ac.id

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Medical coordinator Unit infection prevention

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 25, 2023
• Study Start: July 23, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

ID (1)