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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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. * P

Первичные конечные точки

• Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tract [Срок оценки: Through study completion, an average of 6 months]

Вторичные конечные точки (5)

• Disease maintenance [Срок оценки: Within 14 days after enrolment]
• Adverse drug reaction [Срок оценки: Within 14 days after enrolment]
• Disease recurrence within a 14 days period [Срок оценки: Within 14 days after enrolment]
• Disease recurrence within a 14 days period [Срок оценки: Within 14 days after enrolment]
• Worsening of disease within a 14 days period [Срок оценки: Within 14 days after enrolment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Публикации

• Zhang J, Lou SG, Chu J, Zhang L, Wu Q, Xu Y, Dong Y, Hu T, Huo M, Yan P, Shao R, Zhou J, Zhan Z, Zhang M, Ji C, Lin L, Wang J, Zhou S, He M, Deng L, Ke J, Wang J, He J, Chen J, Wang S, Rui Z, Yang T, Huang Y, Zhang Y, Ke L, Chen T, Jiang H, Chen M, Hu Y, Dai H. Impact of pharmaceutical intervention on the use of intravenous antibiotics in patients with bacterial upper respiratory tract infections: PMID 41883827

Идентификаторы

NCT: NCT06620341 · 2024-0469

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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