Drug Resistance, MicrobialQUINDONCT05652556
Quinolone Resistance Profiles and Mechanisms of Staphylococcus Aureus and Escherichia Coli From Humans, Chicken and Catfish Farms in Indonesia
An observational study of Drug Resistance, Microbial, run by Erasmus Medical Center.
Trial summary
The goal of this observational study is to reveal quinolone resistance profiles and mechanisms in S. aureus and E. coli in the human, animal and aquaculture sector in Blitar, Indonesia. The main questions it aims to answer are: Obtain the quinolone resistance profiles and mechanisms of S. aureus and E. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Resistance, Microbial
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2022to 31 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Farmers of included farms and non-farmers. Non-farmers will be approached via public health center (puskesmas).
Who may be able to join
- Informed consent
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Quinolone Resistance Profiles and Mechanisms of Staphylococcus Aureus and Escherichia Coli From Humans, Chicken and Catfish Farms With a One Health Approach in Blitar, East Java Province, Indonesia
The goal of this observational study is to reveal quinolone resistance profiles and mechanisms in S. aureus and E. coli in the human, animal and aquaculture sector in Blitar, Indonesia.
The main questions it aims to answer are:
- Obtain the quinolone resistance profiles and mechanisms of S. aureus and E. coli in human health, animal health and aquaculture health sector in Blitar, Indonesia.
- Obtain the association of AMR and AMU data within and between the human health, animal health and aquaculture health sector in Blitar, for quinolones.
Read the detailed description
Antimicrobial resistance (AMR) has become a global threat in public health. It is mainly driven by antimicrobial use (AMU), not only in the human sector, but also in the animal and aquaculture sector. In aquaculture and terrestrial animals, antibiotics have been used as growth promoters as well as for prophylaxis and treatment for infection. It has been used on a large scale as a supplement to increase animal production in over 60 years. During the last decade, there has been an increasing antimicrobial resistance in the community regarding resistance to carbapenems, 3rd generation cephalosporins and quinolones. The World Health Organization categorized carbapenems, 3rd generation cephalosporins and quinolones as "Watch antibiotics" and these should be used with caution because of their high effects and their high potential to cause the development of AMR in many countries.
The quinolones are broad-spectrum antibiotics that are probably one of the most widely used drugs for the treatment of several community and hospital-acquired infections in the human health sector. It is also used in aquaculture and agricultural fields, for instance in chicken farms. The use of quinolones and other "Watch antibiotics" in many countries monitored by the World Health Organization since 2016 varies a lot and ranges from less than 20% to more than 50%.
It is well documented that several pathogenic bacteria have developed resistance as a consequence of exposure to the antimicrobials. Resistant bacteria can spread to humans directly from the food chain, and indirectly from the environmental pollution of farm effluents. This study will reveal quinolone resistance profiles and mechanisms in S. aureus and E. coli in the human, animal and aquaculture sector in Blitar, Indonesia.
Population The research populations are residents (farmers and non-farmers) in Kabupaten Blitar.
Sample
Layer farm:
Samples will be taken in layer farms in the Blitar region. The type of sample will be bootswab samples as published before; 25 E. coli isolates/farm will be collected. A total of 30 farms will be included.
Aquaculture sample:
Aquaculture samples will be taken from catfish ponds in several regions in Kabupaten Blitar. One sample of water or mud of one pond will be taken (the pond closest to the entrance). From this sample, 5 E. coli will be isolated.
Human sample:
Human samples will be taken from people on layer and aquaculture farms (farmers, farmworkers and family members of farmers), and non-farmer residents of several regions in Kabupaten Blitar. Nasal (S. aureus) and rectal (E. coli) samples will be taken after informed consent. AMU data will be collected via questionnaires.
- Conditions
- Drug Resistance, Microbial
- Keywords
- Escherichia coli, Staphylococcus aureus, Fluoroquinolones
- Medical subject headings
- Escherichia coli Infections, Staphylococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Quinolone resistance profiles and mechanisms of S. aureus and E. coli in human health, animal health and aquaculture health sector in Blitar
As determined by Vitek, microdilution, and whole genome sequencing.
