Uncomplicated skin and skin structure infections
Conditions
Interventions
Trade Name: Altargo
Product Name: Retapamulin
Product Code: SB275833
Pharmaceutical Form: Ointment
INN or Proposed INN: Retapamulin
CAS Number: 224452-66-8
Current Sponsor code: SB-275833
Other descri
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject Age: The subject is =2 months to =24 months of age at study entry. 2. Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy: SITL: The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion. SID: The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area. Impetigo: The subject has a lesion or group of ?10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin. 3. Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin Infection Rating Scale) 4. Protocol Compliance: The parent/legal guardian is willing to comply with the protocol. 5. Informed Consent: The parent/legal guardian has given written informed, dated consent for the subject to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous Hypersensitivity: The subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of Retapamulin ointment, 1%). 2. Prematurity: The subject was considered to be premature at birth (0.125mg/kg per day of prednisone (or the equivalent). 13. Serious Underlying Disease: The subject has a known, pre-existing, serious underlying disease that could be imminently life-threatening. 14. Other Investigational Drug: The subject has participated in any study using an investigational drug during the previous 30 days prior to entering the study. 15. Other Retapamulin Studies: The subject has been previously enrolled in this study or in any other study involving Retapamulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the systemic exposure, by using pharmacokinetic (PK) sampling at four to eight hours post-dose, of Retapamulin Ointment, 1%, when applied topically, twice daily for five days, in the treatment of pediatric subjects aged =2 to =6 months, >6 to =12 months, and >12 to =24 months with uncomplicated skin and skin structure infections, including secondarily-infected traumatic lesions (SITL), secondarily-infected dermatoses (SID) and impetigo.;Secondary Objective: • To summarize the safety and tolerability of Retapamulin Ointment, 1% in the treatment of pediatric subjects aged =2 to =6 months, >6 to =12 months, and >12 to =24 months with uncomplicated skin and skin structure infections, including secondarily-infected traumatic lesions (SITL), secondarily-infected dermatoses (SID) and impetigo • To summarize the clinical and bacteriological efficacy of Retapamulin Ointment, 1%, in the treatment of pediatric subjects aged =2 to =6 months, >6 to =12 months, and >12 to =24 months with uncomplicated skin and skin structure infections, including secondarily-infected traumatic lesions (SITL), secondarily-infected dermatoses (SID) and impetigo ;Primary end point(s): PK endpoint: Plasma concentrations of retapamulin at anytime during the window of 4 to 8 hours post-dose of the first dose on Visit 2 (day 3 or day 4) will be descriptively summarized by this pre-specified time window and by age groups (=2 to =6 months, >6 to =12 months, and >12 to =24 months), if data permit. Safety endpoint: Collection of safety data (including incidence of AEs and abnormal lab values). Efficacy endpoints • Clinical response at Follow-up (Day 12-16) • Bacteriological response at Follow-up (Day 12-16) • Therapeutic response (combined clinical and bacteriological responses) at follow-up (Day 12-16) | — |
Countries
Germany, Netherlands
Outcome results
None listed