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

NCT06620341 | Not Yet Recruiting DMC

• 1 other identifier: 2024-0469
• Study Type: interventional
• Target: 11,900
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Upper Respiratory Tract Infection; Bacterial Infections

Keywords

Bacterial infection of upper respiratory tract; Infusion rate; pharmacist

Outcome Measures

Primary Outcomes (1)

• Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tract

  Through study completion, an average of 6 months

Secondary Outcomes (5)

• Disease maintenance

  Within 14 days after enrolment

• Adverse drug reaction

  Within 14 days after enrolment

• Disease recurrence within a 14 days period

  Within 14 days after enrolment

• Disease recurrence within a 14 days period

  Within 14 days after enrolment

• Worsening of disease within a 14 days period

  Within 14 days after enrolment

Study Arms (2)

Pharmacist medication education group

EXPERIMENTAL

Pharmacists give emergency doctors medication education every month about how to use antibiotic infusion reasonably

Behavioral: drug education

No pharmacists' education on antibiotics

NO INTERVENTION

Following routine clinical practices, with no pharmacists' education on rational use of antibiotics

Interventions

drug education BEHAVIORAL

* 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.

Pharmacist medication education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Haibin Dai, Professor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haibin Dai, Professor

CONTACT

86+057187783891; haibindai@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: November 18, 2024
• Primary Completion: April 17, 2025
• Study Completion: April 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (1)