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Acute Upper Respiratory Tract InfectionNCT06620341

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

A study testing drug education in people with Acute Upper Respiratory Tract Infection and Bacterial Infections, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
drug education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11,900 participants
Where
1 siteChina
Study dates
18 Nov 2024to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Haibin Dai, Professor contact

86+057187783891

haibindai@zju.edu.cn

China1 site

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Haibin Dai, Professor, 86+057187783891, haibindai@zju.edu.cn

Other trials in China

About this study

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

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.

Being tested
drug education
Keywords
Bacterial infection of upper respiratory tract, Infusion rate, pharmacist
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • drug educationBehavioural

    • 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.
Study groups in NCT06620341
Study groupRoleWhat they receive
Pharmacist medication education groupExperimentalPharmacists give emergency doctors medication education every month about how to use antibiotic infusion reasonably
Receives: Behavioral: drug education
No pharmacists' education on antibioticsNo interventionFollowing routine clinical practices, with no pharmacists' education on rational use of antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Through study completion, an average of 6 months

Secondary outcomes (5)

  1. Disease maintenance

    Days of respiratory tract infection symptoms keeps

    Measured: Within 14 days after enrolment

  2. Adverse drug reaction

    Allergic reaction, rash or pruritus

    Measured: Within 14 days after enrolment

  3. Disease recurrence within a 14 days period

    Patients re-attend outpatient clinic or emergency department of the hospital for treatment

    Measured: Within 14 days after enrolment

  4. 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

    Measured: Within 14 days after enrolment

  5. Worsening of disease within a 14 days period

    Patients be hospitalized

    Measured: Within 14 days after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start18 Nov 2024 (estimated)
  3. Primary completion17 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
11,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06620341
Sponsor's protocol ID
2024-0469
Status last verified
Sep 2024
First submitted
27 Sep 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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: protocol for a cluster-randomized controlled trial. Front Public Health. 2026 Mar 10;14:1742217. doi: 10.3389/fpubh.2026.1742217. eCollection 2026.

    PubMed 41883827

Questions about this trial

What is this clinical trial studying?

A study testing drug education in people with Acute Upper Respiratory Tract Infection and Bacterial Infections, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haibin Dai, Professor (86+057187783891, haibindai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infusion rate of antibacterial drugs in patients with bacterial infection of upper respiratory tract (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06620341, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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