Clinical trial • Infectious Disease

AMOXICILLIN for Acute otitis media

Clinical trial of AMOXICILLIN for Acute otitis media.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Acute otitis media
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
17-10-2025
First CTIS Authorization Date
17-02-2026

Trial design

Randomised, arms: amorion 100 mg/ml (amoxicillin) oral suspension (test); amorion comp 80 mg/ml (amoxicillin + clavulanic acid) oral suspension (comparator); syrsspend sf ph 4 (placebo). dosing units provided as mg/kg with max daily amounts: amoxicillin arm max daily 50 mg/kg (max total 350 mg/kg) for up to 7 days; amoxicillin-clavulanate arm max daily 80 mg/kg (max total 560 mg/kg) for up to 7 days. placebo matched formulation (syrsspend).-controlled trial across 3 sites in Finland.

Randomised
Yes
Comparator
Arms: Amorion 100 mg/ml (amoxicillin) oral suspension (test); Amorion Comp 80 mg/ml (amoxicillin + clavulanic acid) oral suspension (comparator); SyrsSpend SF pH 4 (placebo). Dosing units provided as mg/kg with max daily amounts: Amoxicillin arm max daily 50 mg/kg (max total 350 mg/kg) for up to 7 days; Amoxicillin-clavulanate arm max daily 80 mg/kg (max total 560 mg/kg) for up to 7 days. Placebo matched formulation (SyrsSpend).
Target Sample Size
219
Trial Duration For Participant
14

Eligibility

Recruits 219 paediatric patients.

Vulnerable Population
Trial population includes children aged 6-35 months (paediatric population). Subject information and informed consent documents are present in the record. Informed consent is obtained from parent(s)/legal guardian(s); assent is not applicable/not mentioned for this age group.

Inclusion criteria

  • {"criterion_text":"- Age 6-35 months and diagnosis of AOM along the prespecified criteria"}

Exclusion criteria

  • {"criterion_text":"- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary outcome is condition of the child, measured daily in days 1-7 and at days 10 and 14 with AOM-SOS score version 6.0. The treatment effectiveness measured as risk ratios and generalized estimation equations (GEE) are used to convert the daily mean comparisons into relative effect estimates","definition_or_measurement_approach":"Condition measured daily days 1-7 and at days 10 and 14 using the AOM-SOS score version 6.0; treatment effectiveness analysed as risk ratios and using generalized estimation equations (GEE) to convert daily mean comparisons into relative effect estimates."}

Secondary endpoints

  • {"endpoint_text":"- needing rescue antibiotics\n- with no improvement of overall condition by the first scheduled control visit (day 2-4)\n- with no improvement of otoscopic signs (7-9 day visit)\n- with middle ear effusion at days 2, 7 and 14\n- with development of contralateral AOM during the treatment\n- with spontaneous perforation of the tympanic membrane during the treatment\n- with side effects (for ex. diarrhea, rash)","definition_or_measurement_approach":"Secondary outcomes are measured as proportions of children meeting each listed outcome at the specified visits/timepoints (e.g., first scheduled control visit day 2-4; otoscopic signs at day 7-9; middle ear effusion at days 2, 7 and 14)."}

Recruitment

Planned Sample Size
219
Recruitment Window Months
36
Consent Approach
Informed consent documents and subject information forms are included in the dossier. Consent is obtained from parent(s)/legal guardian(s) for participants (children aged 6-35 months). Documents available include Finnish-language subject information and consent forms (titles in Finnish). Assent is not applicable/not mentioned for this age group.

Geography

Total Number Of Sites
3
Total Number Of Participants
219

Finland

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
127
Number Of Sites
3
Number Of Participants
219

Sites

Site Name
Kuopio University Hospital
Department Name
Pediatrics and Adolescents
Principal Investigator Name
Marjo Renko
Principal Investigator Email
marjo.renko@uef.fi
Contact Person Name
Marjo Renko
Contact Person Email
marjo.renko@uef.fi
Site Name
Turku University Hospital
Department Name
Pediatrics and Adolescents
Principal Investigator Name
Paula Tähtinen
Principal Investigator Email
paula.tahtinen@utu.fi
Contact Person Name
Paula Tähtinen
Contact Person Email
paula.tahtinen@utu.fi
Site Name
Mikkeli Central Hospital
Department Name
Emergency
Principal Investigator Name
Harri Hyppölä
Principal Investigator Email
harri.hyppola@uef.fi
Contact Person Name
Harri Hyppölä
Contact Person Email
harri.hyppola@uef.fi

Sponsor

Primary sponsor

Full Name
Pohjois-Savon hyvinvointialue
Organisation Type
Patient organisation/association
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Amorion 100 mg/ml jauhe oraalisuspensiota varten
Active Substance
AMOXICILLIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised (marketing authorisation number 16734; EU MP PRD11808814)
Maximum Dose
Max daily 50 mg/kg; max total 350 mg/kg
Investigational Product Name
Amorion Comp 80 mg/ml jauhe oraalisuspensiota varten
Active Substance
AMOXICILLIN; CLAVULANIC ACID
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised (marketing authorisation number 24781; EU MP PRD11809647)
Maximum Dose
Max daily 80 mg/kg; max total 560 mg/kg
Investigational Product Name
SyrsSpend SF pH 4
Active Substance
None (placebo)
Modality
Other (placebo)
Combination Treatment
Yes

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