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Study on Phenoxymethylpenicillin for Patients with Severe Streptococcus Group A-Negative Acute Tonsillitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying acute tonsillitis, which is an inflammation of the tonsils often causing a sore throat and difficulty swallowing. The study is specifically looking at cases where the tonsillitis is not caused by Streptococcus group A, a common type of bacteria. The treatment being tested is an antibiotic called phenoxymethylpenicillin, which is being compared to not using any antibiotic treatment at all.

The purpose of the study is to determine if taking phenoxymethylpenicillin can reduce the duration of symptoms in patients with severe symptoms of acute tonsillitis. Participants in the study will either receive the antibiotic or no antibiotic treatment, and the researchers will observe how long it takes for their symptoms to resolve. The study will involve regular check-ins to monitor the progress of symptoms over a period of time.

This trial is designed to help understand whether using an antibiotic like phenoxymethylpenicillin is beneficial for treating severe cases of acute tonsillitis that are not caused by Streptococcus group A. The findings could provide valuable insights into the best treatment practices for this condition in primary health care settings.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be 15 years or older, experiencing a sore throat or pain when swallowing, and have a Centor score of 3-4. This score includes symptoms such as absence of cough, fever above 38.5°C, tender lymph nodes, and tonsillar exudates.

    Symptoms must have been present for less than 8 days, and a rapid antigen detection test (RADT) for group A Streptococcus (GAS) is conducted. Informed consent is required, and for those under 18, consent from both parents or caretakers is also necessary.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups. One group receives phenoxymethylpenicillin, while the other group does not receive any antibiotic treatment. This is to compare the effects of the antibiotic with usual care.

  3. Step 3

    Medication administration

    For those in the antibiotic group, phenoxymethylpenicillin is administered orally. The dosage and frequency are determined by the study protocol, which is not specified in the provided data.

  4. Step 4

    Monitoring symptoms

    Participants are monitored for the duration of their symptoms. The primary goal is to observe the number of days from joining the study to the resolution of symptoms. This is measured to determine the effectiveness of the antibiotic compared to no treatment.

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 30, 2024. Participants' data will be analyzed to assess the differences in symptom duration between the two groups.

Who can join the trial?

9 criteria

  • Must be an adult or young adult aged 15 years or older.
  • Must have symptoms of a sore throat or pain when swallowing.
  • Must have a Centor score of 3-4, which means:
    • No cough.
    • History of fever with a temperature above 38.5°C.
    • Tender lymphadenitis, which means swollen and painful lymph nodes.
    • Tonsillar exudates, which means a white or yellow coating on one or both tonsils.
    • Symptoms must have lasted less than 8 days.
    • A RADT for GAS must be taken. This is a rapid test to check for a specific type of bacteria in the throat.
    • Must be willing and able to give informed consent. If under 18, both parents or caretakers must also give consent.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing severe symptoms of tonsillitis, which is an infection of the tonsils, cannot participate.
  • Patients who have a positive test for GAS (Group A Streptococcus), a type of bacteria, are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not included.
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Investigated drugs

Phenoxymethylpenicillin is an antibiotic used to treat bacterial infections. In this clinical trial, it is being tested to see if it can reduce the duration of symptoms in patients with severe acute tonsillitis that is not caused by Streptococcus group A bacteria. The trial aims to compare the effects of this antibiotic with no antibiotic treatment to determine its effectiveness in primary health care settings.

What is already known about the treatment

Phenoxymethylpenicillin – This medication is administered orally, typically in the form of tablets or liquid suspension. It is currently well-established in medical practice and literature as an effective antibiotic. The main therapeutic indication for phenoxymethylpenicillin is the treatment of bacterial infections, such as tonsillitis, especially when caused by Streptococcus bacteria. At the molecular level, it works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It is classified pharmacologically as a penicillin antibiotic.

Investigated diseases

Tonsillitis – Tonsillitis is an inflammation of the tonsils, which are two lymph nodes located at the back of the throat. It is commonly caused by viral or bacterial infections. Symptoms often include a sore throat, difficulty swallowing, and swollen tonsils. The condition can also lead to fever, headache, and a hoarse voice. In some cases, the tonsils may appear red and have white or yellow spots. The disease typically progresses with symptoms worsening over a few days before gradually improving.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508542-18-00Protocol codeSANT-trialEstimated enrolment390 patientsSponsorRegion Joenkoepings Laen

sourced from the EU Clinical Trials Register and site verification

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