Quinolone Resistance Profiles and Mechanisms of Staphylococcus Aureus and Escherichia Coli From Humans, Chicken and Catfish Farms in Indonesia

NCT ID: NCT05652556

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-09

Study Completion Date

2023-03-31

Brief Summary

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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

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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

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Drug Resistance, Microbial

Keywords

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Escherichia coli Staphylococcus aureus Fluoroquinolones

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Informed consent

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Soetomo General Hospital

OTHER_GOV

Sponsor Role collaborator

Balai Besar Laboratorium Kesehatan (BBLK) Surabaya

UNKNOWN

Sponsor Role collaborator

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

OTHER

Sponsor Role collaborator

Directorate of Veterinary Public Health, Ministry of Agriculture, Indonesia

UNKNOWN

Sponsor Role collaborator

Directorate of Animal Health, Ministry of Agriculture, Indonesia

UNKNOWN

Sponsor Role collaborator

Ministry of Marine and Fisheries, Indonesia

UNKNOWN

Sponsor Role collaborator

Utrecht University

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

National Institute for Public Health and the Environment (RIVM)

OTHER_GOV

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Juliëtte Severin

Associate professor, Medical coordinator Unit infection prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juliëtte A. Severin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Central Contacts

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Juliëtte A. Severin, MD PhD

Role: CONTACT

Phone: +31107033510

Email: [email protected]

Tri Pudy Asmarawati, MD

Role: CONTACT

Phone: +62315018436

Email: [email protected]

Other Identifiers

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QUINDO

Identifier Type: -

Identifier Source: org_study_id