Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program

Resistance Bacterial Clinical Trial

Official title:

Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313619
• Other study ID #: BSMMU/20236831
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: M Atiqul Haque, PhD
• Phone: +8801711428141
• Email: atiqulm26[@]bsmmu.edu.bd
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

A before-after designed 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 among the same participants 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 alongside a total of anticipated 6240 community dwellers. For qualitative part, the sample will be selected purposively until data saturation and a total of 20 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 acceptability, adoption, feasibility, and cost of the intervention.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years and above

• Registered drug seller/pharmacist

• Permanent residents of the study areas

• Willing to participate

Exclusion Criteria:

• Disoriented or critically ill

Related Conditions & MeSH terms

• Drug Resistance, Microbial
• Increased Drug Resistance
• Resistance Bacterial

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Bangladesh	Medicine Shop	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irrational usage of anti-microbials	Irrational usage of anti-microbials will be demonstrated by number and pattern of purchasing of anti-microbials	24 weeks
Primary	Acceptance rate	Number of pharmacy agreed and accepted the intervention and install the mobile app.	24 weeks
Primary	Completion rate	The number of pharmacy who use the mobile app for the total duration of intervention.	24 weeks