An Open-Label Study to Demonstrate Bacteriologic Efficacy Augmentin ES inthe Treatment of AOM Due to S. pneiimoniae: Revised PRSP Report

Not Applicable

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

• Registration Number: PER-012-02
• Lead Sponsor: GLAXO WELCOME S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-01-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• From 6 to 30 months of age.
• The patient´s parents or legal guardians can comply with the protocol.
• The patient has acute otitis media, diagnosed based on otoscopic findings.

Exclusion Criteria

• Weight greater than 40 kg.
• Spontaneous drilling of TM with secretion of more than 24 hours.
• Patients with bilateral or infected ear tubes who are being followed for bacteriological and clinical evaluation, or who have anatomical alterations that are accompanied by prolonged SME

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Bacteriological response (bacteriological success or failure) in patients with otitis media caused by S. pneumoniae with MIC for penicillin> = 2 mcg / mL during the visit during therapy (days 4-6) and bacteriological response (bacteriological success or failure ) in patients with acute otitis media caused by S. pneumoniae with MIC for amoxicillin / clavulanic acid = 4 mcg / mL during the visit during therapy (days 4-6).<br>Measure:Clinical efficacy at the end of the treatment visit (Day 12-14) of Augmentin ES-600 (90 / 6.4mg / kg / day in divided doses every 12 hours for 10 days) vs that of Zithromax (10mg / kg in a single dose) on Day 1 followed by 5mg / kg / day every 24 h on Days 2 to 5) in younger and older infants with AOM caused by any of the four pathogens defined in the protocol.<br>Timepoints:days 4-6<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Respuesta bacteriologica (exito o fracaso bacteriologico) de otros/multiples patogenos a la medicacion en estudio en la visita durante la terapia (dias 4- 6); y presumible respuesta bacteriologica de otros patogenos a la medicacion en estudio en la visita al final del tratamiento (dias 12-15).<br>Respuesta clinica (exito o fracaso bacteriologico) en la visita al final del tratamiento (dias 12-15); y respuesta clinica (exito o fracaso clinico) en la visita para evaluar la curacion (dias 25-28).<br>Measure:To compare the bacteriological efficacy (known) in the visit in treatment (Day 4-6) of Augmentin ES-60O vs that of Zithromax in the eradication of all pathogens defined in the protocol (S. pneumoniae, H. influenzae, M. catarrhalis and / or S. pyogenes) of the middle ear fluid (LOM) of younger and older infants with AOM.<br>Timepoints:days 4-6<br>