Antibiotic UsageAFT PILOTNCT03368768
Antibiotic Footprint Thailand - Pilot Questionnaire Study
An observational study of Antibiotic Usage, run by University of Oxford at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Usage
- What is being tested?
- Obtain inform consent via questionnaire of Monkey Survey
- How many people
- 237 participants
- Where
- 1 siteThailand
- Study dates
- 8 Feb 2017to 30 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Thailand
Bangkok, 10400
About this study
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.
- Conditions
- Antibiotic Usage
- Being tested
- Obtain inform consent via questionnaire of Monkey Survey
- Keywords
- Antimicrobial-resistant bacterial infection, Questionaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtain inform consent via questionnaire of Monkey SurveyOther
This is an internet-based questionnaire study. Therefore, anyone in Thailand can access and answer the questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Obtain inform consent via questionnaire of Monkey Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total antibiotic usage in human population
Measured: 1 year
Secondary outcomes (2)
Association between the antibiotic usage and the episodes of common cold
Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population
Measured: 1 year
Association between the antibiotic usage and the episodes of diarrhea
Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start8 Feb 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic UsageStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368768
- Sponsor's protocol ID
- MICRO1704
- Acronym
- AFT PILOT
- Status last verified
- Aug 2018
- First submitted
- 30 Oct 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Footprint Thailand - Pilot Questionnaire Study
- ClinicalTrials.gov ID
- NCT03368768
- Acronym / sponsor ID
- AFT PILOT / MICRO1704
- Conditions
- Antibiotic Usage
- Keywords
- Antimicrobial-resistant bacterial infection, Questionaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contact group email of Mahidol-Oxford Research Unit (MORU) | – | Other: Obtain inform consent via questionnaire of Monkey SurveyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obtain inform consent via questionnaire of Monkey SurveyThis is an internet-based questionnaire study. Therefore, anyone in Thailand can access and answer the questionnaire. | Other | Contact group email of Mahidol-Oxford Research Unit (MORU) |
Primary outcome
Total antibiotic usage in human population
Time frame: 1 year
2 secondary outcomes
Association between the antibiotic usage and the episodes of common cold
Time frame: 1 year
Association between the antibiotic usage and the episodes of diarrhea
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
Related trials for Antibiotic Usage
Recruiting
KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use - Comparing Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Use in Critically Ill Patients
Infection, Sepsis
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruiting
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
Recruiting
Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients
Diabetes Mellitus, Type 2, Pre-diabetes
Not yet recruitingObservational study
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Usage, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total antibiotic usage in human population (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.