ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

Study Overview
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Brief Summary
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This is an open label, multi-centre, non-interventional post-marketing surveillance.

Detailed Description
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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.

Official Title
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An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ALTARGO(Retapamulin) Administered in Korean Patients According to the Prescribing Information

Conditions
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Skin Infections, Bacterial

Intervention / Treatment
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* Drug: ALTARGO(retapamulin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must satisfy the following criteria at study entry: Subjects administered with ALTARGO(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (SSSI) Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen 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. Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or any component of the ointment Infants under nine months of age

Ages Eligible for Study
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Minimum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALTARGO(retapamulin)<br>The subjects with bacterial skin and skin structure infections (SSSI) | Drug: ALTARGO(retapamulin)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse event after ALTARGO(retapamulin) treatment |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of unexpected adverse event after ALTARGO(retapamulin) treatment |  | 14 days | 
| The number of serious adverse event after ALTARGO(retapamulin) treatment |  | 14 days | 
| Effectiveness of ALTARGO(retapamulin) treatment |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impetigo, secondarily-infected traumatic lesions, retapamulin