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

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What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country	Status
Turku University Hospital	Turku	Finland
Mepprgy Ctuoxbq Hbccpgik	Mikkeli	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.01.2026

Trial locations

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.

Investigated diseases:

Otitis media

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 ID:

2025-524259-30-00

Protocol code:

SAVOtitis trial

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?