ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

GlaxoSmithKline3,612 enrolled

Overview

This is an open label, multi-centre, non-interventional post-marketing surveillance.

This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ALTARGO(retapamulin) treated in Korean patients according to the prescribing information. ALTARGO is a trademark of the GlaxoSmithKline group of companies.

Study Type

OBSERVATIONAL

Enrollment

3,612

Conditions

Skin Infections, Bacterial

Interventions

ALTARGO(retapamulin)DRUG

Basically there is no treatment allocation. Subjects who would be administered of ALTARGO(retapamulin) at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Eligibility

Sex: ALLMin age: 9 Months

Medical Language ↔ Plain English

Inclusion Criteria: * All subjects must satisfy the following criteria at study entry: 1. Subjects administered with ALTARGO(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (SSSI) 2. Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen 3. Subjects administered with ALTARGO(retapamulin) following the locally approved prescribing information Exclusion Criteria: * Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with retapamulin following the locally approved Prescribing Information. 1. Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or any component of the ointment 2. Infants under nine months of age

Locations (1)

GSK Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

The number of adverse event after ALTARGO(retapamulin) treatment

Time frame: 14 days

Secondary Outcomes

The number of unexpected adverse event after ALTARGO(retapamulin) treatment

Time frame: 14 days

The number of serious adverse event after ALTARGO(retapamulin) treatment

Time frame: 14 days

Effectiveness of ALTARGO(retapamulin) treatment

Time frame: 7 days

Data from ClinicalTrials.gov

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