Best Assessment of Sore Throat and Antibiotic Prescribing

NCT ID: NCT06114706

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Pharyngitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel groups each with different interventions.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Initial assessement by physicians

Patients attending with an acute sore throat are initially assessed by a physician. This is one variant of current standard practice.

Group Type ACTIVE_COMPARATOR

Physicians assess patients

Intervention Type BEHAVIORAL

Physicians are asked to assess patients following the current Swedish guideline

Initial assessement by nurses

Patients attending with an acute sore throat are initially assessed by a nurse. This is one variant of current standard practice.

Group Type ACTIVE_COMPARATOR

Nurses assess patients

Intervention Type BEHAVIORAL

Nurses are asked to assess patients following the current Swedish guideline

Initial assessement by pharmacists

Patients attending with an acute sore throat are initially assessed by a pharmacist. This is officially not standard practice in Sweden, although it happens.

Group Type EXPERIMENTAL

Pharmacists assess patients

Intervention Type BEHAVIORAL

Pharmacists are asked to assess patients following the current Swedish guideline

Interventions

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Physicians assess patients

Physicians are asked to assess patients following the current Swedish guideline

Intervention Type BEHAVIORAL

Nurses assess patients

Nurses are asked to assess patients following the current Swedish guideline

Intervention Type BEHAVIORAL

Pharmacists assess patients

Pharmacists are asked to assess patients following the current Swedish guideline

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronny Gunnarsson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Gothenburg and Region Vastra Gotaland

Locations

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Apoteket

Stenungsund, , Sweden

Site Status RECRUITING

Närhälsan Stenungsund Vårdcentral

Stenungsund, , Sweden

Site Status RECRUITING

Praktikertjänst Hälsobrunnen Vårdcentral

Ulricehamn, , Sweden

Site Status RECRUITING

Apoteksgruppen

Ulricehamn, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Carl Wikberg, PhD

Role: CONTACT

+46703821660

Facility Contacts

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Mina Khalil

Role: primary

Annelie Jardek

Role: primary

Dennis Johansson

Role: primary

Sofia Pihlgren

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1299-3543

Identifier Type: -

Identifier Source: org_study_id

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