PharyngitisBASTANCT06114706
Best Assessment of Sore Throat and Antibiotic Prescribing
A study testing Physicians assess patients, Nurses assess patients and Pharmacists assess patients in people with Pharyngitis, run by Vastra Gotaland Region at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Physicians assess patients, Nurses assess patients and Pharmacists assess patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 4 sitesSweden
- Study dates
- 4 Mar 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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- Patient request to be withdrawn from the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Apoteket
Stenungsund, 4430
Mina Khalil
- Recruiting
Närhälsan Stenungsund Vårdcentral
Stenungsund, 44430
Annelie Jardek
- Recruiting
Praktikertjänst Hälsobrunnen Vårdcentral
Ulricehamn, 52337
Dennis Johansson
- Recruiting
Apoteksgruppen
Ulricehamn
Sofia Pihlgren
About this study
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.
Read the 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.
- Conditions
- Pharyngitis
- Being tested
- Physicians assess patients, Nurses assess patients, Pharmacists assess patients
- Keywords
- Guideline, Sore throat, Pharmacy, Nurses, Physicians
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physicians assess patientsBehavioural
Physicians are asked to assess patients following the current Swedish guideline
Nurses assess patientsBehavioural
Nurses are asked to assess patients following the current Swedish guideline
Pharmacists assess patientsBehavioural
Pharmacists are asked to assess patients following the current Swedish guideline
| Study group | Role | What they receive |
|---|---|---|
| Initial assessement by physicians | Active comparator | Patients attending with an acute sore throat are initially assessed by a physician. This is one variant of current standard practice. Receives: Behavioral: Physicians assess patients |
| Initial assessement by nurses | Active comparator | Patients attending with an acute sore throat are initially assessed by a nurse. This is one variant of current standard practice. Receives: Behavioral: Nurses assess patients |
| Initial assessement by pharmacists | Experimental | Patients attending with an acute sore throat are initially assessed by a pharmacist. This is officially not standard practice in Sweden, although it happens. Receives: Behavioral: Pharmacists assess patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the consultation
Secondary outcomes (3)
Illness severity
What proportion of patients attending PHC centres or pharmacies are classified as apparently uncomplicated, potentially complicated or potentially critically ill
Measured: Immediately after the consultation
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?
Measured: Immediately after the consultation
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?
Measured: Immediately after the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start4 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel groups each with different interventions.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Ronny Gunnarsson, PhD, Principal investigator, University of Gothenburg and Region Vastra Gotaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114706
- Sponsor's protocol ID
- U1111-1299-3543
- Acronym
- BASTA
- Status last verified
- Mar 2026
- First submitted
- 23 Oct 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Assessment of Sore Throat and Antibiotic Prescribing
- ClinicalTrials.gov ID
- NCT06114706
- Acronym / sponsor ID
- BASTA / U1111-1299-3543
- Conditions
- Pharyngitis
- Keywords
- Guideline, Sore throat, Pharmacy, Nurses, Physicians
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel groups each with different interventions.
| Arm | Type | Receives |
|---|---|---|
| Initial assessement by physicians | Active comparator | Behavioral: Physicians assess patientsPatients attending with an acute sore throat are initially assessed by a physician. This is one variant of current standard practice. |
| Initial assessement by nurses | Active comparator | Behavioral: Nurses assess patientsPatients attending with an acute sore throat are initially assessed by a nurse. This is one variant of current standard practice. |
| Initial assessement by pharmacists | Experimental | Behavioral: Pharmacists assess patientsPatients attending with an acute sore throat are initially assessed by a pharmacist. This is officially not standard practice in Sweden, although it happens. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physicians assess patientsPhysicians are asked to assess patients following the current Swedish guideline | Behavioural | Initial assessement by physicians |
| Nurses assess patientsNurses are asked to assess patients following the current Swedish guideline | Behavioural | Initial assessement by nurses |
| Pharmacists assess patientsPharmacists are asked to assess patients following the current Swedish guideline | Behavioural | Initial assessement by pharmacists |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronny Gunnarsson, PhD principal investigator
University of Gothenburg and Region Vastra Gotaland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physicians assess patients, Nurses assess patients and Pharmacists assess patients in people with Pharyngitis, run by Vastra Gotaland Region at 4 sites in Sweden.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Wikberg, PhD (+46703821660, carl.wikberg@allmed.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline adherence (time frame: Immediately after the consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.