E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting

NCT ID: NCT06135376

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-04-30

Brief 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.

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:

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.

Detailed Description

As above.

Conditions

Drug Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control groups with single intervention

The control groups will each receive a single intervention which will be selected at random.

Group Type: ACTIVE_COMPARATOR

comprehensive multi-component interventions

Intervention Type: BEHAVIORAL

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.

Experimental group with 4 interventions

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.

Group Type: EXPERIMENTAL

comprehensive multi-component interventions

Intervention Type: BEHAVIORAL

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.

Interventions

comprehensive multi-component interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• influenza (confirmed or influenza-like illness)
• pharyngitis/tonsillitis
• acute sinusitis

Exclusion Criteria

• 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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Primary Health Care Corporation, Qatar

OTHER_GOV

Sponsor Role: collaborator

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Adeel Ajwad Butt

Senior Consultant in Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adeel A. Butt, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

PHCC

Doha, , Qatar

Countries

Qatar

References

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.

Reference Type: DERIVED

PMID: 40597774 (View on PubMed)

Other Identifiers

MRC-01-23-076

Identifier Type: -

Identifier Source: org_study_id