NCT04358289 Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam
| NCT ID | NCT04358289 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oxford University Clinical Research Unit, Vietnam |
| Condition | Antibiotic Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,315 participants |
| Start Date | 2020-02-27 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,315 participants in total. It began in 2020-02-27 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to develop community-based interventions targetting inappropriate antibiotic dispensing and use behaviours in rural Vietnam and has 3 research components. Community and primary healthcare interventions: The investigators will conduct a four-armed cluster randomised controlled trial. The first arm will be a control arm with no interventions. The second intervention arm will have a basic antimicrobial stewardship intervention, involving working with the Ministry of Health, Medical Services Administration to revise guidelines for antibiotic prescribing for acute respiratory infections (ARI) in primary care, and then training primary healthcare doctors in their use. The third intervention arm will have basic antimicrobial stewardship guidelines and training for primary healthcare doctors, plus educational materials for the community, disseminated through posters, leaflets and local media channels. The fourth intervention arm will use a participatory action research approach to engage primary healthcare doctors and communities, in addition to the basic guidelines and training materials. The participatory action research approach will train local facilitators to lead community and health-worker groups through a cycle of problem identification, strategy development, implementation and review, focusing on inappropriate human and small-scale agricultural use of antibiotics. Hospital interventions: The investigators will work with Provincial and District Hospitals serving these communities to implement quality improvement cycles for antibiotic stewardship, also using a participatory action research approach. This will also follow a cycle of a cycle of problem identification, strategy development, implementation and review.
Eligibility Criteria
For communities: Inclusion criteria: * Commune officials consent to take part; * Have a commune population larger than 3000 individuals; * Have active Women's Union and Farmers' Union groups with a paid commune-level representative; * Commune health centre has a doctor; * Commune health centre has electronic database. Exclusion criteria: * Urban areas with a low proportion of farmers or low utilisation of CHCs for primary healthcare. For study participants: Inclusion criteria: * Participant is willing and able to give informed consent for participation in the study; * Community members normally resident in the study commune (living in the study commune and resident for at least three months); Exclusion criteria: * No one will be actively excluded from participating in this population-based study. For Commune Health Centers: Inclusion criteria: * Serve a commune population larger than 3000 individuals; * Have an average caseload of at least 10 consultations per facility per week for ARI verified by checking the database system of the provincial centre for disease control and prevention (CDC) where the implementation study is being conducted; * Health centre doctor is normally employed at the centre and has been there for at least three months. Exclusion criteria: * Low antibiotic prescription rate for ARI of below 40%. For Patient records: Inclusion criteria: * All patients' anonymised records. Exclusion criteria: * Don't have national health insurance/not recorded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04358289 clinical trial?
This trial is open to participants of all sexes, studying Antibiotic Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04358289 currently recruiting?
Yes, NCT04358289 is actively recruiting participants. Contact the research team at slewycka@oucru.org for enrollment information.
Where is the NCT04358289 trial being conducted?
This trial is being conducted at Nam Định, Vietnam.
Who is sponsoring the NCT04358289 clinical trial?
NCT04358289 is sponsored by Oxford University Clinical Research Unit, Vietnam. The trial plans to enroll 3,315 participants.