Antibiotic Prescribing for Acute Respiratory-tract InfectionsNCT06568432
Effect of CRP and SAA Point-of-care Testing on Antibiotic Prescribing for Acute Respiratory-tract Infections
A study testing CRP+SAA POCT in people with Antibiotic Prescribing for Acute Respiratory-tract Infections, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Prescribing for Acute Respiratory-tract Infections
- What is being tested?
- CRP+SAA POCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35,108 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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) 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.
- Being tested
- CRP+SAA POCT
- Keywords
- point-of-care testing, acute respiratory-tract infections, primary care facilities, Antibiotic prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP+SAA POCTDevice
CRP+SAA POCT will be provided in 20 village clinics in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: CRP+SAA POCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The proportion of multiple antibiotic prescriptions in the intervention and control arms (specifically, the proportion of ARI prescriptions that include two or more antibiotics).
Measured: between the start of intervention and 6 months of follow-up
The intravenously injected antibiotic prescription rate
The intravenously injected antibiotic prescription rate (the proportion that contain any antibiotics delivered by intravenous injection)
Measured: between the start of intervention and 6 months of follow-up
The proportion containing any Traditional Chinese Medicines.
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.
Measured: between the start of intervention and 6 months of follow-up
The mean cost of an ARI prescription
The mean cost of an ARI prescription, based on the cost of any medicines.
Measured: between the start of intervention and 6 months of follow-up
The mean cost of a consultation
The mean cost of a consultation, based on all costs including medicines, tests and the consultation.
Measured: between the start of intervention and 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start15 Feb 2025
- Primary completion15 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Prescribing for Acute Respiratory-tract InfectionsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Xiaoxv Yin, PhD, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568432
- Sponsor's protocol ID
- HuazhongU20240822
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. eCollection 2026 Jun.
PubMed 42239972Xu 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.
PubMed 40920832
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06568432
- Acronym / sponsor ID
- HuazhongU20240822
- Keywords
- point-of-care testing, acute respiratory-tract infections, primary care facilities, Antibiotic prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35,108 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will not have any intervention, as the control (usual care) |
| Intervention group | Experimental | Device: CRP+SAA POCTCRP\&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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRP+SAA POCTCRP+SAA POCT will be provided in 20 village clinics in the intervention group | Device | Intervention group |
Primary outcome
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.
5 secondary outcomes
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 intravenously injected antibiotic prescription rate
Time frame: between the start of intervention and 6 months of follow-up
The proportion containing any Traditional Chinese Medicines.
Time frame: between the start of intervention and 6 months of follow-up
The mean cost of an ARI prescription
Time frame: between the start of intervention and 6 months of follow-up
The mean cost of a consultation
Time frame: between the start of intervention and 6 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 42239972Xu 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. eCollection 2026 Jun.
- Derived from this study: PubMed 40920832Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP+SAA POCT in people with Antibiotic Prescribing for Acute Respiratory-tract Infections, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06568432, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.