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Short Course Amoxicillin for Children with Acute Streptococcal Pharyngotonsillitis: A Phase III Randomized Trial

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The condition being studied is acute streptococcal pharyngotonsillitis, a common throat infection caused by a type of bacteria that leads to sore throat, fever, and swollen tonsils. The medication tested in the study is the oral antibiotic amoxicillin, which is used to kill the bacteria that cause the infection.

The purpose of the trial is to determine whether a shorter 5‑day course of the antibiotic is not worse than the standard 7‑day course in preventing a repeat infection, called a relapse, within about two weeks after treatment ends. Children between 2 and 17 years old will be assigned by chance to receive either the 5‑day or the 7‑day regimen, take the medicine at home, and then be followed for several weeks to see if fever goes away, if symptoms return, or if any complications develop. A relapse means the infection comes back after the prescribed antibiotics have been finished.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After joining the study, a written agreement is signed to confirm participation.
The study purpose, procedures, and possible risks are explained in simple language.
Step 2
Random assignment to treatment length
The participant is randomly placed into one of two groups:
5‑day course of oral amoxicillin or 7‑day course of oral amoxicillin.
The assigned length determines how many days the medication will be taken.
Step 3
Receiving the medication
The prescribed tablets contain amoxicillin 1000 mg each.
The medication is taken by mouth as instructed by the study doctor.
Step 4
Taking the medication
The participant takes one 1000 mg tablet each day for the assigned period:
If placed in the 5‑day course, the tablets are taken for five consecutive days.
If placed in the 7‑day course, the tablets are taken for seven consecutive days.
Step 5
Monitoring symptoms during treatment
Fever is checked regularly; resolution within 48 hours is recorded as a cure.
Any signs of complications, such as pain, swelling, ear problems, or breathing difficulty, are reported to the study doctor.
Step 6
Completion of medication and short‑term observation
After the last tablet is taken, the participant continues to observe for at least 15 days.
The study looks for a relapse, defined as a new streptococcal infection occurring within 15 days after finishing the medication.
Step 7
Follow‑up visit at 15 days
A clinical assessment is performed to determine whether a relapse has occurred.
The doctor also checks for any suppurative (pus‑forming) or non‑suppurative complications.
Step 8
Extended follow‑up period
The participant is followed for up to four months after the treatment ends.
During this time, any new episodes of streptococcal throat infection, as well as delayed complications, are recorded.

Who can join the trial?

4 criteria

You are a boy or girl who is at least 2 years old and younger than 18 years.
You have a new diagnosis of strep throat (a throat infection that can cause sore throat and swollen tonsils) that was confirmed by a lab test, and your symptoms began no more than 72 hours (3 days) before starting the study medicine.
Your score on the McIsaac scale (a simple checklist doctors use to guess the chance of strep throat) is 3 or higher and you have a fever higher than 38 °C (about 100.4 °F).
Your parent or legal guardian has signed a written informed consent to let you join the study, and if you are 12 years old or older, you have also given your own agreement, called assent.

Who cannot join the trial?

13 criteria

Already taking antibiotics that work against the bacteria, such as penicillin, amoxicillin, amoxicillin‑clavulanic acid, macrolides (a group of antibiotics), or any first‑, second‑ or third‑generation cephalosporins (another type of antibiotic).
Unable to be followed up for the study, meaning you cannot attend the required visits or cannot be contacted for check‑ins.
Allergic to amoxicillin, a common antibiotic used in the trial.
Parents, legal guardians, or the patient cannot understand or follow all the study instructions and requirements.
If the doctor finds anything during the physical exam, lab tests, or other medical, social, or emotional factors that could make participation unsafe for the patient’s health.
Have taken any of the following medicines in the past 48 hours: probenecid (helps the body keep certain antibiotics), allopurinol (used for gout), tetracyclines (a class of antibiotics), oral anticoagulants (blood thinners), or methotrexate (a drug that suppresses the immune system).
Showing signs of a viral infection, such as a runny nose, cough, eye redness (conjunctivitis), hoarse voice, mouth sores (stomatitis), blisters or ulcers in the mouth, or diarrhea.
Having frequent tonsillitis, defined as seven or more episodes in one year, five or more episodes per year for two years, or three or more episodes per year for three years, and each episode must include at least one of the following: pus on the tonsils (purulent exudate), fever higher than 38°C, swollen neck lymph nodes (anterior cervical lymphadenopathy), or a positive test for the bacteria.
Having a confirmed infection with the bacteria (a rapid diagnostic test or throat culture) within the last 28 days before starting the study.
Having a personal history of serious complications from streptococcal throat infection, whether they produce pus (suppurative) or do not (non‑suppurative).
Having a personal history of invasive disease caused by the bacteria, such as bacteria in the blood (bacteremia) or infection of the brain membranes (meningitis).
Being immunocompromised, meaning the immune system is weakened and cannot fight infections well.
Being pregnant or breastfeeding.

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Verified sites

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Amoxicillin is an oral antibiotic that works by stopping the growth of bacteria that cause infections. In this study, children with a throat infection caused by streptococcus bacteria are given amoxicillin for either five days or seven days. The trial is testing whether the shorter five‑day treatment works just as well as the longer seven‑day treatment in preventing the infection from coming back. The medication is taken by mouth and is meant to clear the bacterial infection quickly and safely.

Amoxicillin

What is already known about the treatment

Amoxicillin - Amoxicillin is taken orally, usually as a tablet or liquid, and in this trial is given at a dose of 1000 mg per day for a short 5‑day course. It is a well‑established antibiotic that has been used for many years and is described in extensive medical literature. The drug is mainly used to treat acute streptococcal pharyngotonsillitis and other bacterial infections. It works by blocking the bacteria’s ability to build their cell walls, which places it in the penicillin‑type (beta‑lactam) antibiotic class.

Investigated diseases

Acute streptococcal pharyngotonsillitis - A sudden infection of the throat and tonsils caused by group A Streptococcus bacteria. It begins with a sore throat, pain when swallowing, and redness of the throat tissues. Within a few days the inflammation can spread, leading to fever, swollen lymph nodes, and sometimes a white coating on the tonsils. The condition usually peaks within three to five days and then gradually improves as the body's immune response clears the bacteria.