Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
Condition: Skin Infections, Bacterial
MeSH terms: Cellulitis; Skin Diseases, Infectious; Bacterial Infections; Impetigo
Intervention: Retpamulin Ointment, 1%; Linezolid
Intervention description: Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days.; Adult and adolescent (=>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects <5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days.
Intervention MeSH terms: Linezolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 410.0
Sex: All
Minimum age: 2 Months
Healthy volunteers: No
Keywords: impetigo; methicillin-resistant Staphylococcus aureus; linezolid; secondarily-infected traumatic lesion; uncomplicated skin infection; retapamulin

Summary:

      The purpose of this study is to provide further evidence of the clinical and bacteriological
      efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA.
      Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days
      or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up
      (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The
      primary population is the per-protocol MRSA population. It is anticipated that approximately
      500 subjects may be enrolled in order to obtain approximately 105 subjects who have a
      baseline MRSA infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2 months of age or older

          -  diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous or
             non-bullous)

          -  negative urine pregnancy test (females of childbearing potential)

          -  total skin infection rating scale (SIRS) score of at least 8, which must include a
             pus/exudate score of at least 3

          -  subject or parent/legal guardian willing and able to comply with protocol

          -  written informed, dated consent, and written assent (if applicable)

        Exclusion Criteria:

          -  previous hypersensitivity to pleuromutilins or oxazolidinones

          -  phenylketonuria or known hypersensitivity to aspartame

          -  secondarily-infected animal/human bite, or puncture wound

          -  abscess

          -  chronic ulcerative lesion

          -  underlying skin disease (eg, eczematous dermatitis) with secondary infection

          -  systemic signs and symptoms of infection

          -  skin infection not appropriate for treatment by a topical antibiotic (eg, extensive
             cellulitis, furunculosis)

          -  subject requires surgical intervention for infection prior to study or likely will
             during the study

          -  receipt of systemic antibacterial or steroid, or application of any topical
             therapeutic agent directly to wound within 24 hours of entry into the study

          -  subject currently receiving adrenergic agents

          -  subject currently receiving serotonergic agents

          -  history of pseudomembranous colitis

          -  known, pre-existing myelosuppression, history of myelosuppression with linezolid use,
             or receiving a medication that produces bone marrow suppression

          -  history of siezures

          -  history of severe renal failure and undergoing dialysis

          -  serious underlying disease that could be imminently life-threatening

          -  pregnant, breast feeding or planning a pregnancy, or not using accepted method of
             contraception (females of childbearing potential or <1 year post-menopausal)

          -  use of another investigational drug within 30 days prior to entry into this study

          -  previously enrolled in this study

          -  fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase
             insufficiency (for subjects <12 years of age receiving linezolid suspension)