Drug UseE-PAUseNCT06135376
E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting
A study testing comprehensive multi-component interventions in people with Drug Use, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Specific Aim 1: To determine the knowledge, attitude, and practice (KAP) of PHCC physicians regarding appropriate prescription of antibiotics in the outpatient setting. Hypothesis 1a: PHCC physicians will have adequate theoretical knowledge regarding use of antibiotics for upper respiratory tract infections. Read more about this study
- Who is it for?
- Ages 2 to 120 years
- Conditions the study is for
- Drug Use
- What is being tested?
- comprehensive multi-component interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteQatar
- Study dates
- 1 Dec 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients >2 years old presenting to any of the selected PHCCs (rationale: signs and symptoms of bacterial infection in very young children are more non-specific and empiric antibiotics are often indicated due to serious consequences of unrecognized and untreated bacterial infections)
- Presenting with acute (<1 week of symptoms) upper respiratory tract infection (URTI) like illness including
- common cold/acute rhinitis/nasopharyngitis
- laryngitis/laryngotracheitis
- Acute bronchitis
- acute otitis media
Show all 9Show fewer
- influenza (confirmed or influenza-like illness)
- pharyngitis/tonsillitis
- acute sinusitis
Who cannot join
- Known immune compromised status, e.g., cystic fibrosis, cancer, organ transplant recipient.
- On immune suppressive therapy for any duration (e.g., steroids, disease modifying antirheumatic agents; cancer chemotherapy, anti-rejection drugs, etc.) in one year prior to presentation
- Known or diagnosed bacterial cause of infection.
- Severe systemic illness requiring referral to the emergency department or hospitalization within 24 hours of presentation
- Known or suspected chronic obstructive pulmonary disease. Asplenic patients (anatomic or functional)
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aim 1: To determine the knowledge, attitude, and practice (KAP) of PHCC physicians regarding appropriate prescription of antibiotics in the outpatient setting.
Hypothesis 1a: PHCC physicians will have adequate theoretical knowledge regarding use of antibiotics for upper respiratory tract infections.
Read more
Hypothesis 1b: Despite adequate theoretical knowledge, fear of complications of untreated infection and patient demand and expectations will drive inappropriate antibiotic prescription for upper respiratory tract infections
Specific Aim 2: To test the effectiveness of a comprehensive multi-component intervention in a cluster randomized trial upon rate of antibiotics prescription for upper respiratory tract infections in individuals aged > 2 years presenting to primary care by PHCC physicians Hypothesis 2: Compared with a single intervention, a comprehensive multi-component intervention package will be associated with a significant reduction in inappropriate antibiotic prescription.
Investigators will conduct this study in the Primary Healthcare Center (PHCC) setting in Qatar. Investigators will identify four large PHCCs from the existing active centers. The study has 2 parts. Part 1 corresponds to specific aim 1 and comprises of a KAP survey which will be carried out in all four PHCCs and will include all physicians. Part 2 corresponds to specific aim 2 and is a cluster randomized clinical trial in which Investigators will randomize the four PHCCs into two groups.
First group (2 PHCCs) will receive training in appropriate documentation of infections and antibiotics prescription and will continue to provide usual care. Second group (2 PHCCs) will receive the comprehensive multi-component intervention, which consists of four elements:
- Option for deferred prescription fulfilment;
- Education of staff regarding appropriate uses of antibiotics,
- algorithm-driven decision support tool,
- Feedback on individual and group performance.
Read the detailed description
As above.
- Conditions
- Drug Use
- Being tested
- comprehensive multi-component interventions
- Keywords
- Prescription rate; Antibiotics;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive multi-component interventionsBehavioural
It is a combination of educational and behavioral interventions. 4 PHCCs will be randomized to 2 groups: 2 PHCCs will receive single intervention and 2 PHCCs will receive all 4 interventions.
| Study group | Role | What they receive |
|---|---|---|
| Control groups with single intervention | Active comparator | The control groups will each receive a single intervention which will be selected at random. Receives: Behavioral: comprehensive multi-component interventions |
| Experimental group with 4 interventions | Experimental | 2 Primary Health Care Centers (PHCCs) will receive the comprehensive multi-component intervention, which consists of four elements:
1. Option for deferred prescription fulfilment.
2. Education of staff regarding appropriate uses of antibiotics.
3. algorithm-driven decision support tool.
