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NCT Number: NCT06568432

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

40 Village Clinics

Xiantao, Hubei, 433000, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRP+SAA POCT

Device

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

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.

    Time frame: between the start of intervention and 6 months of follow-up

    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.

Secondary outcomes

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

    Time frame: between the start of intervention and 6 months of follow-up

    The proportion of multiple antibiotic prescriptions in the intervention and control arms (specifically, the proportion of ARI prescriptions that include two or more antibiotics).

  2. The intravenously injected antibiotic prescription rate

    Time frame: between the start of intervention and 6 months of follow-up

    The intravenously injected antibiotic prescription rate (the proportion that contain any antibiotics delivered by intravenous injection)

  3. The proportion containing any Traditional Chinese Medicines.

    Time frame: between the start of intervention and 6 months of follow-up

    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.

  4. The mean cost of an ARI prescription

    Time frame: between the start of intervention and 6 months of follow-up

    The mean cost of an ARI prescription, based on the cost of any medicines.

  5. The mean cost of a consultation

    Time frame: between the start of intervention and 6 months of follow-up

    The mean cost of a consultation, based on all costs including medicines, tests and the consultation.

Study contacts

Contact information is provided by the study sponsor or research team.

Minzhi Xu, PhD

CONTACT

[email protected]

+86 18737357795

Xiaoxv Yin, PhD

CONTACT

[email protected]

+86 13871187781

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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