CEFACLOR VS AMOXICILLINE / CLAVULANATE IN THE TREATMENT OF MEDIUM ACUTE OTITIS WITH EFUSIO

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Subjects must be diagnosed with AOME during enrollment
• The researcher will attempt to select those subjects and parents or guardians who have a history of complying with instructions.
• The subjects will be male and female, from 3 months to under 13 years of age, and weigh at least 5.5 kg. (12 Ibs.) But not more than 40 kg. (88lbs).
• Parents or guardians must sign an informed consent approved by an ethical review committee.

Exclusion Criteria

• Researchers and their immediate families will be excluded as subjects of the study. The immediate family is defined as the current wife, father, natural or adopted child (including the stepchild who lives in the researcher´s home), grandparent, or grandchild.
• Treatment with a drug within the last 30 days that has not received regulatory approval at the time of entry into the study.
• Subjects with phenylketonuria.
• Subjects with serous otitis media.
• History of significant renal failure.
• Any condition, including significant current illness or concomitant infection that, in the opinion of the investigator, could prevent the response evaluation, including but not limited to; chronic diarrhea, irritable bowel, or malabsorption syndrome.
• The anticipated requirement of systemic antibiotics other than the study antibiotic after the pre-therapy evaluation and before the post-therapy evaluation.
• Subject´s inability to return to follow-up evaluations.
• Hypersensitivity to cephalosporins or penicillins.
• Spontaneous drilling of the eardrum membrane and drainage for more than 24 hours to the evaluation of the pre-therapy.
• Systemic anti-infective medication in the 7 days prior to enrollment.
• Subjects with tympanostomy tubes.
• Signs or symptoms of meningitis or mastoiditis.
• Previous enrollment in this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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