Randomised controlled trial of effect of antibiotic dose on antibiotic resistance in young children with otitis media

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004290-29-GB

Enrollment

220

Registered

2005-02-15

Start date

2004-11-29

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute otitis media

Interventions

Trade Name: Amoxicillin (non-proprietary) Product Name: Amoxicillin Pharmaceutical Form: Oral suspension INN or Proposed INN: amoxicillin trihydrate Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Acute Otitis Media Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No antibiotics prescribed in the previous 14 days

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the acquisition of resistance in Haemophilus sp. in children prescribed 2 day high dose and 7 day standard dose antibiotic treatments;Secondary Objective: ;Primary end point(s): Measurement of antibiotic resistance in isolates of Haemophilus sp.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026