Clinical trial NCT05652556: Quinolone Resistance Profiles and Mechanisms of Staphylococcus Aureus and Escherichia Coli From Humans, Chicken and Catfish Farms in Indonesia
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Resistance, Microbial
Keywords: Escherichia coli
Staphylococcus aureus
Fluoroquinolones
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dr. Soetomo General Hospital
name: Balai Besar Laboratorium Kesehatan (BBLK) Surabaya
name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
name: Directorate of Veterinary Public Health, Ministry of Agriculture, Indonesia
name: Directorate of Animal Health, Ministry of Agriculture, Indonesia
name: Ministry of Marine and Fisheries, Indonesia
name: Utrecht University
name: Radboud University Medical Center
name: National Institute for Public Health and the Environment (RIVM)
First posted: 2022-12-15
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Farmers of included farms and non-farmers. Non-farmers will be approached via public health center (puskesmas).

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Quinolone resistance profiles and mechanisms of S. aureus and E. coli in human health, animal health and aquaculture health sector in Blitar
timeFrame: 2023
Secondary outcomes:
measure: Association of AMR and AMU data within and between the human health, animal health and aquaculture health sector in Blitar, for quinolones
timeFrame: 2023
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus Medical Center
name: Juliëtte A. Severin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: