Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections

Not Applicable

• Conditions: -H669 Otitis media, unspecified; Otitis media, unspecified; H669

• Registration Number: PER-027-05
• Lead Sponsor: AVENTIS PHARMA S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation<br>Measure:Efficacy of treatment<br>Timepoints:Days 13-17<br>