Actively Recruiting

Phase 4
Age: 15Years +
All Genders
ID04083417

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

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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