An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months
- Conditions
- ncomplicated skin and skin structure infections
- Registration Number
- EUCTR2006-003374-10-DE
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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 (<37 weeks gestation).
3.Bite or puncture: The subject has a secondarily-infected animal/human bite, or a puncture wound.
4.Abscess: The subject has an abscess.
5.Unlikely to have S aureus or S pyogenes: The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent.
6.Systemic Infection: The subject has systemic signs and symptoms of infection (such as fever; defined as a temperature equivalent to a rectal temperature greater than 101°F or 38.3°C).
7.Inappropriate for Topical Treatment: The subject has a bacterial skin infection which, due to area, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic.
8.Infected Lesion Type: The subject has more than one type of infected lesion as defined in the protocol.
9.Surgical Intervention: The subject requires surgical intervention for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study.
10.Other Topicals: The subject has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials or antifungals) directly to the infected wound/lesion, within 24 hours prior to study entry.
11.Systemic Antibacterials: The subject has received one or more days of treatment with a systemic antibacterial within 72 hours of study entry.
12.Systemic Corticosteriods: The subject is receiving systemic corticosteroids at a dose of >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method