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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Resistance, Microbial

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 Type: Observational
• Enrollment (Anticipated): 480

Contacts and Locations

• Study Contact: Name: Juliëtte A. Severin, MD PhD; Phone Number: +31107033510; Email: j.severin@erasmusmc.nl
• Study Contact Backup: Name: Tri Pudy Asmarawati, MD; Phone Number: +62315018436; Email: tpasmarawati@fk.unair.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Farmers of included farms and non-farmers. Non-farmers will be approached via public health center (puskesmas).

Description

Inclusion Criteria:

• Informed consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2023

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Radboud University Medical Center; National Institute for Public Health and the Environment (RIVM); National Institute of Health Research and Development, Ministry of Health Republic of Indonesia; Utrecht University; Dr. Soetomo General Hospital; Balai Besar Laboratorium Kesehatan (BBLK) Surabaya; Directorate of Veterinary Public Health, Ministry of Agriculture, Indonesia; Directorate of Animal Health, Ministry of Agriculture, Indonesia; Ministry of Marine and Fisheries, Indonesia
• Investigators: Principal Investigator: Juliëtte A. Severin, MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 9, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Escherichia coli; Fluoroquinolones
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Escherichia coli Infections
• Other Study ID Numbers: QUINDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No