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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bacterial Infections; Acute Upper Respiratory Tract Infection
• Intervention / Treatment: Behavioral: drug education

• Study Type: Interventional
• Enrollment (Estimated): 11900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haibin Dai, Professor; Phone Number: 86+057187783891; Email: haibindai@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Haibin Dai, Professor; Phone Number: 86+057187783891; Email: haibindai@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist medication education group; Pharmacists give emergency doctors medication education every month about how to use antibiotic infusion reasonably	Behavioral: drug education; Training: Train emergency doctors every month on how to use antibiotic infusion reasonably; The prescription, cancellation, or method of use of antibiotics is decided by doctors.Implementation of intervention cards: When the C-reactive protein (CRP) of patients is exceed 10mg/L, the doctor should determine whether to use antibiotics based on the clinical status of patients.Promotion: Promote reasonably use of intravenous antibiotics through public accounts and posters.Patient education: Distribute educational flyers to patients about how to use antibiotics reasonably.
No Intervention: No pharmacists' education on antibiotics; Following routine clinical practices, with no pharmacists' education on rational use of antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Haibin Dai, Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): November 18, 2024
• Primary Completion (Estimated): April 17, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: pharmacist; Bacterial infection of upper respiratory tract; Infusion rate
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Respiratory Tract Infections; Bacterial Infections
• Other Study ID Numbers: 2024-0469

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No