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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06620341
Enrollment
11900
Registered
2024-10-01
Start date
2024-11-18
Completion date
2025-04-30
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Upper Respiratory Tract Infection, Bacterial Infections

Keywords

Bacterial infection of upper respiratory tract, Infusion rate, pharmacist

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.

Interventions

BEHAVIORALdrug 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Because of the nature of the intervention, masking of doctors and participants was not possible, but telephone follow-up staff and data analysts were masked to allocation group until after the definitive analysis was done.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tractThrough study completion, an average of 6 months

Secondary

MeasureTime frameDescription
Disease maintenanceWithin 14 days after enrolmentDays of respiratory tract infection symptoms keeps
Adverse drug reactionWithin 14 days after enrolmentAllergic reaction, rash or pruritus
Disease recurrence within a 14 days periodWithin 14 days after enrolmentPatients re-attend outpatient clinic or emergency department of the hospital for treatment
Worsening of disease within a 14 days periodWithin 14 days after enrolmentPatients be hospitalized

Countries

China

Contacts

Primary ContactHaibin Dai, Professor
haibindai@zju.edu.cn86+057187783891

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026