Resistance BacterialSmartAMRNCT06313619
Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program
A study testing SmartAMR in people with Resistance Bacterial and Increased Drug Resistance, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
We developed 'SmartAMR', a digital pharmacy system featuring real-time records, symptom checks, telemedicine, counselling, and medication reminders. This study aims to assess its feasibility, acceptability, and effectiveness within community pharmacy settings in Bangladesh. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resistance Bacterial, Increased Drug Resistance, Drug Resistance, Microbial
- What is being tested?
- SmartAMR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBangladesh
- Study dates
- 23 Oct 2023to 31 Oct 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years and above
- Registered drug seller/pharmacist
- Permanent residents of the study areas
- Willing to participate
Who cannot join
- Disoriented or critically ill
Trial locations and contacts
1 site in 1 country.
About this study
We developed 'SmartAMR', a digital pharmacy system featuring real-time records, symptom checks, telemedicine, counselling, and medication reminders. This study aims to assess its feasibility, acceptability, and effectiveness within community pharmacy settings in Bangladesh.
A before-after designed pilot quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample. For qualitative part, the sample will be selected purposively until data saturation and a total of 8 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding effectiveness, acceptability, adoption, feasibility, and cost of the intervention.
Read the detailed description
The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial resistance (AMR) is a global threat to human health. Even though the awareness of the potential threat from AMR is widespread, studies and monitoring programs describing the present situation are lacking. The presence of a 'pluralistic' health system and a large informal sector involving unqualified drug dispenser/providers/practitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country. An estimated 63% of antibiotic prescriptions are from unqualified providers. Besides, misconception about antibiotics is very common in Bangladesh. Meanwhile, the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain. Without adherence to national regulations, unnecessary and inappropriate prescriptions become common practice, particularly in rural areas. Domestic drug industries contribute to easily accessible and affordable drugs. To tackle this problem, prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS. Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices. Therefore, this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh, which were grouped into four interlinked areas - lack of awareness among patients/ consumers (demand side), perverse incentives and lack of knowledge among providers (supply side), poorly regulated pharmaceutical marketing and retail sales (regulatory side) and lack of data and research evidence to support awareness raising and policymaking (enabler).
This is a pioneering study in Bangladesh that introduces a comprehensive digital pharmacy management system, demonstrating its feasibility and acceptability while highlighting potential challenges. The intervention showed promise in improving record-keeping, raising awareness, and promoting rational antibiotic use. The cloud-based server of this system allows its integration with existing government data systems, providing it the privilege to scale up to a nationwide level and achieve sustainability. With adequate support and strategies to mitigate profit-driven noncompliance, such pharmacy-based interventions can play a vital role in national efforts to combat AMR.
The study is expected to bring light upon a comprehensive understanding of the current level of knowledge, perception and practice of irrational use of anti-microbials among target population. Furthermore, a digital intervention design will be produced and piloted to reduce irrational use of anti-microbials after considering its effectiveness. The wide range of the study findings will aid in assessing the acceptability, adoption, feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs.
- Being tested
- SmartAMR
- Keywords
- Anti-microbial resistance, Digital intervention, Irrational use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartAMRCombination product
"SmartAMR" is a digital system including a mobile app that helps keeping record of medicine sales, sending auto-generated messages to the consumers to remind them about medicine taking time and completing doses. It also poses a symptom checker driven by artificial intelligence and a telemedicine service.
| Study group | Role | What they receive |
|---|---|---|
| Digital Pharmacy Intervention | Experimental | A total of 39 pharmacy will be included in the intervention. The digital intervention named "SmartAMR" will be introduced among them. The participants will install the mobile app and use it to keep record of the antimicrobial sales in a central database. Receives: Combination Product: SmartAMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irrational usage of anti-microbials
Irrational usage of anti-microbials was demonstrated by number and pattern of purchasing of anti-microbials
Measured: 12 weeks
Acceptance rate
Number of pharmacy agreed and accepted the intervention and install the mobile app.
Measured: 12 weeks
Completion rate
The number of pharmacy who use the mobile app for the total duration of intervention.
Measured: 12 weeks
AMR Knowledge
Change in knowledge about antimicrobial resistance among the participants was assessed using a knowledge scale "AMR knowledge scale" that contained 31 questions. The score range will be 0 to 31, with greater score representing better knowledge.
Measured: Before and 12 weeks after the intervention
AMR attitude
Participants' attitude towards antimicrobial resistance was evaluated by a three-point Likert-type scale "AMR attitude scale", containing 14 attitude statements. The score range will be 14 to 42, with greater score representing better knowledge.
Measured: Before and 12 weeks after the intervention
AMR practice
Participants' practice regarding irrational antimicrobial usage is assessed by a practice scale "AMR practice scale", containing 9 items. Answers to the practice questions are taken on a rating scale (0=never; 1 = rarely; 2 = sometimes; 3 = frequently). Practice score ranges from 0 to 27. Higher score indicates better practice.
