None listed
Conditions
Interventions
Cefaclor will be administered orally twice a day for 10 days for a total daily dose of 40mg / kg.
Group name:amoxicilin/clavulanate Type of group
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cure: Elimination of the signs and symptoms of infection without recurrence in the follow-up period, in relation to the initial symptomatic condition of the patient. Improvement: Significant but incomplete resolution of signs and symptoms of infection, in relation to the initial examination. Failure: Signs and symptoms do not diminish or improve with treatment. Relapse: There is no improvement or there is worsening of the signs and symptoms of infection after a symptomatic cure response or improvement in post-treatment evaluations. Indeterminate: Inability to evaluate a symptomatic response Measure:Efficacy Timepoints:48 hours after the first dose, day 3-5, day 11-16, day 20-26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: The safety evaluation will be performed recording adverse events at the time of the visit (s). An adverse event in a clinical trial constitutes any unfavorable medical experience that occurs in a patient who is receiving a pharmaceutical product, regardless of the possibility that there is a causal relationship. Measure:Safety Timepoints:During all control visits. | — |
Outcome results
None listed