Comparing phenoxymethylpenicillin and no treatment for sore throat
A Randomized Controlled Clinical Trial of Streptococcus Group A-negative Acute Tonsillitis in Primary Health Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
This study tests if taking phenoxymethylpenicillin helps people with sore throats and tonsillitis feel better compared to not taking any antibiotics at all.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Region Jönköping County Government |
| Locations | 6 sites (Jönköping and 5 other locations) |
| Trial ID | NCT04083417 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of phenoxymethylpenicillin compared to no antibiotic treatment for patients with sore throat and tonsillitis in primary care settings. It focuses on patients who meet specific clinical criteria, including a Centor score of 3-4 and a negative rapid antigen test for group A streptococcus. The aim is to determine whether antibiotic treatment is necessary in cases where other bacteria may be present or no microorganisms are detected. The study seeks to provide clarity on antibiotic prescribing practices for sore throat in primary care.
Who should consider this trial
Good fit: Ideal candidates are adults with a sore throat who meet the Centor criteria and have tested negative for group A streptococcus.
Not a fit: Patients currently on antibiotic treatment or with known allergies to phenoxymethylpenicillin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more appropriate antibiotic prescribing practices, reducing unnecessary antibiotic use and its associated risks.
How similar studies have performed: Other studies have explored antibiotic use for sore throat, but this specific comparison of phenoxymethylpenicillin and no treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ' Centor score 3-4: absence of cough, anamnestic fever (temperature \>38.5°C), tender cervical lymphadenitis, and tonsillar exudates (one or both tonsils) * 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: * Ongoing antibiotic treatment * Known or suspected allergies to phenoxymethylpenicillin * Suspicion of peritonsillar abscess or indication for admittance.
Where this trial is running
Jönköping and 5 other locations
- Vårdcentralen Rosenhälsan — Jönköping, Sweden (Recruiting)
- Vårdcentralen Kärna — Linköping, Sweden (Recruiting)
- Vårdcentralen Lundbergsgatan — Malmö, Sweden (Recruiting)
- Mariehems hälsocentral — Umeå, Sweden (Not_yet_recruiting)
- Ålidhems hälsocentral — Umeå, Sweden (Not_yet_recruiting)
- Vårdcentralen Skärvet — Vaxjo, Sweden (Recruiting)
Study contacts
- Principal investigator: Katarina Hedin, Ass Prof — Region Jönköping County
- Study coordinator: Katarina Hedin, Ass Prof
- Email: katarina.hedin@rjl.se
- Phone: +46761369019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.