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) aged 1 to 75 years 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) aged 1 to 75 years 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 of this study was antibiotic prescribing rates (defined as the proportion of outpatients aged 1 to 75 years who were diagnosed with ARI at the first visit to the village clinic and were prescribed at least one antibiotic) among all ARI patients in the intervention and control arms between the start of the intervention and 6 months of follow-up.

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-23
• Status Verified: 2024-12
• Study Start: 2024-12-10
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of patients aged 1 to 75 years who are diagnosed with ARIs and are prescribed initial antibiotics in the two study arms	between the start of intervention and 6 months of follow-up	Antibiotic prescription rates for all ARI patients in the intervention and control arms between the start of intervention and 6 months of follow-up

Secondary Outcome Measures

Name	Time	Method
The proportion of newly diagnosed ARI patients prescribed antibiotics, categorized by age groups (1-15 /16-65 / 65-75 years), sex, type of infection (upper respiratory tract infection/lower respiratory tract infection), and season	between the start of intervention and 6 months of follow-up	Proportion of newly diagnosed ARI patients prescribed antibiotics stratified by age (1-15 years \\16-65 years \\65-75 years), sex, type of infection (upper respiratory tract infection/lower respiratory tract infection), and season.
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	Proportion of ARI prescriptions containing two or more antibiotics
The proportion of ARI patients in both the intervention and control arms who visited the village clinic again for ARI treatment within 14 days	between the start of intervention and 6 months of follow-up	The proportion of ARI patients in both the intervention and control arms who visited the village clinic again for ARI treatment within 14 days
The proportion of ARI patients in both the intervention and control arms who are hospitalized within 14 days following their initial ARI visit, excluding those who are referred during the initial visit.	between the start of intervention and 6 months of follow-up	The proportion of ARI patients in both the intervention and control arms who are hospitalized within 14 days following their initial ARI visit, excluding those who are referred during the initial visit.
The proportion of patients in both the intervention and control arms who were prescribed antibiotics for ARIs at the time of initial diagnosis during the same period in the year prior to the intervention	the same period one year before the intervention began	The proportion of patients in both the intervention and control arms who were prescribed antibiotics for ARIs at the time of initial diagnosis during the same period in the year prior to the intervention.
The mean cost of ARI prescriptions	between the start of intervention and 6 months of follow-up	Mean cost of ARI prescriptions in the intervention and control arms

Trial Locations

Locations (1)

40 Village Clinics; 🇨🇳 Xiantao, Hubei, China