Colonization, AsymptomaticCOINCIDENCT05960084
Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia
An observational study of Colonization, Asymptomatic and Colistin, run by Erasmus Medical Center at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonization, Asymptomatic, Colistin, Mcr-1
- What is being tested?
- screening
- How many people
- 803 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Jul 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All individuals with age >= 18 years old, that are willing to participate
Who cannot join
- Vomiting and/or diarrhea
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, University of Indonesia
Jakarta
Anis Karuniawati, MD, PhD, 62.21.3912477, anis.karuniawatimk@ui.ac.id
Anis Karuniawati, MD,PhD
About this study
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
- Being tested
- screening
- Keywords
- Escherichia coli
- Medical subject headings
- Asymptomatic Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screeningOther
screening for colistin resistant E. coli
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 2024
Secondary outcomes (2)
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.
Measured: 2024
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.
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start23 Jul 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonization, AsymptomaticStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 803 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia, Center For Indonesian Veterinary Analytical Studies, Utrecht University, Institute of Tropical Medicine, University of Calgary, Directorate of Veterinary Public Health, Ministry of Agriculture
- Responsible party
- Principal investigator, Juliëtte Severin, Erasmus Medical Center
- Investigators
- Anis Karuniawati, MD PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960084
- Sponsor's protocol ID
- 22-03-0255
- Acronym
- COINCIDE
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia
- ClinicalTrials.gov ID
- NCT05960084
- Acronym / sponsor ID
- COINCIDE / 22-03-0255
- Conditions
- Colonization, Asymptomatic, Colistin, Mcr-1, Antimicrobial Resistance
- Keywords
- Escherichia coli
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 803 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Universitas Indonesia, Center For Indonesian Veterinary Analytical Studies, Utrecht University, Institute of Tropical Medicine, University of Calgary, Directorate of Veterinary Public Health, Ministry of Agriculture
- Study start
- 23 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All individuals with age >= 18 years old, that are willing to participate
Key exclusion criteria (1 listed)
- Vomiting and/or diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screeningscreening for colistin resistant E. coli | Other | – |
Primary outcome
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.
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).
2 secondary outcomes
Transmission of mcr-positive E. coli between farmers and poultry
Time frame: 2024
Overall antibiotic prescription behaviour in public health centers in Central Java, Indonesia
Time frame: 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anis Karuniawati, MD PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonization, Asymptomatic and Colistin, run by Erasmus Medical Center at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anis Karuniawati, MD PhD (62.21.3912477, anis.karuniawatimk@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of mcr-positive E. coli in humans in the community in Central Java, Indonesia (time frame: 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.