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

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.

Study Overview

• Status: Recruiting
• Conditions: Antibiotic Prescribing for Acute Respiratory-tract Infections
• Intervention / Treatment: Device: CRP+SAA POCT

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 Type: Interventional
• Enrollment (Estimated): 19424
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoxv Yin, PhD; Phone Number: +86 13871187781; Email: yxx@hust.edu.cn
• Study Contact Backup: Name: Minzhi Xu, PhD; Phone Number: +86 18737357795; Email: 619581384@qq.com

Study Locations

• China
  • Hubei
    • Xiantao, Hubei, China, 433000
      • Recruiting
      • 40 Village Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group will not have any intervention, as the control (usual care)
Experimental: Intervention group; 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)	Device: CRP+SAA POCT; CRP+SAA POCT will be provided in 20 village clinics in the intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	between the start of intervention and 6 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	between the start of intervention and 6 months of follow-up
The intravenously injected antibiotic prescription rate	The intravenously injected antibiotic prescription rate (the proportion that contain any antibiotics delivered by intravenous injection)	between the start of intervention and 6 months of follow-up
The mean cost of an ARI prescription	The mean cost of an ARI prescription, based on the cost of any medicines.	between the start of intervention and 6 months of follow-up
The mean cost of a consultation	The mean cost of a consultation, based on all costs including medicines, tests and the consultation.	between the start of intervention and 6 months of follow-up
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.	between the start of intervention and 6 months of follow-up

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): August 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Antibiotic prescription; point-of-care testing; acute respiratory-tract infections; primary care facilities
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: HuazhongU20240822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No