Clinical trial NCT06620341: A Cluster Randomized Controlled Trial to Compare the Rate of Antibiotic Infusion
Official title: Comparing the Rate of Antibiotic Infusion Among Patients with Acute Upper Respiratory Tract Bacterial Infections in the Emergency Department -- a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Upper Respiratory Tract Infection
Bacterial Infections
Keywords: Bacterial infection of upper respiratory tract
Infusion rate
pharmacist
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 11900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tract
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Disease maintenance
timeFrame: Within 14 days after enrolment
measure: Adverse drug reaction
timeFrame: Within 14 days after enrolment
measure: Disease recurrence within a 14 days period
timeFrame: Within 14 days after enrolment
measure: Disease recurrence within a 14 days period
timeFrame: Within 14 days after enrolment
measure: Worsening of disease within a 14 days period
timeFrame: Within 14 days after enrolment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Haibin Dai, Professor
role: PRINCIPAL_INVESTIGATOR
References: