Actively Recruiting

Phase Not Applicable
All Genders
ID06568432

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

Led by Huazhong University of Science and Technology · Updated on 2025-03-05

19424

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Huazhong University of Science and Technology

Lead Sponsor

U

University of Toronto

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of C-reactive Protein (CRP) and Serum Amyloid A (SAA) point-of-care testing (POCT) on antibiotic prescribing for patients with acute respiratory-tract infections (ARI) at primary care facilities in rural China. This practical, cluster-randomized controlled trial aims to see if using CRP and SAA tests helps guide antibiotic use during initial patient visits. The study includes two groups: an intervention group where 20 village clinics will receive CRP and SAA POCT devices along with additional physician training and patient education materials, and a control group that will continue with usual care without these interventions. Physician training involves centralized sessions, manuals, and reminders to support the use of POCT. The control group will not receive any additional interventions. Participants diagnosed with ARIs and presenting with at least one respiratory symptom will be followed for six months. Researchers will measure how often antibiotics are prescribed during the initial visit and monitor other outcomes such as multiple antibiotic prescriptions, intravenous antibiotic use, use of Traditional Chinese Medicines, and costs of prescriptions and consultations. The trial includes careful documentation and comparison of these outcomes between the two groups to understand the impact of CRP and SAA POCT on antibiotic prescribing practices.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of all ages diagnosed by a village doctor with acute respiratory-tract infections (including upper and lower respiratory infections)
  • Patients presenting with at least one acute respiratory symptom such as cough, rhinitis (sneezing, nasal congestion, or runny nose), sore throat, shortness of breath, wheezing, or abnormal lung sounds
  • Village clinics with annual outpatient volume over 2000 and an average of 10 or more patients per week with acute respiratory infections
  • Clinics with licensed prescribers
Not Eligible

You will not qualify if you...

  • Patients with non-respiratory diseases
  • Patients with severe clinical symptoms that require referral to a higher-level healthcare institution

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 6 months

Participants diagnosed with acute respiratory-tract infections receive point-of-care testing for C-reactive Protein and Serum Amyloid A (CRP & SAA POCT) at village clinics in the intervention group, along with physician training and patient education to guide antibiotic prescribing.

1 visit at initial diagnosis

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored for antibiotic prescribing patterns and outcomes during follow-up after their initial visit.

Follow-up assessments as part of routine care

Trial Site Locations

Total: 1 location

1

40 Village Clinics

Xiantao, Hubei, China, 433000

Actively Recruiting

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Research Team

X

Xiaoxv Yin, PhD

M

Minzhi Xu, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

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.

Minzhi Xu, Zhitong Zhang, Erjia Ge...

https://pubmed.ncbi.nlm.nih.gov/40920832