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

Sponsor
Erasmus Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05652556
Collaborator
Dr. Soetomo General Hospital (Other), Balai Besar Laboratorium Kesehatan (BBLK) Surabaya (Other), National Institute of Health Research and Development, Ministry of Health Republic of Indonesia (Other), Directorate of Veterinary Public Health, Ministry of Agriculture, Indonesia (Other), Directorate of Animal Health, Ministry of Agriculture, Indonesia (Other), Ministry of Marine and Fisheries, Indonesia (Other), Utrecht University (Other), Radboud University Medical Center (Other), National Institute for Public Health and the Environment (RIVM) (Other)
480
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    480 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    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
    Anticipated Study Start Date :
    Dec 9, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Mar 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Quinolone resistance profiles and mechanisms of S. aureus and E. coli in human health, animal health and aquaculture health sector in Blitar [2023]

      As determined by Vitek, microdilution, and whole genome sequencing.

    Secondary Outcome Measures

    1. Association of AMR and AMU data within and between the human health, animal health and aquaculture health sector in Blitar, for quinolones [2023]

      Based on questionnaires

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Informed consent
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Erasmus Medical Center
    • 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)

    Investigators

    • Principal Investigator: Juliëtte A. Severin, MD PhD, Erasmus Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Juliëtte Severin, Associate professor, Medical coordinator Unit infection prevention, Erasmus Medical Center
    ClinicalTrials.gov Identifier:
    NCT05652556
    Other Study ID Numbers:
    • QUINDO
    First Posted:
    Dec 15, 2022
    Last Update Posted:
    Dec 15, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Juliëtte Severin, Associate professor, Medical coordinator Unit infection prevention, Erasmus Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 15, 2022