Impact of point-of-care testing on antibiotic use for respiratory infections
Effect of C-reactive Protein and Serum Amyloid a Point-of-care Testing on Antibiotic Prescribing for Acute Respiratory-tract Infections At Village Clinics in China: a Study Protocol for a Cluster Randomised Controlled Trial
This study is testing if using quick tests for certain markers can help doctors in rural China prescribe fewer antibiotics for patients with respiratory infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 19424 (estimated) |
| Sex | All |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Xiantao, Hubei) |
| Trial ID | NCT06568432 on ClinicalTrials.gov |
What this trial studies
This study evaluates how point-of-care testing for CRP and SAA affects antibiotic prescribing practices for patients with acute respiratory-tract infections in rural China. It is a cluster-randomized controlled trial involving 20 village clinics that will implement the testing and additional physician training, while a control group will continue with usual care. The primary outcome is the rate of antibiotic prescriptions among patients diagnosed with ARIs during their initial visit. The study aims to improve antibiotic stewardship in primary care settings.
Who should consider this trial
Good fit: Ideal candidates include patients of all ages diagnosed with acute respiratory infections by village doctors.
Not a fit: Patients with non-respiratory diseases or severe symptoms requiring referral to higher-level care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more appropriate antibiotic prescribing, reducing unnecessary use and combating antibiotic resistance.
How similar studies have performed: Other studies have shown that point-of-care testing can effectively reduce unnecessary antibiotic prescriptions, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility criteria for clusters Village clinics with an annual outpatient volume exceeding 2000, an average of 10 or more patients per week presenting with ARIs, and licensed prescribers are considered eligible for selection for the intervention. Annual outpatient prescriptions and average weekly visits for ARIs will be verified by obtaining prescription data from all village clinics for the previous year, as documented in the information section of the local health board. Eligibility criteria for participants The target population of this study included (1) patients of all ages diagnosed by a village doctor with ARIs (including upper and lower respiratory infections); and (2) patients who present with ≥1 acute respiratory symptoms (including cough, rhinitis (sneezing, nasal congestion or runny nose), sore throat, shortness of breath, wheezing or abnormal auscultation). Patients with non-respiratory diseases or those with severe clinical symptoms requiring referral to a higher-level institution are excluded from the target population.
Where this trial is running
Xiantao, Hubei
- 40 Village Clinics — Xiantao, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xiaoxv Yin, PhD
- Email: yxx@hust.edu.cn
- Phone: +86 13871187781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.