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A Cluster Randomized Controlled Trial to Compare the Rate of Antibiotic Infusion

Zhejiang University logo

Zhejiang University

Status

Not yet enrolling

Conditions

Acute Upper Respiratory Tract Infection
Bacterial Infections

Treatments

Behavioral: drug education

Study type

Interventional

Funder types

Other

Identifiers

NCT06620341
2024-0469

Details and patient eligibility

About

Acute upper respiratory tract infection, commonly known as upper respiratory infection, is an acute inflammation primarily affecting the nose, pharynx, or larynx caused by various viruses and/or bacteria. Viruses are more common, accounting for 70% to 80% of cases, while bacterial infections account for 20% to 30%. For a long time, the high rate of intravenous infusion use has been a prominent issue in clinical diagnosis and treatment in China. The irrational and excessive use of antimicrobials in emergency patients with upper respiratory tract bacterial infections has also become increasingly apparent, imposing unnecessary financial burdens and risks of drug side effects on patients. Therefore, reducing the rate of intravenous antimicrobial administration in emergency patients with upper respiratory tract bacterial infections has become an urgent problem to be solved. By implementing measures such as health education by clinical pharmacists and enhancing the awareness of rational antimicrobial use in doctors, it is expected to lower the rate of intravenous antimicrobial administration, reduce the occurrence of drug resistance, improve treatment convenience for patients, and lower treatment costs while ensuring therapeutic efficacy.

The purpose of this study was to investigate whether clinical pharmacists can reduce the intravenous infusion rate of antimicrobials in emergency patients with upper respiratory tract bacterial infections through medication education for emergency medical staff and to observe whether this intervention will affect the prognosis and medication safety of these patients.

Enrollment

11,900 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with upper respiratory tract infections seeking emergency medical attention;

    • Patients with laboratory tests indicating White Blood Cell (WBC) >10×10^9/L or White Blood Cell (CRP) ≥ 10.0mg/L, requiring the use of antimicrobial agents;

      • Patients aged ≥ 18 years; ④ Patients with at least one of the following local signs and symptoms: (1) fever, (2) cough, (3) rhinitis (sneezing, nasal congestion, or rhinorrhea), (4) pharyngitis (sore throat), (5) shortness of breath, (6) wheezing, (7) chest pain, (8) abnormal auscultation findings.

Exclusion criteria

  • Patients with other infections in addition to upper respiratory tract infections; ② Patients who require hospitalization or treatment in a higher-level medical institution as assessed by medical professionals;

    • Patients who cannot take oral medications or have severe gastrointestinal dysfunction; ④ Special patients, including those with neutropenia, bone marrow suppression, during radiochemotherapy, undergoing immunosuppressive therapy, human immunodeficiency virus (HIV)-positive patients, patients with congenital immune deficiency, pregnant patients, and patients with mental illnesses.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

11,900 participants in 2 patient groups

Pharmacist medication education group
Experimental group
Description:
Pharmacists give emergency doctors medication education every month about how to use antibiotic infusion reasonably
Treatment:
Behavioral: drug education
No pharmacists' education on antibiotics
No Intervention group
Description:
Following routine clinical practices, with no pharmacists' education on rational use of antibiotics

Trial contacts and locations

1

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Central trial contact

Haibin Dai, Professor

Data sourced from clinicaltrials.gov

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