Preventing antimicrobial resistance by promoting appropriate prescription of antibiotics, for acute respiratory infections and diarrhoea among adolescents and adults, at rural health centers in Punjab, Pakistan
| ISRCTN | ISRCTN32235505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32235505 |
| Secondary identifying numbers | 100023 |
- Submission date
- 03/09/2024
- Registration date
- 09/09/2024
- Last edited
- 17/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Backgrounds and study aim
The aim of this trial is to assess the effectiveness of a contextualized intervention, including training and a training manual and desk guide for healthcare staff, to reduce the number of irrational antibiotic prescriptions for upper respiratory tract infections and diarrheal conditions at rural health centers in Punjab, Pakistan.
Who can participate?
Patients aged 12 years and over diagnosed with upper respiratory tract infection or diarrhoea
What does the study involve?
Rural health centers are randomly allocated to the control group or the intervention group.
In the control group the treatment of acute upper respiratory tract infection and diarrhoea will be continued as per routine.
However, to ensure comparability, both in the intervention and control groups, the doctors and allied healthcare staff will be trained to diagnose the patients coming with URTI or diarrhoea according to the case definitions used in the trial. The staff will also be trained in routine patient record-keeping. Patients with symptoms of URTI or diarrhoea will get a WhatsApp number to report the occurrence of significant medical conditions with the help of simplified coding.
The intervention group will be strengthened with a contextualized care package for URTI and diarrhoea which will include a desk guide for the doctors, training modules for doctors and allied staff and a digital application to support patient engagement.
Data will be collected at two distinct time points: firstly, at baseline (February 2025), and subsequently at the end line (March 2026).
What are the possible benefits and risks of participating?
Though there are no immediate benefits for those people participating in the project, it is expected that this work will reduce the practices of inappropriate antibiotic prescriptions amongst healthcare providers and promote responsible consumption within the community. There are no potential risks or disadvantages to participating in the study.
Where is the study run from?
Association for Social Development (Pakistan)
When is the study starting and how long is it expected to run for?
September 2024 to June 2026
Who is funding the study?
International Centre for Antimicrobial Resistance Solutions (Denmark)
Who is the main contact?
Muhammad Amir Khan, ccp@asd.com.pk
Contact information
Public, Scientific, Principal Investigator
House 12, street 48, F-7/4
Islamabad
04409
Pakistan
| Phone | +92 (0)51 2611230 3 |
|---|---|
| ccp@asd.com.pk |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A cluster randomized controlled trial to promote appropriate antibiotic prescriptions at rural health centers in Punjab, Pakistan |
| Study objectives | The contextual intervention at the Rural Health Centers of Punjab will be effective in reducing inappropriate antibiotic prescriptions by 15%. |
| Ethics approval(s) |
1. Approved 03/09/2024, Association For Social Development (House 12, street 48, F-7/4, Islamabad, 04409, Pakistan; +92 (0)3005191866; irb@asd.com.pk), ref: ASD-EAG-24-002 2. Approved 29/01/2025, Research Ethics Committee for School of Medicine (Governance and Compliance, 11-14 Blenheim Terrace, University of Leeds, Leeds, LS2 9HZ, United Kingdom; +44 (0)113 2431751; FMHUniEthics@leeds.ac.uk), ref: 2247 |
| Health condition(s) or problem(s) studied | Diarrhea and upper respiratory tract infections |
| Intervention | In the control arm the treatment of acute upper respiratory tract infection and diarrhoea will be continued as per routine. However, to ensure comparability, both in intervention and control arms, the doctors and allied healthcare staff will be trained to diagnose the patients coming with URTI or diarrhoea according to the case definitions used in the trial. The staff will also be trained in routine patient record-keeping. The patient with symptoms of URTI or diarrhoea will get a WhatsApp number to report the occurrence of significant medical conditions with the help of simplified coding. The intervention arm will be strengthened with a contextualized care package for URTI and diarrhoea which will include a desk guide for the doctors, training modules for doctors and allied staff and a digital application (i.e., Engage ALL-AMR) to support patient engagement. Randomization: The study will recruit and randomize the required sample size of 30 rural health centers (RHCs) in three districts of rural Punjab, i.e., Jhang, Muzaffargarh and Sargodha. All ten RHCs in each district will be allocated into intervention and control at a 1:1 ratio using the randomizeR package in R software. |
| Intervention type | Other |
| Primary outcome measure | The effectiveness of the intervention measured by calculating the proportion of upper respiratory tract infection (URTI)/diarrhea patients getting inappropriate antibiotic prescriptions in the intervention and control arms. This will be a binary outcome variable stating whether the antibiotic prescription is appropriate or inappropriate. This outcome measure will actually be presented as a proportion and percentage change in the appropriate antibiotic prescription among intervention and control arms. The outcome will be assessed exactly 1 year after the intervention, which is known as endline assessment. |
| Secondary outcome measures | The subgroups of diarrhea and URTI patients getting inappropriate antibiotic prescription in the intervention and control arms. Upon collecting all the data, the researchers will stratify the dataset into two subgroups: patients diagnosed with upper respiratory tract infections and/or those diagnosed with diarrhea. The effectiveness of the intervention will be evaluated within both subgroups. The assessment is planned for the first quarter of 2026 (January to March). |
| Overall study start date | 03/09/2024 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Sex | Both |
| Target number of participants | 600 each at baseline and endline (300 intervention arm and 300 control arm) |
| Key inclusion criteria | Cluster level: 1. The top 10 rural health centers per district with the best annual OPD attendance will be included in this study Patient level: 1. 12 or more years of age 2. Upper respiratory tract infections and/or acute diarrhea based on clinical case definitions 3. Voluntarily accepts the study’s informed consent and age-appropriate parental consent form |
| Key exclusion criteria | 1. Chronic diarrheal disease 2. Diagnosed as any other lung condition except URTI 3. Severe conditions requiring (inpatient) hospital attention 4. Failure to provide consent |
| Date of first enrolment | 20/02/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
Islamabad
04409
Pakistan
Sponsor information
Research organisation
Ørestads Boulevard 5
Copenhagen
2300 Copenhagen S
Denmark
| Phone | DK 42047007 |
|---|---|
| ericaw@icars-global.org | |
| Website | https://www.icars-global.org |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | For in-country dissemination, the researchers will focus on facilitating the decision-making for public-funded scaling in the province. They will rely mainly on our tested approach i.e., stakeholder consultation for evidence-informed decisions on possible scaling; followed by technical assistance for the public partner to mobilize public endorsement and resources, as deemed needed, for implementing the agreed scaling decisions. For wider dissemination, the researchers will: a) draft a scientific paper on trial results) for publication in reputable peer-reviewed and open-access journals; and b) present in relevant national and international event(s). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository; Research Data Leeds Repository (https://archive.researchdata.leeds.ac.uk/) |
Editorial Notes
17/03/2025: The following changes were made:
1. Ethics approval from the University of Leeds was added.
2. The recruitment start date was changed from 01/12/2024 to 20/02/2025.
3. The recruitment end date was changed from 31/12/2025 to 31/03/2026.
4. The overall end date was changed from 31/03/2026 to 30/06/2026.
5. The Individual participant data (IPD) sharing plan and summary were added.
6. The intention to publish date was changed from 31/01/2026 to 31/05/2026.
06/09/2024: Study's existence confirmed by the Directorate General of Health Services Punjab.
