PER-027-05Completed未知
COMPARATIVE, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, DOUBLE SIMULATED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TELITROMYCIN 25MG / KG SUPPLIED ONCE A DAY FOR 5 OR 10 DAYS DEPENDING ON THE AGE AND HISTORY OF PREVIOUS TREATMENTS VERSUS CEFUROXIMA AXETIL 15 MG / KG SUPPLIED TWICE A DAY FOR 10 DAYS, IN CHILDREN WITH ACUTE MEDIUM OTITIS.
AVENTIS PHARMA S.A.,0 sites0 target enrollmentStarted: June 22, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 0 (—)
Inclusion Criteria
- •1) Subjects greater than or equal to 6 months and <59 months of age with AOM.
- •2) A sudden and recent attack with signs and symptoms of AOM.
- •3) The presence of LOM in the otoscopy indicated by a protruding tympanic membrane.
- •4) A tympanometry that presents the following results: A type B curve or positive pressure peak curves consistent with the presence of LOM.
- •5) Otalgia or that the patient is pulling or touching the ear in the last 24 hours, that interfere with, or avoid normal activities or sleep.
- •6) At least one of the following non-specific clinical findings for AOM: fever, vomiting, diarrhea, anorexia, sleep disturbances, or irritability.
- •7) Tympanocentesis executed according to the protocol.
- •8) Written informed consent must be obtained at the time of recruitment.
Exclusion Criteria
- •1) An unclear diagnosis of AOM.
- •2) Otorrea or tube of tympanostosmia present in any of the ears upon entering the study.
- •3) Otitis extema.
- •4) Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis / mucoviscidosis, immobile cilia syndrome, congenital imminence or acquired immunodeficiency syndrome with a <25% CD4 count or requiring prophylaxis for Pneumocystis Jiroveci.
- •5) Known congenital prolonged QT syndrome.
- •6) Uncorrected hypokalemia, hypomagnesemia, bradycardia.
- •7) Myasthenia gravis.
- •8) Known impaired renal function.
- •9) Any medical condition that, in the opinion of the investigator, could interfere with the implementation of the protocol or with the interpretation of the results of the study.
- •10) The subject: a) Is being treated with drugs not allowed by the protocol b) Is currently being treated with sistemic antibacterials or has been treated with systemic antibacterials in the 5 days prior to recruitment c) Has been treated with research drugs inside of the previous 30 days. d) Has been treated with rifampicin, phenytoin, carbamazepine, or St. John´s wort in the last 2 weeks.
- •11) History of hypersensitivity or intolerance to macrolides, penicillins or cephalosporins
- •12) Previous recruitment in this study or previous treatment with telithromycin.
- •13) Children of researcher or sub-investigator, research assistant, pharmacist, study coordinator, or other staff members, or relatives of the people involved in the conduct of the protocol
Investigators
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