Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
Condition: Staphylococcal Infection
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections; Soft Tissue Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight
      bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care
      for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in
      children and adults. The study will occur in areas where community associated
      methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria.
      A total of 1310 volunteers, greater than or equal to 6 months of age and adults 85 years or
      younger, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be
      enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX,
      or placebo (contains no medication). Volunteers will be grouped based on the presence of
      cellulitis or abscess, whether the abscess can be surgically drained, and its size. The
      subject participation duration for this study is about 6 weeks.
    

Detailed description: 
      Clinical practice in the treatment of community-onset skin and soft tissue infections (SSTI)
      has not kept pace with the emergence of methicillin-resistant Staphylococcus aureus (MRSA) in
      the community. This clinical trial will evaluate clindamycin (CLINDA) and
      trimethoprim-sulfamethoxazole (TMP-SMX) and wound care for the outpatient management of
      uncomplicated skin and soft tissue infection (uSSTI) in 3 metropolitan areas, Chicago, Los
      Angeles, and San Francisco, cities with high prevalence of community acquired (CA)-MRSA. This
      is a phase IIb multicenter, stratified, randomized, double-blind trial in which enrolled
      subjects with abscess or cellulitis will be treated with CLINDA, TMP-SMX, or placebo.
      Participants will include 1310 non-immunocompromised out-patients age 6 months to 85 years
      with SSTIs not requiring hospital admission. Subjects will undergo a screening/baseline
      evaluation, including determination of presence and size of abscess and/or presence of
      cellulitis. Subjects will then be randomized to receive treatment with either CLINDA,
      TMP-SMX, or placebo depending on whether they have: a larger drainable abscess, defined as
      greater than 5 cm in diameter in adults and as greater than 3 cm in diameter for ages 6-11
      months, greater than 4 cm for ages 1-8 years, and greater than 5 cm for age 9 years and
      older; a limited drainable abscess, defined as less than or equal to 5 cm for adults and as
      less than or equal to 3 cm for ages 6-11 months, less than or equal to 4 cm for ages 1-8
      years, and less than or equal to 5 cm for age 9 years and older; or cellulitis or erysipelas
      only. If the diameter of the abscess greater than 5 cm (smaller for children depending on
      age) or 2 or more sites of skin infection are present the subject will be randomized (1:1) to
      10 days of therapy with TMP-SMX or CLINDA. If the diameter of the abscess less than or equal
      to 5 cm (smaller for children depending on age) then the subject will be randomized (1:1:1)
      to TMP-SMX, CLINDA or placebo for 10 days. Subjects with cellulitis or erysipelas only will
      be randomized (1:1) to TMP-SMX or CLINDA for 10 days. Subjects will be provided study drug,
      instructed in its use, and scheduled for 4 follow-up visits including: wound check (24-48
      hours after enrollment); end of therapy (48 hours after completion of therapy); test of cure
      (7-10 days after completion of therapy); and a final visit at one month after completion of
      therapy. The primary objectives of this study are: to compare the cure rate of CLINDA to that
      of TMP-SMX for the treatment of patients with cellulitis or larger abscess at the Test of
      Cure (TOC) visit and to compare the cure rate of CLINDA, TMP-SMX, and placebo, each in
      conjunction with surgical drainage for the treatment of subjects with limited abscess at the
      TOC visit.
    

Intervention name(s): Trimethoprim-sulfamethoxazole; Placebo; Clindamycin
Intervention type(s): Drug; Other; Drug
Intervention description(s): Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child > 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child < 40 kg dose). Study drug will be administered for 10 days.; Placebo capsules will be identical in appearance to the CLINDA and TMP-SMX. Administered 3 times daily for 10 days.; CLINDA (adult dose of 300 mg three times daily; pediatric dose of 25-30 mg/kg/day divided three times daily up to a maximum dose of 900 mg/day). Study drug will be administered for 10 days.
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methicillin-resistant Staphylococcus aureus (MRSA), cellulitis, abscess, children, elderly