Measured: Before and 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start23 Oct 2023
- Primary completion30 Apr 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance BacterialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of pharmacy drug sellers were trained on using a digital pharmacy management system including record keeping, AI symptom checker, telemedicine services, counselling, and SMS reminder for dose completion.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Md Atiqul Haque, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- M Atiqul Haque, PhD, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313619
- Sponsor's protocol ID
- BSMMU/20236831
- Acronym
- SmartAMR
- Status last verified
- Aug 2025
- First submitted
- 25 Nov 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program
- ClinicalTrials.gov ID
- NCT06313619
- Acronym / sponsor ID
- SmartAMR / BSMMU/20236831
- Keywords
- Anti-microbial resistance, Digital intervention, Irrational use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 15 Mar 2024 (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.
We developed 'SmartAMR', a digital pharmacy system featuring real-time records, symptom checks, telemedicine, counselling, and medication reminders. This study aims to assess its feasibility, acceptability, and effectiveness within community pharmacy settings in Bangladesh.
A before-after designed pilot quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample. For qualitative part, the sample will be selected purposively until data saturation and a total of 8 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding effectiveness, acceptability, adoption, feasibility, and cost of the intervention.
Detailed description
The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial resistance (AMR) is a global threat to human health. Even though the awareness of the potential threat from AMR is widespread, studies and monitoring programs describing the present situation are lacking. The presence of a 'pluralistic' health system and a large informal sector involving unqualified drug dispenser/providers/practitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country. An estimated 63% of antibiotic prescriptions are from unqualified providers. Besides, misconception about antibiotics is very common in Bangladesh. Meanwhile, the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain. Without adherence to national regulations, unnecessary and inappropriate prescriptions become common practice, particularly in rural areas. Domestic drug industries contribute to easily accessible and affordable drugs. To tackle this problem, prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS. Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices. Therefore, this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh, which were grouped into four interlinked areas - lack of awareness among patients/ consumers (demand side), perverse incentives and lack of knowledge among providers (supply side), poorly regulated pharmaceutical marketing and retail sales (regulatory side) and lack of data and research evidence to support awareness raising and policymaking (enabler).
This is a pioneering study in Bangladesh that introduces a comprehensive digital pharmacy management system, demonstrating its feasibility and acceptability while highlighting potential challenges. The intervention showed promise in improving record-keeping, raising awareness, and promoting rational antibiotic use. The cloud-based server of this system allows its integration with existing government data systems, providing it the privilege to scale up to a nationwide level and achieve sustainability. With adequate support and strategies to mitigate profit-driven noncompliance, such pharmacy-based interventions can play a vital role in national efforts to combat AMR.
The study is expected to bring light upon a comprehensive understanding of the current level of knowledge, perception and practice of irrational use of anti-microbials among target population. Furthermore, a digital intervention design will be produced and piloted to reduce irrational use of anti-microbials after considering its effectiveness. The wide range of the study findings will aid in assessing the acceptability, adoption, feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of pharmacy drug sellers were trained on using a digital pharmacy management system including record keeping, AI symptom checker, telemedicine services, counselling, and SMS reminder for dose completion.
| Arm | Type | Receives |
|---|---|---|
| Digital Pharmacy Intervention | Experimental | Combination Product: SmartAMRA total of 39 pharmacy will be included in the intervention. The digital intervention named "SmartAMR" will be introduced among them. The participants will install the mobile app and use it to keep record of the antimicrobial sales in a central database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years and above
- Registered drug seller/pharmacist
- Permanent residents of the study areas
- Willing to participate
Key exclusion criteria (1 listed)
- Disoriented or critically ill
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 |
|---|---|---|
| SmartAMR"SmartAMR" is a digital system including a mobile app that helps keeping record of medicine sales, sending auto-generated messages to the consumers to remind them about medicine taking time and completing doses. It also poses a symptom checker driven by artificial intelligence and a telemedicine service. | Combination product | Digital Pharmacy Intervention |
Primary outcome
Irrational usage of anti-microbials
Time frame: 12 weeks
Irrational usage of anti-microbials was demonstrated by number and pattern of purchasing of anti-microbials
Acceptance rate
Time frame: 12 weeks
Number of pharmacy agreed and accepted the intervention and install the mobile app.
Completion rate
Time frame: 12 weeks
The number of pharmacy who use the mobile app for the total duration of intervention.
AMR Knowledge
Time frame: Before and 12 weeks after the intervention
Change in knowledge about antimicrobial resistance among the participants was assessed using a knowledge scale "AMR knowledge scale" that contained 31 questions. The score range will be 0 to 31, with greater score representing better knowledge.
AMR attitude
Time frame: Before and 12 weeks after the intervention
Participants' attitude towards antimicrobial resistance was evaluated by a three-point Likert-type scale "AMR attitude scale", containing 14 attitude statements. The score range will be 14 to 42, with greater score representing better knowledge.
AMR practice
Time frame: Before and 12 weeks after the intervention
Participants' practice regarding irrational antimicrobial usage is assessed by a practice scale "AMR practice scale", containing 9 items. Answers to the practice questions are taken on a rating scale (0=never; 1 = rarely; 2 = sometimes; 3 = frequently). Practice score ranges from 0 to 27. Higher score indicates better practice.
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
M Atiqul Haque, PhD study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartAMR in people with Resistance Bacterial and Increased Drug Resistance, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 8 Sep 2025. 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 Bangladesh. 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?
Irrational usage of anti-microbials (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 8 Sep 2025.