- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368768
Antibiotic Footprint Thailand - Pilot Questionnaire Study (AFT PILOT)
Antimicrobial-resistant bacterial infection is an important cause of death in Thailand and in other countries worldwide. Increasing use of antibiotics in both animals and humans is one of the main drive that increase the incidence of antimicrobial resistant bacteria in human, animals and environment.
National Action Plan for Combating Antibiotic-resistant Bacteria aimed to have general population taking antibiotics less than 20% when they have common cold or diarrheal symptoms. However, there is little accurate information about behaviors of Thai people. Most studies were conducted in hospitals, clinics or pharmacy. Therefore, it did not include behaviors of those who had symptoms but did not present at hospitals, clinics or pharmacy.
In this study, the investigators aim to use questionnaire to Thai adult population to ask for the the amount of antibiotic used and the periods they had symptoms of common cold or diarrhea over one year period of year 2017. The main aim is to estimate the total antibiotic usage per human population, and plan for the study in the future.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10400
- Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This study aims to have at least 100 adult people who could provide information for the total of one year. This expects that at least 20 of those 100 people would have common cold or diarrhea at least one time over one year period. This should provide more than 80% power to detect whether the proportion of having antibiotics when they have common cold or diarrhea was lower than 50% or not. The hypothesizjed proportion was 20% as stated by the national strategy against AMR in Thailand.
MORU has a total number of staff for more than 200 people, and we suspect that the internal people in MORU should be enough for the study. We will also want to pilot whether the internet-based study can spread into the community well or not.
Description
Inclusion Criteria:
The participant may enter the study if ALL of the following apply:
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Living in Thailand (staying in Thailand more than 6 months per year)
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Contact group email of Mahidol-Oxford Research Unit (MORU)
The investigator aims to have at least 100 adult people who could provide information for the total of one year.
This expects that at least 20 of those 100 people would have common cold or diarrhea at least one time over one year period.
This should provide more than 80% power to detect whether the proportion of having antibiotics when they have common cold or diarrhea was lower than 50% or not.
The hypothesized proportion was 20% as stated by the national strategy against AMR in Thailand
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This is an internet-based questionnaire study.
Therefore, anyone in Thailand can access and answer the questionnaire.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Total antibiotic usage in human population
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between the antibiotic usage and the episodes of common cold
Time Frame: 1 year
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Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population
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1 year
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Association between the antibiotic usage and the episodes of diarrhea
Time Frame: 1 year
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Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MICRO1704
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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