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Antibiotic Footprint Thailand - Pilot Questionnaire Study (AFT PILOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368768
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

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.


Condition or disease Intervention/treatment
Antibiotic Usage Other: Obtain inform consent via questionnaire of Monkey Survey

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Study Type : Observational
Actual Enrollment : 237 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Antibiotic Footprint Thailand - Pilot Questionnaire Study
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


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
Other: Obtain inform consent via questionnaire of Monkey Survey
This is an internet-based questionnaire study. Therefore, anyone in Thailand can access and answer the questionnaire.




Primary Outcome Measures :
  1. Total antibiotic usage in human population [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Association between the antibiotic usage and the episodes of common cold [ Time Frame: 1 year ]
    Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population

  2. Association between the antibiotic usage and the episodes of diarrhea [ Time Frame: 1 year ]
    Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Living in Thailand (staying in Thailand more than 6 months per year)
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

The participant may enter the study if ALL of the following apply:

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Male or female, aged 18 years or above.
  3. Living in Thailand (staying in Thailand more than 6 months per year)

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368768


Locations
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Thailand
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Thailand
Bangkok, Thailand, 10400
Sponsors and Collaborators
University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03368768     History of Changes
Other Study ID Numbers: MICRO1704
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Antimicrobial-resistant bacterial infection
Questionaire
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents