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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

19424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting

NCT01918579

Acute Respiratory Infections

COMPLETED NA

Point of Care Polymerase Chain Reaction (PCR) Diagnostics of Respiratory Tract Infections in General Practice

NCT06120153

Respiratory Tract Infections

ACTIVE_NOT_RECRUITING NA

PCOT for Outpatients With Acute Respiratory Tract Infection at Risk of Severe Disease in Primary Healthcare

NCT07159230

Acute Respiratory Tract Infection

NOT_YET_RECRUITING NA

Diagnostic Accuracy of Infection Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia

NCT04652167

Pneumonia, Bacterial

COMPLETED

A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections

NCT07109310

Sepsis Acute Respiratory Distress Syndrome Community Acquired Pneumonia +1 more

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotic Prescribing for Acute Respiratory-tract Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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)

Group Type EXPERIMENTAL

CRP+SAA POCT

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CRP+SAA POCT

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No