Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)

GlaxoSmithKline363 enrolled

Overview

This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media. ("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)

Study Type

OBSERVATIONAL

Enrollment

363

Conditions

Otitis Maedia

Interventions

Amoxicillin and clavulanateDRUG

Eligibility

Sex: ALLMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis Exclusion Criteria: * Not applicable

Outcomes

Primary Outcomes

The number of incidence of adverse events in Japanese pediatric patients, with diseases other than otitis media, treated with amoxicillin and clavulanate based on prescribing information

Time frame: 2 months

Clinical symptoms after treatment with amoxicillin and clavulanate

Time frame: 2 months

Data from ClinicalTrials.gov

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