Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
NCT ID: NCT04083417
Last Updated: 2024-12-04
Study Results
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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RECRUITING
PHASE4
260 participants
INTERVENTIONAL
2019-09-09
2026-06-30
Brief Summary
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Studies that have identified microorganisms in sore throat show that there are other bacteria and viruses than GAS, that give similar symptoms and that sometimes no microorganism is trapped despite pronounced symptoms. In recent years, a bacterium F. necrophorum has been identified, which is found in increased incidence of sore throat, but it is also found in healthy individuals. In clinical practice, many patients are treated with penicillin even if GAS is not captured. This may be because the doctor perceives the patient as sick or because other bacteria are not caught with a near patient test which causes the doctor to treat anyway.
The specific aims are to in patients with GAS-negative sore throat and 3 and 4 criteria, aged 15 years and older in primary care, study whether phenoxymethylpenicillin treatment shortens the duration of the disease, reduces the symptom intensity and sickness absence, and investigates the importance of other microorganisms than GAS in sore throat.
The study is a randomized controlled trial in which patients with sore throat are randomized to phenoxymethylpenicillin 3 times daily for 10 days or to no antibiotic therapy. There will also be and a reference group with severe (Centor score 3-4), GAS-positive acute tonsillitis.
Blood samples for inflammatory and immunological response to infections are taken. Throat samples for culture of F. necrophorum and streptococcal groups C and G, as well as polymerase chain reaction (PCR) analysis for bacteria and viruses are also taken at inclusion and at follow-up.
The outcome will be followed in a patient diary for 10 days and at a return visit after 18-24 days where the clinical outcome is asked for and where the blood- and throat samples are repeated.
Follow-up will also takes place via e-mail after 1 and 3 months.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Phenoxymethylpenicillin group
Patients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days
Phenoxymethylpenicillin
tablet PcV 1000 mg x 3 for 10 days
No antibiotic treatment group
Patients randomized to no antibiotic treatment
No antibiotic treatment
No prescription of antibiotics
Interventions
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Phenoxymethylpenicillin
tablet PcV 1000 mg x 3 for 10 days
No antibiotic treatment
No prescription of antibiotics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Duration of symptoms \< 8 days
* Rapid antigen detection test for GAS taken and negative
* Willing and able to give informed consent. Subjects under 18 years of age must in addition have the consent from both parents/caretakers
Exclusion Criteria
* Known or suspected allergies to phenoxymethylpenicillin
* Suspicion of peritonsillar abscess or indication for admittance.
15 Years
ALL
No
Sponsors
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Umeå University
OTHER
Linkoeping University
OTHER_GOV
Lund University
OTHER
Region Jönköping County
UNKNOWN
Katarina Hedin
OTHER_GOV
Responsible Party
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Katarina Hedin
Adjunct professor
Principal Investigators
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Katarina Hedin, Ass Prof
Role: PRINCIPAL_INVESTIGATOR
Region Jönköping County
Locations
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Vårdcentralen Rosenhälsan
Jönköping, , Sweden
Vårdcentralen Kärna
Linköping, , Sweden
Vårdcentralen Lundbergsgatan
Malmo, , Sweden
Mariehems hälsocentral
Umeå, , Sweden
Ålidhems hälsocentral
Umeå, , Sweden
Vårdcentralen Skärvet
Vaxjo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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David Tell, MD
Role: primary
Anna Moberg, MD
Role: primary
Mia Tyrstrup, MD,PhD
Role: primary
Kia Ericsson, MD
Role: primary
Helena Lönneborg, MD
Role: primary
Jon Pallon, MD, PhD
Role: primary
Other Identifiers
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2019-000756-34
Identifier Type: -
Identifier Source: org_study_id