None listed
Conditions
Interventions
SB-275833 Type of group
SB-275833 1% topical 2 times a day for 5 days
Group name:Cefalexin Type of group
Cefalexin 500mg in adults, or 12.5mg/kg in children, twice daily for 10 days
Sponsors
GLAXOSMITHKLINE BIOLOGICALS,
Eligibility
Inclusion criteria
Inclusion criteria: • The subject is> 13 years old • The subject and / or his / her legal parent (s) / guardian (s) have given written informed consent dated to participate in the study. • The subject has a diagnosis of atopic dermatitis, psoriasis or allergic contact dermatitis. • The subject has one or more of the following clinical signs and symptoms of secondary infection: a sudden exacerbation of the underlying dermatosis, crusting, secretion, small superficial pustules, or purulent discharge. • Subject has a secondarily infected dermatosis, which is appropriate for treatment with oral or topical antibacterial therapy. • Infected lesions / lesions have <100 cm of area, or up to 2% of body body area in subjects <18 years of age. • The subject has a score on the Scale to Qualify Skin Infection Rating (Scale) of at least 8. • The subject has had a urine test to diagnose the negative pregnancy before recruitment (if it has potential to have a family). • The subject wants and is able to comply with the study protocol.
Exclusion criteria
Exclusion criteria: • The subject has shown prior hypersensitivity to penicillins, cephalosporins, or other p-lactam antibiotics, or the subject has demonstrated a prior hypersensitivity reaction to pleuromutilin or any component of the ointment • The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent. • The subject has systemic signs and symptoms of infection (such as fever, defined as an oral temperature greater than 101 ° F or 38.3 ° C). • The subject requires a surgical intervention, such as incision and drainage, to treat the infection prior to enrolling in the study, or is likely to require such intervention during the course of the study. • The subject has received one or more days of treatment with a systemic or topical antibacterial agent within 72 hours of entering the study. • The subject is receiving systemic corticosteroids at a dose> 10 mg per day of prednisone (or its equivalent). • The subject is concomitantly receiving inhibitors of renal tubular secretion (eg, probenecid). • The subject has a serious underlying disease that could be imminently potentially lethal. • The subject is pregnant, breastfeeding or planning to become pregnant during the study, or has the potential to have a family or is less than one year after menopause and is not using an accepted method of contraception (eg, surgical sterilization, contraceptive device) intrauterine, oral contraception plus barrier contraception, other hormone delivery systems plus barrier contraception, diaphragm or condom in combination with a contraceptive cream, gel or foam) • The subject has used some research drug for 30 days before entering the study. • The subject has been previously enrolled in the present study or in another study involving SB-275833.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of signs and symptoms Measure:Clinical response in the follow-up Timepoints:7 to 9 days after the therapy; days 12 to 14 for SB-275833 in 1% ointment and days 17 to 19 for cephalexin | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of signs and symptoms Measure:Clinical response at the end of therapy Timepoints:2 to 4 days after treatment, days 7-9 and 12-14 ; Outcome name:Clinical evaluation of signs and symptoms Measure:Clinical response on days 7-9 Timepoints:end of topical therapy, in oral therapy ; Outcome name:Clinical evaluation of signs and symtoms Measure:Clinical response on days 12-14 Timepoints:follow-up of topical therapy, end of oral therapy ; Outcome name:Final follow-up of topical therapy, follow-up of oral therapy Measure:Clinical response on days 17-19 Timepoints:days 17-19 ; Outcome name:2-4 days after treatment, days 7-9 for topical therapy and days 12-14 for oral therapy Measure:Microbiological response at the end of therapy Timepoints:2-4 days after treatment, days 7-9 for topical therapy and days 12-14 for oral therapy ; Outcome name:Microbiological response at follow-up (7-9 days after therapy, days 12-14 for topical therapy and days 17-19 for oral therapy) Measure:Microbiological response at follow-up Timepoints:7-9 days after therapy, days 12-14 for topical therapy and days 17-19 for oral therapy ; Outcome name:Microbiological response on days 7-9 (end of topical therapy, in oral therapy) Measure:Microbiological response on days 7-9 Timepoints:days 7-9 ; Outcome name:Microbiological response on days 12-14 (follow-up of topical therapy, end of oral therapy) Measure:Microbiological response on days 12-14 Timepoints:days 12-14 ; Outcome name:Microbiological response on days 17-19 (final follow-up of topical therapy, follow-up of oral therapy) Measure:Microbiological response on days 17-19 Timepoints:days 17-19 | — |
Countries
Austria, Italy
Outcome results
None listed