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NCT Number: NCT06114706

Best Assessment of Sore Throat and Antibiotic Prescribing

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.

Recruiting

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Apoteket, Stenungsund, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physicians assess patients

Behavioral

Physicians are asked to assess patients following the current Swedish guideline

Nurses assess patients

Behavioral

Nurses are asked to assess patients following the current Swedish guideline

Pharmacists assess patients

Behavioral

Pharmacists are asked to assess patients following the current Swedish guideline

Primary outcomes

  1. Guideline adherence

    Time frame: Immediately after the consultation

    Will the proportion of patients attending for an uncomplicated acute sore throat being managed according to prevailing guidelines differ if the initial assessment is made by a medical practitioner, a trained nurse or a trained pharmacist

Secondary outcomes

  1. Illness severity

    Time frame: Immediately after the consultation

    What proportion of patients attending PHC centres or pharmacies are classified as apparently uncomplicated, potentially complicated or potentially critically ill

  2. Type of patients seeking care

    Time frame: Immediately after the consultation

    Will patient characteristics differ if the patient first appears to the medical practitioner, a trained nurse or a trained pharmacist?

  3. Presence of SARS-CoV-2 virus

    Time frame: Immediately after the consultation

    To what extent do patients attending Primary Health Care/Pharmacies due to an acute sore throat harbour the SARS-CoV-2 virus?

Study contacts

Contact information is provided by the study sponsor or research team.

Carl Wikberg, PhD

CONTACT

[email protected]

+46703821660

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Acronym: BASTA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 2, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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