Actively Recruiting
A Randomized Controlled Trial Comparing Phenoxymethylpenicillin and No Antibiotic Treatment for Group A Streptococci-Negative Acute Tonsillitis in Primary Care
Led by Katarina Hedin · Updated on 2024-12-04
260
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Katarina Hedin
Lead Sponsor
U
Umeå University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying sore throat, a common reason for antibiotic use in primary care, focusing on patients aged 15 years and older with sore throat symptoms but negative tests for group A streptococci (GAS). The trial aims to evaluate whether phenoxymethylpenicillin shortens the illness duration, reduces symptom severity, and decreases time off work or school. The study also explores the role of other bacteria and viruses in sore throat cases where GAS is not detected. Participants are randomly assigned to receive either oral phenoxymethylpenicillin tablets (1000 mg three times daily for 10 days) or no antibiotic treatment. There is also a reference group of patients with severe GAS-positive tonsillitis. Blood and throat samples are collected at the start and during follow-up to analyze inflammatory responses and identify bacteria or viruses present, including Fusobacterium necrophorum and streptococcal groups C and G. Participants keep a symptom diary for 10 days and return for a follow-up visit 18 to 24 days after starting the study to review clinical outcomes and repeat testing. Additional follow-up occurs via email at 1 and 3 months to monitor symptom resolution and recurrence. The main outcome measured is the number of days from study entry until symptoms resolve, along with other symptom and recovery assessments and monitoring for any adverse events.
CONDITIONS
Brief Title
Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 15 years or older
- Sore throat with Centor score 3-4: no cough, fever over 38.5°C, tender cervical lymph nodes, and tonsillar exudates
- Symptoms lasting less than 8 days
- Negative rapid antigen detection test for group A streptococci
- Willing and able to give informed consent; participants under 18 require consent from both parents or caretakers
You will not qualify if you...
- Currently receiving antibiotic treatment
- Known or suspected allergy to phenoxymethylpenicillin
- Suspected peritonsillar abscess or need for hospital admission
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive either phenoxymethylpenicillin tablets three times daily for 10 days or no antibiotic treatment to compare symptom resolution.
1 baseline visit and daily self-reporting during treatment
Duration - Up to 3 months after treatment
Participants are followed up for assessment of symptom resolution, future sore throat episodes, pathogen eradication, and adverse events.
Visits or contacts at 18-24 days, 30 days, and 3 months after inclusion
Trial Site Locations
Total: 6 locations
1
Vårdcentralen Rosenhälsan
Jönköping, Sweden, 551 85
Actively Recruiting
2
Vårdcentralen Kärna
Linköping, Sweden, 586 62
Actively Recruiting
3
Vårdcentralen Lundbergsgatan
Malmö, Sweden, 217 51
Actively Recruiting
4
Mariehems hälsocentral
Umeå, Sweden, 906 51
Not Yet Recruiting
5
Ålidhems hälsocentral
Umeå, Sweden, 907 36
Not Yet Recruiting
6
Vårdcentralen Skärvet
Vaxjo, Sweden, 352 36
Actively Recruiting
Research Team
K
Katarina Hedin, Ass Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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