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Clinical Trials/NCT06620341
NCT06620341
Not Yet Recruiting
N/A

Comparing the Rate of Antibiotic Infusion Among Patients with Acute Upper Respiratory Tract Bacterial Infections in the Emergency Department -- a Cluster Randomized Controlled Trial

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country11,900 target enrollmentNovember 18, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Upper Respiratory Tract Infection
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
11900
Locations
1
Primary Endpoint
Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tract
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2024
End Date
April 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tract

Time Frame: Through study completion, an average of 6 months

Secondary Outcomes

  • Disease maintenance(Within 14 days after enrolment)
  • Adverse drug reaction(Within 14 days after enrolment)
  • Disease recurrence within a 14 days period(Within 14 days after enrolment)
  • Worsening of disease within a 14 days period(Within 14 days after enrolment)

Study Sites (1)

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