Measured: 2023
Secondary outcomes (1)
Association of AMR and AMU data within and between the human health, animal health and aquaculture health sector in Blitar, for quinolones
Based on questionnaires
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start9 Dec 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistance, MicrobialStudies 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Soetomo General Hospital, Balai Besar Laboratorium Kesehatan (BBLK) Surabaya, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, Directorate of Veterinary Public Health, Ministry of Agriculture, Indonesia, Directorate of Animal Health, Ministry of Agriculture, Indonesia, Ministry of Marine and Fisheries, Indonesia, Utrecht University, Radboud University Medical Center, National Institute for Public Health and the Environment (RIVM)
- Responsible party
- Principal investigator, Juliëtte Severin, Erasmus Medical Center
- Investigators
- Juliëtte A. Severin, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652556
- Sponsor's protocol ID
- QUINDO
- Acronym
- QUINDO
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quinolone Resistance Profiles and Mechanisms of Staphylococcus Aureus and Escherichia Coli From Humans, Chicken and Catfish Farms With a One Health Approach in Blitar, East Java Province, Indonesia
- ClinicalTrials.gov ID
- NCT05652556
- Acronym / sponsor ID
- QUINDO / QUINDO
- Conditions
- Drug Resistance, Microbial
- Keywords
- Escherichia coli, Staphylococcus aureus, Fluoroquinolones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dr. Soetomo General Hospital, Balai Besar Laboratorium Kesehatan (BBLK) Surabaya, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, Directorate of Veterinary Public Health, Ministry of Agriculture, Indonesia, Directorate of Animal Health, Ministry of Agriculture, Indonesia, Ministry of Marine and Fisheries, Indonesia, Utrecht University, Radboud University Medical Center, National Institute for Public Health and the Environment (RIVM)
- Study start
- 9 Dec 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 15 Dec 2022 (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.
The goal of this observational study is to reveal quinolone resistance profiles and mechanisms in S. aureus and E. coli in the human, animal and aquaculture sector in Blitar, Indonesia.
The main questions it aims to answer are:
- Obtain the quinolone resistance profiles and mechanisms of S. aureus and E. coli in human health, animal health and aquaculture health sector in Blitar, Indonesia.
- Obtain the association of AMR and AMU data within and between the human health, animal health and aquaculture health sector in Blitar, for quinolones.
Detailed description
Antimicrobial resistance (AMR) has become a global threat in public health. It is mainly driven by antimicrobial use (AMU), not only in the human sector, but also in the animal and aquaculture sector. In aquaculture and terrestrial animals, antibiotics have been used as growth promoters as well as for prophylaxis and treatment for infection. It has been used on a large scale as a supplement to increase animal production in over 60 years. During the last decade, there has been an increasing antimicrobial resistance in the community regarding resistance to carbapenems, 3rd generation cephalosporins and quinolones. The World Health Organization categorized carbapenems, 3rd generation cephalosporins and quinolones as "Watch antibiotics" and these should be used with caution because of their high effects and their high potential to cause the development of AMR in many countries.
The quinolones are broad-spectrum antibiotics that are probably one of the most widely used drugs for the treatment of several community and hospital-acquired infections in the human health sector. It is also used in aquaculture and agricultural fields, for instance in chicken farms. The use of quinolones and other "Watch antibiotics" in many countries monitored by the World Health Organization since 2016 varies a lot and ranges from less than 20% to more than 50%.
It is well documented that several pathogenic bacteria have developed resistance as a consequence of exposure to the antimicrobials. Resistant bacteria can spread to humans directly from the food chain, and indirectly from the environmental pollution of farm effluents. This study will reveal quinolone resistance profiles and mechanisms in S. aureus and E. coli in the human, animal and aquaculture sector in Blitar, Indonesia.
Population The research populations are residents (farmers and non-farmers) in Kabupaten Blitar.
Sample
Layer farm:
Samples will be taken in layer farms in the Blitar region. The type of sample will be bootswab samples as published before; 25 E. coli isolates/farm will be collected. A total of 30 farms will be included.
Aquaculture sample:
Aquaculture samples will be taken from catfish ponds in several regions in Kabupaten Blitar. One sample of water or mud of one pond will be taken (the pond closest to the entrance). From this sample, 5 E. coli will be isolated.
Human sample:
Human samples will be taken from people on layer and aquaculture farms (farmers, farmworkers and family members of farmers), and non-farmer residents of several regions in Kabupaten Blitar. Nasal (S. aureus) and rectal (E. coli) samples will be taken after informed consent. AMU data will be collected via questionnaires.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Farmers of included farms and non-farmers. Non-farmers will be approached via public health center (puskesmas).
Key inclusion criteria (1 listed)
- Informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quinolone resistance profiles and mechanisms of S. aureus and E. coli in human health, animal health and aquaculture health sector in Blitar
Time frame: 2023
As determined by Vitek, microdilution, and whole genome sequencing.
1 secondary outcome
Association of AMR and AMU data within and between the human health, animal health and aquaculture health sector in Blitar, for quinolones
Time frame: 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: Undecided. Undecided yet.
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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.
Juliëtte A. Severin, MD PhD principal investigator
Erasmus Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistance, Microbial, run by Erasmus Medical Center.
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 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Juliëtte A. Severin, MD PhD (+31107033510, j.severin@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quinolone resistance profiles and mechanisms of S. aureus and E. coli in human health, animal health and aquaculture health sector in Blitar (time frame: 2023). 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 15 Dec 2022.