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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: between the start of intervention and 6 months of follow-up]

Вторичные конечные точки (5)

• The proportion of multiple antibiotic prescriptions in the intervention and control arms. [Срок оценки: between the start of intervention and 6 months of follow-up]
• The intravenously injected antibiotic prescription rate [Срок оценки: between the start of intervention and 6 months of follow-up]
• The proportion containing any Traditional Chinese Medicines. [Срок оценки: between the start of intervention and 6 months of follow-up]
• The mean cost of an ARI prescription [Срок оценки: between the start of intervention and 6 months of follow-up]
• The mean cost of a consultation [Срок оценки: between the start of intervention and 6 months of follow-up]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• 40 Village Clinics — Xiantao

Публикации

• Xu M, Wang J, Zhang Z, Ge E, Zhu Y, Li J, Gong Y, Lu Z, Wei X, Yin X. Effect of a comprehensive package based on combined 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 cluster randomised controlled trial. Lancet Reg Health West Pac. 2026 May 25;71:101888. doi: 10.1016/j.lanwpc.2026.101888 PMID 42239972
• 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

Идентификаторы

NCT: NCT06568432 · HuazhongU20240822

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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