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Comparison of amoxicillin, amoxicillin-clavulanate, and placebo for the treatment of middle ear infection in children

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What is this trial about?

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

This study is being conducted to compare different treatment options for Acute Otitis Media, which is a common type of ear infection. The research will evaluate the effectiveness of amoxicillin, a type of antibiotic, compared to amoxicillin combined with clavulanic acid, and a placebo.

During the study, participants will be assigned to receive one of the three different options. The treatment is provided as an oral suspension, which is a liquid medicine taken by mouth. The process involves monitoring the condition of the children over a period of time to see how they respond to the different medications.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment assignment</b>

    After joining the study, one of three different treatment options is assigned. these options are amoxicillin, amoxicillin-clavulanate, or a placebo, which is a substance that does not contain active medicine.

  2. Step 2

    <b>medication administration</b>

    If assigned the amoxicillin (test) group, the dosage is 50 mg/kg (milligrams per kilogram of body weight) administered as an oral suspension (liquid medicine taken by mouth).

    If assigned the amoxicillin-clavulanate (comparator) group, the dosage is 80 mg/kg administered as an oral suspension (liquid medicine taken by mouth).

    If assigned the placebo group, the product syrspend sf ph 4 is used.

  3. Step 3

    <b>monitoring and evaluation</b>

    The condition of the child is monitored daily from day 1 to day 7, and again on day 10 and day 14 using a specific scoring system for acute otitis media (a sudden ear infection).

    Medical assessments are conducted to check for improvement in condition and otoscopic signs (signs seen in the ear during an examination).

    Checks are performed on days 2, 7, and 14 to look for middle ear effusion (fluid trapped behind the eardrum).

    The child is monitored for side effects, such as diarrhea or rash, and for any spontaneous perforation of the tympanic membrane (an accidental tear in the eardrum) during the treatment period.

    Observations are made regarding whether rescue antibiotics (additional medicine needed if the first treatment fails) are required or if an ear infection develops in the opposite ear.

Who can join the trial?

2 criteria

  • You must be between 6 and 35 months old.
  • You must have been diagnosed with acute otitis media, which is a common type of ear infection that happens suddenly.

Who cannot join the trial?

9 criteria

  • Having complicated acute otitis media, which is a middle ear infection that is more severe or difficult to treat than a standard ear infection.
  • Having a spontaneous perforation of the tympanic membrane, which means a hole has formed in the eardrum without an injury.
  • A known allergy to aminopenicillins, which is a specific group of antibiotics that may cause an allergic reaction.
  • Receiving antibiotic treatment for a different infection either currently or within the last two weeks.
  • Having tympanostomy tubes (small tubes placed in the eardrum to help drain fluid) or a chronic perforation (a hole in the eardrum that does not heal on its own).
  • Having an anatomic defect or anomaly, which means a physical difference in the structure of the ear that makes it more likely to get ear infections.
  • Having an immune defect, which is a problem with the body's natural defense system against germs, whether it is something a person is born with or something they developed later.
  • Having severe chronic kidney disease, which is a long-term condition where the kidneys do not work properly.
  • Having a known hearing defect, which refers to any existing problem with the ability to hear.
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Investigated drugs

  • Amoxicillin

    is an antibiotic used to treat infections caused by bacteria. In this study, it is being tested to see how well it works to treat ear infections in children.

  • Amoxicillin and clavulanic acid

    is a combination antibiotic used to treat bacterial infections. It contains two different medicines that work together to help fight bacteria that might be resistant to other treatments, and it is being used here to compare its effectiveness against the other treatments for ear infections.

What is already known about the treatment

  • SyrsSpend SF pH 4

    This substance is a placebo, which means it contains no active medicine and is used as a control in clinical studies. It is administered in a way that mimics the test medication but serves no therapeutic purpose. It is used in research to help determine if the actual drugs being tested are truly effective.

  • Amorion Comp 80 mg/ml

    This medication is an oral suspension taken by mouth to treat bacterial infections like middle ear infections in children. It is a widely used combination antibiotic consisting of amoxicillin and clavulanic acid. The amoxicillin works by preventing bacteria from building their protective cell walls, while the clavulanic acid stops bacteria from using certain enzymes that would otherwise destroy the antibiotic.

  • Amorion 100 mg/ml

    This medication is an oral suspension taken by mouth used to treat bacterial infections such as ear infections. It contains amoxicillin, a common antibiotic that is well-established in medical practice for fighting various bacterial illnesses. At a molecular level, it works by interfering with the ability of bacteria to create their protective outer layers, causing them to break apart and die.

Investigated diseases

Acute otitis media - This is an infection of the middle ear, which is the air-filled space behind the eardrum. It often occurs following a viral infection that causes fluid to build up in the ear. The buildup of fluid can lead to pressure and inflammation in the ear canal. Symptoms typically include ear pain and redness visible through the eardrum. If left unmanaged, the infection can cause fluid to remain trapped in the middle ear. In some cases, the pressure may lead to a small tear in the eardrum.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2025-524259-30-00Protocol codeSAVOtitis trialEstimated enrolment219 patientsSponsorPohjois-Savon hyvinvointialue

sourced from the EU Clinical Trials Register and site verification

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