Best Assessment of Sore Throat and Antibiotic Prescribing

Pharyngitis Clinical Trial

— BASTA  

Official title:

Best Assessment of Sore Throat and Antibiotic Prescribing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114706
• Other study ID #: U1111-1299-3543
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Vastra Gotaland Region
• Contact: Carl Wikberg, PhD
• Phone: +46703821660
• Email: carl.wikberg[@]allmed.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pharyngitis

Intervention

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

Locations

Country	Name	City	State
Sweden	Apoteket	Stenungsund
Sweden	Närhälsan Stenungsund Vårdcentral	Stenungsund
Sweden	Apoteksgruppen	Ulricehamn
Sweden	Praktikertjänst Hälsobrunnen Vårdcentral	Ulricehamn

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guideline adherence	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	Immediately after the consultation
Secondary	Illness severity	What proportion of patients attending PHC centres or pharmacies are classified as apparently uncomplicated, potentially complicated or potentially critically ill	Immediately after the consultation
Secondary	Type of patients seeking care	Will patient characteristics differ if the patient first appears to the medical practitioner, a trained nurse or a trained pharmacist?	Immediately after the consultation
Secondary	Presence of SARS-CoV-2 virus	To what extent do patients attending Primary Health Care/Pharmacies due to an acute sore throat harbour the SARS-CoV-2 virus?	Immediately after the consultation