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Recruiting NCT06114706

Best Assessment of Sore Throat and Antibiotic Prescribing

No phase Interventional Pharyngitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physicians assess patients, Nurses assess patients, Pharmacists assess patients.
Who it may be relevant to
Registry conditions: Pharyngitis. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This project aims to investigate if an organisational change of patient flow away from medical practitioners can reduce unnecessary antibiotic prescribing in patients attending with a sore throat as the main complaint.

Detailed description

Today patients appear either at a PHC centre or at the Pharmacy. The Pharmacy may provide advice on analgesic or refer the patient to a PHC centre. At the PHC centre, the patient may first appear to the medical practitioner or a nurse pending on local routines. The current Swedish guideline recommends no antibiotics and no testing for patients with 0-2 Centor criteria. For patients with 3-4 Centor criteria the guideline recommends testing and only consider antibiotics if GAS is present.

COVID-19 has gradually transformed from expressing itself as a severe lower respiratory tract infection to be more of an upper respiratory tract infection. Furthermore, COVID-19 is likely to transform from a pandemic to an endemic state with a low continuous incidence. Hence, in response to COVID-19 it seems crucial to identify to what extent the common sore throat is caused by the SARS-CoV-2.

Furthermore, a large controlled clinical trial is required to sort out if patients attending with a sore throat as the main complaint are best managed by medical practitioners, nurses or pharmacists. This study aims to perform such a controlled clinical trial comparing the outcome of sore throat patients management by medical practitioner, nurses and pharmacists. This study also aims to investigate to what extent the SARS-CoV-2 virus is identified in these patients.

Interventions

  • Behavioral Physicians assess patients
    Physicians are asked to assess patients following the current Swedish guideline
  • Behavioral Nurses assess patients
    Nurses are asked to assess patients following the current Swedish guideline
  • Behavioral Pharmacists assess patients
    Pharmacists are asked to assess patients following the current Swedish guideline

Primary outcome measures

  • Guideline adherence [Time frame: Immediately after the consultation]
Secondary outcome measures (3)
  • Illness severity [Time frame: Immediately after the consultation]
  • Type of patients seeking care [Time frame: Immediately after the consultation]
  • Presence of SARS-CoV-2 virus [Time frame: Immediately after the consultation]

Eligibility criteria

Inclusion criteria

  • The patient is contacting/attending PHC centre or Pharmacy presenting with a sore throat as the main complaint.
  • Male or female, aged ≥6 years.
  • Fluent in Swedish (reading, writing, conversational) (applicable to caregivers/parents/guardians in case of children).
  • Mental state such that he or she can understand and give informed consent to participation in the study by signing the Information and Consent Form.
  • Provision of signed and dated Informed Consent Form.

Exclusion criteria

  • The illness episode is classified as potentially complicated or potentially critically ill
  • Presence of SARS-CoV-2 virus in a patient first appearing at the PHC in a cluster where the assessment is supposed to be done by the pharmacists. The patient will not be sent to the pharmacist in case of presence of SARS-CoV-2-virus.
  • Patient request to be withdrawn from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 4 centers
  • Apoteket — Stenungsund
  • Närhälsan Stenungsund Vårdcentral — Stenungsund
  • Praktikertjänst Hälsobrunnen Vårdcentral — Ulricehamn
  • Apoteksgruppen — Ulricehamn

Identifiers

NCT: NCT06114706 · U1111-1299-3543

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