4. Feedback on individual and group performance. The training will be repeated at monthly intervals over the 6-month intervention period. Receives: Behavioral: comprehensive multi-component interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of antibiotics courses prescribed for URTIs
For each recorded diagnosis of URTI, investigators will count the number of persons who received an antibiotic prescription. All prescriptions regardless of drug, dose, route of administration and duration will be counted. Only one prescription per 30-day period will be counted to exclude those with ongoing, evolving, or unresolved infection.
Measured: Primary Analysis 11 months; Final analysis 24 months
Proportion of antibiotics prescription dispensed for an inappropriate use
For each antibiotic prescription written for a URTI diagnosis, investigators will determine the appropriateness of antibiotics based on our previously published criteria.
Measured: Total 11 months for primary analysis; Follow-up up to 36 months
Secondary outcomes (2)
Rates of hospitalization in 28 days after the PHCC visit
Number of hospitalizations within 28 days of the index visit
Measured: Total 11 months for primary analysis; Follow-up up to 36 months
Rates of ED visits in 28 days after the PHCC visit
Number of ED visits within 28 days of the index visit
Measured: Total 11 months for primary analysis;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion31 Oct 2024
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Primary Health Care Corporation, Qatar
- Responsible party
- Principal investigator, Adeel Ajwad Butt, Hamad Medical Corporation
- Investigators
- Adeel A. Butt, MBBS, MS, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135376
- Sponsor's protocol ID
- MRC-01-23-076
- Acronym
- E-PAUse
- Status last verified
- Apr 2025
- First submitted
- 9 Nov 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Butt AA, Shams S, Jabeen A, Al-Nuaimi AA, Krishnan JI, Malik AB, Saleem S, Abdulaziz MH, Seyam NI, Aziz K, Kandil D, Thomas AG, Nafady-Hego H, Lone MI, Al Ajmi J, Bhutta ZA, AlSulaiti N, Hussein WES, Semaan S, Al-Abdulla SA, Al-Kuwari MG, Abou-Samra AB. A prospective cluster randomized trial of an interventions bundle to reduce inappropriate antibiotic use for upper respiratory tract infections in the outpatient setting. BMC Infect Dis. 2025 Jul 1;25(1):818. doi: 10.1186/s12879-025-11210-z.
PubMed 40597774
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting
- ClinicalTrials.gov ID
- NCT06135376
- Acronym / sponsor ID
- E-PAUse / MRC-01-23-076
- Conditions
- Drug Use
- Keywords
- Prescription rate; Antibiotics;
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Primary Health Care Corporation, Qatar
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 18 Nov 2023 (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.
Specific Aim 1: To determine the knowledge, attitude, and practice (KAP) of PHCC physicians regarding appropriate prescription of antibiotics in the outpatient setting.
Hypothesis 1a: PHCC physicians will have adequate theoretical knowledge regarding use of antibiotics for upper respiratory tract infections.
Hypothesis 1b: Despite adequate theoretical knowledge, fear of complications of untreated infection and patient demand and expectations will drive inappropriate antibiotic prescription for upper respiratory tract infections
Specific Aim 2: To test the effectiveness of a comprehensive multi-component intervention in a cluster randomized trial upon rate of antibiotics prescription for upper respiratory tract infections in individuals aged > 2 years presenting to primary care by PHCC physicians Hypothesis 2: Compared with a single intervention, a comprehensive multi-component intervention package will be associated with a significant reduction in inappropriate antibiotic prescription.
Investigators will conduct this study in the Primary Healthcare Center (PHCC) setting in Qatar. Investigators will identify four large PHCCs from the existing active centers. The study has 2 parts. Part 1 corresponds to specific aim 1 and comprises of a KAP survey which will be carried out in all four PHCCs and will include all physicians. Part 2 corresponds to specific aim 2 and is a cluster randomized clinical trial in which Investigators will randomize the four PHCCs into two groups.
