COMPARATIVE STUDY OF CEFACLOR BID VS AMOXICILLIN / IDB CLAVULANATE IN CHILDREN WITH ACUTE MEDIUM OTITIS WITH EFFUSIO

Not Applicable

Completed

• Conditions: -H650 Acute serous otitis media; Acute serous otitis media; H650

• Registration Number: PER-008-00
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02-03
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

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

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

• 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