None listed
Conditions
Interventions
Augmentin ES-600 (90 / 6.4mg / kg / day in divided doses every 12 h) for 10 days together with some food.
Group name:GROUP II Type of group
Zithromax (lOmg / kg in single dose on Day 1 followed by 5mg / kg / day q24h from Day 2 to 5) for 5 days without food (ie, at least one hour before feeding or at least two hours after feeding) .
Sponsors
GLAXO WELCOME S.A.,
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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. Timepoints:days 4-6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). 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). 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. Timepoints:days 4-6 | — |
Countries
Peru, United States
Outcome results
None listed