First group (2 PHCCs) will receive training in appropriate documentation of infections and antibiotics prescription and will continue to provide usual care. Second group (2 PHCCs) will receive the comprehensive multi-component intervention, which consists of four elements:
- Option for deferred prescription fulfilment;
- Education of staff regarding appropriate uses of antibiotics,
- algorithm-driven decision support tool,
- Feedback on individual and group performance.
Detailed description
As above.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control groups with single intervention | Active comparator | Behavioral: comprehensive multi-component interventionsThe control groups will each receive a single intervention which will be selected at random. |
| Experimental group with 4 interventions | Experimental | Behavioral: comprehensive multi-component interventions2 Primary Health Care Centers (PHCCs) will receive the comprehensive multi-component intervention, which consists of four elements: 1. Option for deferred prescription fulfilment. 2. Education of staff regarding appropriate uses of antibiotics. 3. algorithm-driven decision support tool. 4. Feedback on individual and group performance. The training will be repeated at monthly intervals over the 6-month intervention period. |
Who may qualify
- Ages
- 2 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients >2 years old presenting to any of the selected PHCCs (rationale: signs and symptoms of bacterial infection in very young children are more non-specific and empiric antibiotics are often indicated due to serious consequences of unrecognized and untreated bacterial infections)
- Presenting with acute (<1 week of symptoms) upper respiratory tract infection (URTI) like illness including
Key exclusion criteria (5 listed)
- Known immune compromised status, e.g., cystic fibrosis, cancer, organ transplant recipient.
- On immune suppressive therapy for any duration (e.g., steroids, disease modifying antirheumatic agents; cancer chemotherapy, anti-rejection drugs, etc.) in one year prior to presentation
- Known or diagnosed bacterial cause of infection.
- Severe systemic illness requiring referral to the emergency department or hospitalization within 24 hours of presentation
- Known or suspected chronic obstructive pulmonary disease. Asplenic patients (anatomic or functional)
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 |
|---|---|---|
| comprehensive multi-component interventionsIt is a combination of educational and behavioral interventions. 4 PHCCs will be randomized to 2 groups: 2 PHCCs will receive single intervention and 2 PHCCs will receive all 4 interventions. | Behavioural | Control groups with single intervention, Experimental group with 4 interventions |
Primary outcome
Total number of antibiotics courses prescribed for URTIs
Time frame: Primary Analysis 11 months; Final analysis 24 months
For each recorded diagnosis of URTI, investigators will count the number of persons who received an antibiotic prescription. All prescriptions regardless of drug, dose, route of administration and duration will be counted. Only one prescription per 30-day period will be counted to exclude those with ongoing, evolving, or unresolved infection.
Proportion of antibiotics prescription dispensed for an inappropriate use
Time frame: Total 11 months for primary analysis; Follow-up up to 36 months
For each antibiotic prescription written for a URTI diagnosis, investigators will determine the appropriateness of antibiotics based on our previously published criteria.
2 secondary outcomes
Rates of hospitalization in 28 days after the PHCC visit
Time frame: Total 11 months for primary analysis; Follow-up up to 36 months
Rates of ED visits in 28 days after the PHCC visit
Time frame: Total 11 months for primary analysis;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 40597774Butt AA, Shams S, Jabeen A, Al-Nuaimi AA, Krishnan JI, Malik AB, Saleem S, Abdulaziz MH, Seyam NI, Aziz K, Kandil D, Thomas AG, Nafady-Hego H, Lone MI, Al Ajmi J, Bhutta ZA, AlSulaiti N, Hussein WES, Semaan S, Al-Abdulla SA, Al-Kuwari MG, Abou-Samra AB. A prospective cluster randomized trial of an interventions bundle to reduce inappropriate antibiotic use for upper respiratory tract infections in the outpatient setting. BMC Infect Dis. 2025 Jul 1;25(1):818. doi: 10.1186/s12879-025-11210-z.
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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.
Adeel A. Butt, MBBS, MS principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive multi-component interventions in people with Drug Use, run by Hamad Medical Corporation at 1 site in Qatar.
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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 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 Qatar. 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?
This study is still under way. Results are not available in the source record yet.
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 number of antibiotics courses prescribed for URTIs (time frame: Primary Analysis 11 months; Final analysis 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135376, which also lists 1 linked publication.
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 3 Apr 2025.