Effect of CRP and SAA Point-of-care Testing on Antibiotic Prescribing for Acute Respiratory-tract Infections

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Antibiotic Prescribing for Acute Respiratory-tract Infections

Treatments: Device: CRP+SAA POCT

Study type: Interventional

Funder types: Other

Identifiers

NCT06568432

HuazhongU20240822

Details and patient eligibility

About

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.

Full description

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. The study includes two arms, in which CRP&SAA POCT will be provided in 20 village clinics in the intervention arm. Additional physician training on the use of CRP&SAA POCT (including centralized training, distribution of physician training manuals, and desk reminders) and patient education sheets (to help patients understand the help of CRP&SAA POCT in guiding their care) will also be provided；The control arm will not receive any intervention and will serve as the control (usual care). 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.

Enrollment: 19,424 estimated patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

19,424 participants in 2 patient groups

Control group

No Intervention group

Description:

The control group will not have any intervention, as the control (usual care)

Intervention group

Experimental group

Description:

CRP\&SAA POCT will be provided in 20 village clinics in the intervention group and additional physician training on the use of CRP\&SAA POCT will be provided (including centralized and unified training, distribution of physician training manuals and desk reminders)

Treatment:

Device: CRP+SAA POCT