Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05652556 |
| Other study ID # |
QUINDO |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 9, 2022 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
December 2022 |
| Source |
Erasmus Medical Center |
| Contact |
Juliëtte A. Severin, MD PhD |
| Phone |
+31107033510 |
| Email |
j.severin[@]erasmusmc.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
