Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
Condition: Skin Infections, Bacterial
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Bacterial Infections
Intervention: Retapamulin Ointment, 1%
Intervention description: 1% Ointment
Intervention MeSH terms: Retapamulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 2 Months
Maximum age: 24 Months
Healthy volunteers: No
Keywords: SID; impetigo; pharmacokinetics; Retapamulin ointment, 1%; Skin abnormalities; Dermatoses; pediatric; infection; SITL

Summary:

      A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects
      (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses,
      or impetigo (bullous and non-bullous).
    

Eligibility criteria:

        Inclusion criteria:

          -  Subject Age: The subject is ≥2 months to ≤24 months of age at study entry

          -  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:

        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.

        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.

          -  Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin
             Infection Rating Scale)

          -  Protocol Compliance: The parent/legal guardian is willing to comply with the protocol

          -  Informed Consent: The parent/legal guardian has given written informed, dated consent
             for the subject to participate in the study

          -  French Subjects: In France, a subject will be eligible for inclusion in this study if
             either affiliated to or a beneficiary of a social security category

        Exclusion criteria:

          -  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%)

          -  The subject was considered to be premature at birth (<37 weeks gestation)

          -  The subject has a secondarily-infected animal/human bite, or a puncture wound

          -  The subject has an abscess

          -  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 a
             temperature equivalent to a rectal temperature greater than 101°F or 38.3°C)

          -  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

          -  The subject has more than one type of infected lesion as defined in the protocol

          -  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

          -  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

          -  The subject has received one or more days of treatment with a systemic antibacterial
             within 72 hours of study entry

          -  The subject is receiving systemic corticosteroids at a dose of >0.125mg/kg per day of
             prednisone (or the equivalent)

          -  The subject has a known, pre-existing, serious underlying disease that could be
             imminently life-threatening

          -  The subject has participated in any study using an investigational drug during the
             previous 30 days prior to entering the study

          -  The subject has been previously enrolled in this study or in any other study involving
             Retapamulin