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

Not Applicable

Recruiting

• Conditions: Antibiotic Prescribing for Acute Respiratory-tract Infections

• Registration Number: NCT06568432
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-23
• Status Verified: 2025-02
• Study Start: 2025-02-15
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19424

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	between the start of intervention and 6 months of follow-up	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 Outcome Measures

Name	Time	Method
The proportion of multiple antibiotic prescriptions in the intervention and control arms.	between the start of intervention and 6 months of follow-up	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	between the start of intervention and 6 months of follow-up	The intravenously injected antibiotic prescription rate (the proportion that contain any antibiotics delivered by intravenous injection)
The proportion containing any Traditional Chinese Medicines.	between the start of intervention and 6 months of follow-up	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	between the start of intervention and 6 months of follow-up	The mean cost of an ARI prescription, based on the cost of any medicines.
The mean cost of a consultation	between the start of intervention and 6 months of follow-up	The mean cost of a consultation, based on all costs including medicines, tests and the consultation.

Trial Locations

Locations (1)

40 Village Clinics; 🇨🇳 Xiantao, Hubei, China