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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHuazhong University of Science and Technology

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • CRP+SAA POCT

    Device

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

Treatment groups

19,424 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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).

Time frame
between the start of intervention and 6 months of follow-up
2

The intravenously injected antibiotic prescription rate

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

Time frame
between the start of intervention and 6 months of follow-up
3

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.

Time frame
between the start of intervention and 6 months of follow-up
4

The mean cost of an ARI prescription

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

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

Other outcomes

Sponsors and contacts

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