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

NCT06568432 | Recruiting DMC

• 1 other identifier: HuazhongU20240822
• Study Type: interventional
• Target: 19,424
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Prescribing for Acute Respiratory-tract Infections

Keywords

point-of-care testing; acute respiratory-tract infections; primary care facilities; Antibiotic prescription

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The proportion of multiple antibiotic prescriptions in the intervention and control arms.

  between the start of intervention and 6 months of follow-up

• The intravenously injected antibiotic prescription rate

  between the start of intervention and 6 months of follow-up

• The proportion containing any Traditional Chinese Medicines.

  between the start of intervention and 6 months of follow-up

• The mean cost of an ARI prescription

  between the start of intervention and 6 months of follow-up

• The mean cost of a consultation

  between the start of intervention and 6 months of follow-up

Study Arms (2)

Control group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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

Interventions

CRP+SAA POCT DEVICE

CRP+SAA POCT will be provided in 20 village clinics in the intervention group

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• University of Toronto: collaborator

Study Sites (1)

40 Village Clinics

Xiantao, Hubei, 433000, China

RECRUITING

Related Publications (1)

• Xu M, Zhang Z, Ge E, Xie CX, Bai X, Zhu Y, Kuang G, Li J, Wang J, Wei X, Yin X. 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. PLoS One. 2025 Sep 8;20(9):e0331646. doi: 10.1371/journal.pone.0331646. eCollection 2025.

  PMID: 40920832 DERIVED

Central Study Contacts

Xiaoxv Yin, PhD

CONTACT

+86 13871187781; yxx@hust.edu.cn

Minzhi Xu, PhD

CONTACT

+86 18737357795; 619581384@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Social Medicne and Health Management Department

Model Details: In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: February 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)