STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)

Prior treatment

• Received antibiotics with activity against MRSA within 28 days prior to screening
• Use of an investigational agent within 28 days prior to screening
• MRSA from the screening culture or the most recent clinical care visit within 6 months prior to screening resistant to TMP/SMX

Other illness

• History of intolerance to topical chlorhexidine or mupirocin
• History of intolerance to both TMP/SMX and minocycline
• History of solid organ or hematological transplantation
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Lab values

• Subjects with history of abnormal renal function will need screening labs showing normal function Abnormal renal function is defined as estimated creatinine clearance \<50 mL/min using the:
  • Bedside Schwartz Equation for subjects \<18 years of age, and
  • Levey Glomerular filtration rate (GFR) Equation for subjects ≥ 18 years of age.
• Subjects with a history of abnormal liver function will need to have screening labs showing normal transaminases. Liver dysfunction is defined as ≥3x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT) or abnormal synthetic function

Age

• For subjects ≥ 6 years of age: FEV1 at screening \< 25% of predicted for age based on the Wang (males \< 18 years, females \< 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations
• \< 8 years of age and allergic or intolerant to TMP/SMX
• ≥ 8 years of age and allergic or intolerant to TMP/SMX and MRSA isolate (from screening or clinical care visit)is resistant to minocycline

Other

• For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 42 of the study

• Male or female ≥ 2 and ≤ 45 years of age at the Screening Visit.
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
  • sweat chloride ≥ 60 milliequivalents/liter by quantitative pilocarpine iontophoresis test (QPIT)
  • two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
  • abnormal nasal potential difference(NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
• First OR early MRSA colonization defined as:
  • First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening
  • Early MRSA colonization: MRSA was previously isolated from the respiratory tract ≤ 2 times over the past 3.5 years, but this was followed by at least 1 year of documented negative cultures for MRSA
• MRSA is available to the central laboratory - either the incident MRSA isolate from the clinic visit or the subject is MRSA positive at the screening visit
• Clinically stable with no significant changes in health status within the 14 days prior to screening
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study