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

ELI LILLY INTERAMERICA INC.,0 个研究点目标入组 0 人开始时间: 2000年2月3日最近更新: 2023年9月4日

适应症

试验速览

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•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.

•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.

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