None listed
Conditions
Interventions
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients must be diagnosed with acute otitis with effusion • The researcher will select those patients with parents or guardians who follow the medical indications. • Patients, between 6 months and 12 years of age, and at least 5.5 kg in weight. • Parents or Guardians must sign an informed consent approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: • Researchers and immediate family members. The immediate family is defined as the researcher´s wife, parents, children, grandchildren or grandparents. • Treatment with any medication within the last 30 days that has not been approved at the time of admission to the study. • Patients with a history of serous otitis media, chronic media otits, cholesteatoma and chronic otorrhea. • Patients who have completed or abandoned this study or any other study with cefaclor or amoxicillin / clavulanate. • History of significant kidney damage. • Any condition, including significant underlying disease or concomitant infection that in the opinion of the investigator, excludes the patient from response evaluation: chronic diarrhea, irritable bowel syndrome, or malabsorption syndromes. Diarrhea is defined as an increase in the frequency of fluid stools compared to the child´s usual pattern. • Anticipated requirement for the use of systemic antibiotics other than the study antibiotic after the pre-therapeutic evaluation and before the post-therapeutic evaluation. • Patient´s inability to resume follow-up visits. • Hypersensitivity to cephalosporins or penicillins. • Spontaneous perforation of the tympanic membrane and drainage for more than 72 hours in the pre-therapeutic evaluation. • Patients with tympanostomy tubes. • Signs or symptoms of meningitis or mastoiditis. • Women who have reached menarche.
Design outcomes
Primary
| 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. | — |
Secondary
| 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 | — |
Outcome results
None listed