A global low- and middle-income country primary care antimicrobial stewardship trial using the WHO AWaRe system – the AWaRe 1 Trial

The AWaRe1 pragmatic cluster-randomised trial, economic and process evaluation of antibiotic stewardship in primary healthcare of acute respiratory infections in low- and middle- income countries using the WHO AWaRe system

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10957189

Enrollment

8640

Registered

2024-08-14

Start date

2025-03-15

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optimising antibiotic use in patients presenting to primary healthcare facilities with acute respiratory tract infection symptoms Infections and Infestations

Interventions

This will be a pragmatic parallel arm multi-country cluster randomised superiority trial. The clusters will be primary healthcare centres and eligible patients attending them. Clusters will be randomi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female adult or child aged over 1 year attending a primary healthcare facility with symptoms of acute respiratory illness: 1. Cough with or without fever 2. Chest symptoms (sputum, wheezing) 3. Ear, nose, sinus, or throat symptoms: - Rhinitis (nasal discharge or blocked nose) - Sore throat - Ear pain - Facial pain

Exclusion criteria

Exclusion criteria: 1. Respiratory symptoms have persisted for more than 14 days (that is, symptoms not acute) 2. Undifferentiated fever (without any respiratory symptoms) 3. Referred from another primary healthcare facility for management of the same problem

Design outcomes

Primary

Measure	Time frame
Receipt of, or prescription for, any antibiotic during facility visit (measured at exit interview six months after intervention began)	—

Secondary

Measure	Time frame
Measured at exit interviews at 6 and 12 months, and telephone interviews 14 and 28 days after the 6-month exit interview: 1. Receipt of, or prescription for, antibiotics 2. Category of antibiotics 3. Completion of antibiotic treatment 4. Receipt of any additional antibiotic after the facility visit 5. Respiratory symptoms including severity and days until recovery 6. Health-related quality of life 7. Healthcare utilisation and healthcare expenditure 8. Safety indicators 9. Cost and cost-effectiveness of the intervention 10. Process of intervention delivery and its effects	—

Measure

Time frame

Measured at exit interviews at 6 and 12 months, and telephone interviews 14 and 28 days after the 6-month exit interview: 1. Receipt of, or prescription for, antibiotics 2. Category of antibiotics 3. Completion of antibiotic treatment 4. Receipt of any additional antibiotic after the facility visit 5. Respiratory symptoms including severity and days until recovery 6. Health-related quality of life 7. Healthcare utilisation and healthcare expenditure 8. Safety indicators 9. Cost and cost-effectiveness of the intervention 10. Process of intervention delivery and its effects

—

Countries

Bangladesh, Indonesia, Nigeria, Viet Nam

Contacts

Public ContactJennifer Martin

jmartin@citystgeorges.ac.uk+44 20 8725 5382

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026