Comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old children

Clinical trial of the effectiveness of comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20111224008507N2

Enrollment

200

Registered

2018-07-09

Start date

2017-05-22

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

Otitis media. Other acute nonsuppurative otitis media

Interventions

Intervention 1: Intervention group: For the intervention group, 80 mg/kg/day Amoxicillin suspension manufactured by Farabi co. with brand name of Faramox BD will be given for at least 7 days. Interven

Eligibility

Sex/Gender

All

Age

6 Months to 6 Years

Inclusion criteria

Inclusion criteria: Age 6 months to 6 years Acute otitis media with signs started within 48 hours Not having severe symptoms and ear otorrhea Unilateral or bilateral involvement

Exclusion criteria

Exclusion criteria: Severe otalgia Fever higher than 39 degrees Underlying diseases such as immunodeficiency (except asthma and allergy) Amoxicillin intake in the last 30 days Concurrent conjunctivitis Ear otorrhea

Design outcomes

Primary

Measure	Time frame
Fever. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Thermometer.;Otalgia. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Observation.;Mastoiditis. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination.;Middle ear effusion. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination.	—

Measure

Time frame

Fever. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Thermometer.;Otalgia. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Observation.;Mastoiditis. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination.;Middle ear effusion. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination.

—

Secondary

Measure	Time frame
Frequency of acute otitis media. Timepoint: One and three months after treatment. Method of measurement: Observation.;Middle ear effusion. Timepoint: One and three months after treatment. Method of measurement: Examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEnsieh Talaei

Sari University of Medical Sciences

nasimmeh62@yahoo.com+98 11 3334 2334

Outcome results

None listed

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