None listed
Conditions
Interventions
Group 1 Type of group
SB-275833 will typically be applied at an average dose between 2 to 5 mg / cm2 once a day for 7 days
Group name:Group 2 Type of group
Apply the placebo in ointment once a day for 7 days
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient is> 9 months of age. 2. The patient has a clinical diagnosis of primary impetigo 3. The patient has no more than 10 lesions 4. The infected lesion (s) must not exceed 100 cm in area 5. Female patients with potential to have family who have had a negative result in a urine test to diagnose pregnancy. 6. The patient has a score on the Skin Infection Rating Scale in at least 8 7. The patient is willing and able to comply with the study protocol. 8. The patient has given his informed consent FOR CHILDREN UNDER 18 YEARS OF AGE 9. The parent / legal guardian is willing to comply with the protocol. 10. The child has given his / her assent to participate in the study. 11. The parent / legal guardian has given informed consent
Exclusion criteria
Exclusion criteria: 1. The patient has demonstrated a prior hypersensitivity reaction to pleuromutilin or any component of the ointment. 2. The patient has an underlying skin disease. 3. The patient has signs and symptoms of a systemic infection. 4. The patient has a bacterial infection of the skin; which, due to its depth or severity, can not be treated properly with a topical antibiotic. 5. The patient has received an antibacterial or a systemic steroid, or a topical therapeutic agent has been applied less than 24 hours before entering the study. 6. The patient has a serious underlying disease, which could be immediately potentially lethal. 7. The patient is pregnant, breastfeeding or planning to become pregnant during the study. 8. The patient has used a drug under investigation during the 30 days prior to entering the study. 9. The patient has been previously enrolled in the present study or in any other study involving SB-275833.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Improvement of injuries Measure:Efficiency of SB-275833 Timepoints:7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Follow-up clinical evaluation Injury crops Measure:Clinical response during follow-up. Percentage of patients who had positive cultures for methicillin-resistant S. aureus (MRSA) at the beginning and end of therapy Timepoints:Clinical evaluation was monitored: days 9 and 14. Injury crops: Day 1, Day 7 and Day 14 | — |
Countries
Argentina, Canada, Costa Rica, France, Germany, India, Italy, Mexico, Netherlands, Peru, Poland, South Africa
Outcome results
None listed