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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05960084
Recruitment Status : Not yet recruiting
First Posted : July 25, 2023
Last Update Posted : July 25, 2023
Sponsor:
Collaborators:
Indonesia University
Center For Indonesian Veterinary Analytical Studies
Utrecht University
Institute of Tropical Medicine
University of Calgary
Directorate of Veterinary Public Health, Ministry of Agriculture
Information provided by (Responsible Party):
Juliëtte Severin, Erasmus Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Colonization, Asymptomatic Colistin Mcr-1 Antimicrobial Resistance Other: screening

Study Design
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Study Type : Observational
Estimated Enrollment : 803 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia
Estimated Study Start Date : July 23, 2023
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Colistin

Groups and Cohorts
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Intervention Details:
  • Other: screening
    screening for colistin resistant E. coli

Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of mcr-positive E. coli in humans in the community in Central Java, Indonesia [ Time Frame: 2024 ]
    Carriage of mcr-1 positive E. coli will be measured by taking rectal swabs of participants for bacterial culture.

  2. Risk factors associated with carriage of mcr-positive E. coli in humans [ Time Frame: 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 :
  1. Transmission of mcr-positive E. coli between farmers and poultry [ Time Frame: 2024 ]
    Transmission will be investigated by analyzing the mcr-positive E. coli with genomic analysis, such as whole genome sequencing.

  2. Overall antibiotic prescription behaviour in public health centers in Central Java, Indonesia [ Time Frame: 2024 ]
    Several methods will be used, including the drug-bag method, and collection of antibiotic prescription per public health center.


Biospecimen Retention:   Samples With DNA
Bacterial DNA, particularly E. coli

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Vomiting and/or diarrhea
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05960084


Contacts
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Contact: Anis Karuniawati, MD PhD 62.21.3912477 anis.karuniawatimk@ui.ac.id

Locations
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Indonesia
Faculty of Medicine, University of Indonesia
Jakarta, Indonesia
Contact: Anis Karuniawati, MD, PhD    62.21.3912477    anis.karuniawatimk@ui.ac.id   
Principal Investigator: Anis Karuniawati, MD,PhD         
Sponsors and Collaborators
Erasmus Medical Center
Indonesia University
Center For Indonesian Veterinary Analytical Studies
Utrecht University
Institute of Tropical Medicine
University of Calgary
Directorate of Veterinary Public Health, Ministry of Agriculture
Investigators
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Principal Investigator: Anis Karuniawati, MD PhD Indonesia University
More Information
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Responsible Party: Juliëtte Severin, Associate professor, Medical coordinator Unit infection prevention, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT05960084    
Other Study ID Numbers: 22-03-0255
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juliëtte Severin, Erasmus Medical Center:
Escherichia coli
Additional relevant MeSH terms:
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Asymptomatic Infections
Infections
Asymptomatic Diseases
Disease Attributes
Pathologic Processes