Authorised Phase III and phase IV (Integrated) Acute otitis media

AMOXICILLIN VERSUS AMOXICILLIN-CLAVULANATE VERSUS PLACEBO IN ACUTE OTITIS MEDIA IN CHILDREN

EU CTIS ID: 2025-524259-30-00

What this study is testing

The main objective is to compare amoxicillin to placebo and amoxicillin-clavulanate in the treatment of acute otitis media in children.

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age 6-35 months and diagnosis of AOM along the prespecified criteria

You likely can't join if

  • - complicated AOM , spontaneous perforation of the tympanic membrane, known allergy to aminopenicillins, antibiotic treatment for another infectious disease, present or during 2 preceding weeks, tympanostomy tube or chronic perforation of the tympanic membrane, anatomic defect or anomaly affecting the susceptibility to AOM, immune defect, either primary or secondary, severe chronic kidney disease, known hearing defect

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.