About this trial
The study was a practical, cluster-randomized controlled trial to evaluate the impact of CRP and SAA point-of-care testing (CRP\&SAA POCT) on antibiotic prescribing in patients with acute respiratory-tract infections (ARI) at primary care facilities in rural China.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
CRP+SAA POCT
DeviceCRP+SAA POCT will be provided in 20 village clinics in the intervention group
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome is the proportion of patients who are diagnosed with ARIs and prescribed antibiotics during their initial visit (defined as no prescription record at the current institution within the preceding 14 days) in both study arms.
This outcome serves as the primary indicator, reflecting the overall impact of a comprehensive intervention based on CRP\&SAA POCT in guiding antibiotic use for patients with ARIs. Since most self-limiting ARIs are caused by viral infections that do not require antibiotic treatment, the decline in antibiotic prescribing rates suggests that village doctors are prescribing antibiotics more judiciously. The selection of this outcome is both feasible and reliable within the context of village clinics in China. This is due to the transition of prescriptions from traditional paper documents to electronic storage, which allows for the proper preservation of prescription records, thereby ensuring data integrity and traceability.
Secondary outcomes
The proportion of multiple antibiotic prescriptions in the intervention and control arms.
The proportion of multiple antibiotic prescriptions in the intervention and control arms (specifically, the proportion of ARI prescriptions that include two or more antibiotics).
The intravenously injected antibiotic prescription rate
The intravenously injected antibiotic prescription rate (the proportion that contain any antibiotics delivered by intravenous injection)
The proportion containing any Traditional Chinese Medicines.
The investigators included the proportion of participants using any form of Traditional Chinese Medicines as a secondary outcome. In the investigators' previous trials, the investigators observed an increase in the use of Traditional Chinese Medicines, possibly as an alternative to antibiotics.
The mean cost of an ARI prescription
The mean cost of an ARI prescription, based on the cost of any medicines.
Sponsors and contacts
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Huazhong University of Science and Technology
Lead sponsor
University of Toronto
Collaborator