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

Not Applicable

Not yet recruiting

• Conditions: Acute Upper Respiratory Tract Infection; Bacterial Infections
• Interventions: Behavioral: drug education

• Registration Number: NCT06620341
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-29
• Last Update Submitted: 2024-09-29
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Study Start: 2024-11-18
• Primary Completion: 2025-04-17
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 11900

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist medication education group	drug education	Pharmacists give emergency doctors medication education every month about how to use antibiotic infusion reasonably

Primary Outcome Measures

Name	Time	Method
Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tract	Through study completion, an average of 6 months

Secondary Outcome Measures

Name	Time	Method
Disease maintenance	Within 14 days after enrolment	Days of respiratory tract infection symptoms keeps
Adverse drug reaction	Within 14 days after enrolment	Allergic reaction, rash or pruritus
Disease recurrence within a 14 days period	Within 14 days after enrolment	Patients who did not re-attend outpatient clinic or emergency but re-used antibiotic infusion after first visit in emergency
Worsening of disease within a 14 days period	Within 14 days after enrolment	Patients be hospitalized

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China