NCT05652556

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

23 days

First QC Date

December 7, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

Escherichia coliStaphylococcus aureusFluoroquinolones

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Association of AMR and AMU data within and between the human health, animal health and aquaculture health sector in Blitar, for quinolones

    2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Culture of nasal and rectal swabs.

MeSH Terms

Conditions

Escherichia coli InfectionsStaphylococcal Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsGram-Positive Bacterial Infections

Study Officials

  • Juliëtte A. Severin, MD PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliëtte A. Severin, MD PhD

CONTACT

Tri Pudy Asmarawati, MD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Medical coordinator Unit infection prevention

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 15, 2022

Study Start

December 9, 2022

Primary Completion

January 1, 2023

Study Completion

March 31, 2023

Last Updated

December 15, 2022

Record last verified: 2022-12