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Best Assessment of Sore Throat and Antibiotic Prescribing

Best Assessment of Sore Throat and Antibiotic Prescribing

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06114706
Acronym
BASTA
Enrollment
450
Registered
2023-11-02
Start date
2024-03-04
Completion date
2027-06-30
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis

Keywords

Guideline, Sore throat, Pharmacy, Nurses, Physicians

Brief summary

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

BEHAVIORALPhysicians assess patients

Physicians are asked to assess patients following the current Swedish guideline

BEHAVIORALNurses assess patients

Nurses are asked to assess patients following the current Swedish guideline

BEHAVIORALPharmacists assess patients

Pharmacists are asked to assess patients following the current Swedish guideline

Sponsors

Vastra Gotaland Region
Lead SponsorOTHER_GOV
Göteborg University
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Parallel groups each with different interventions.

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Guideline adherenceImmediately after the consultationWill 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

MeasureTime frameDescription
Illness severityImmediately after the consultationWhat proportion of patients attending PHC centres or pharmacies are classified as apparently uncomplicated, potentially complicated or potentially critically ill
Type of patients seeking careImmediately after the consultationWill patient characteristics differ if the patient first appears to the medical practitioner, a trained nurse or a trained pharmacist?
Presence of SARS-CoV-2 virusImmediately after the consultationTo what extent do patients attending Primary Health Care/Pharmacies due to an acute sore throat harbour the SARS-CoV-2 virus?

Countries

Sweden

Contacts

CONTACTCarl Wikberg, PhD
carl.wikberg@allmed.gu.se+46703821660
PRINCIPAL_INVESTIGATORRonny Gunnarsson, PhD

University of Gothenburg and Region Vastra Gotaland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026