None listed
Conditions
Interventions
Group 1 Type of group
All patients in this group will receive SB-275833 in 1% topical ointment twice a day for 5 days. The amount of agent applied will depend on the size of the infected lesions. Based on a maximum lesion size of 100 cm2, the maximum amount of SB-275833 in ointment formulation applied per dose to a subject would be 2 to 5 mg per cm2. The total daily dose of the ointment applied would be 0.4 to 1 gram per 100 cm, which would contain 4 to 10 mg of the substance of the drug SB-275833.
Group name:Grou
All patients in this group will receive the placebo in ointment 2 times a day for 5 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 does not have 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 written and dated informed consent to participate in the study. For pediatric patients below the legal age for consent: 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.
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, 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. 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 Measure:Eficacia del SB-275833 en ungüento al 1% Timepoints:7th day of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Clinical Final Events: Clinical Evaluation 2) Microbiological Final Events: Injury cultures Measure:1) Clinical Final Events: Clinical response in the follow-up. Evaluation of the area of the lesions at the end of the therapy. 2) Microbiological Final Events: Microbiological response at the end of the treatment. Microbiological response during follow-up. Number and percentage of patients in whom methicillin-resistant Staphylococcus aureus was isolated at the beginning, end of treatment and during follow-up Timepoints:1) Clinical Final Events: Days 7 and 14 2) Microbiological end events: Microbiological response on Day 7. Microbiological response on Day 14. Number and percentage of patients in whom methicillin-resistant Staphylococcus aureus was isolated. (Day1), at the end of therapy on Day 7, after treatment and on Day 14 at follow-up | — |
Countries
India, Mexico, Netherlands, Peru
Outcome results
None listed