CEFACLOR BID VERSUS AMOXICILLINE / BID CLAVULANATE IN THE TREATMENT OF CHILDREN WITH ACUTE MEDIUM OTITIS WITH EFUSIO

Not Applicable

• Conditions: -H65; H65

• Registration Number: PER-054-00
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-10-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Patients must be diagnosed with acute otitis media 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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>Improvement: Significant but incomplete resolution of signs and symptoms of infection, in relation to the initial examination.<br>Failure: Signs and symptoms do not diminish or improve with treatment.<br>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.<br>Indeterminate: Inability to evaluate a symptomatic response.<br>Measure:Efficacy<br>Timepoints:It will be evaluated in the post-therapeutic and late post-therapeutic period.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:The safety evaluation will be performed recording adverse events at the time of visits.<br>Measure:Safety<br>Timepoints:During all of the visits<br>