Screening visit (Day-28) (±2 days) | Run-in visit (Day −14) (±4 days) | Visit 1 (START TREATMENT) (Day 1) | Visit 2 (REPEAT ADMIN) (Day 2–7) | Phone visit 1 (Day 7–14) | Visit (MID-POINT TREATMENT) (Day 14) (±2 days) | Phone visits 2 & 3 (Day 14–21) (Day 21–28) | Visit 4 (END TREATMENT) (Day 29) (±1 day) | Visit 5 1 month monitoring (Day 58) (±4 days) | Visit 6 3 month monitoring (Day 118) (±7 days) | Early withdraw visit | |
---|---|---|---|---|---|---|---|---|---|---|---|
Informed consent | X | ||||||||||
Randomization | X n | ||||||||||
Medical history (a) | X a | X | X | X | X | X | X | X | X | ||
Demographics | X | ||||||||||
Complete physical exam | X | X | X | X | |||||||
Abbreviated physical exam | X | X | X | X | X | ||||||
Height, weight | X | X | X | X | X | X | X | X | X | ||
Vital signs, oximetry (b) | X | X | X b | X b | X b | X | X | X | X | ||
CFQ-R (c) | X | X | X | X | X | X | |||||
Administer albuterol (d) | X | X | X | X | X | X | X | X | X | ||
Spirometry (e) | X | X | X e | X e | X | X | X | X | X | ||
Sputum induction procedure (f) | X | X | X | X | X | X | X | ||||
Sputum culture and sensitivity | X | X | X | X | X | X | X | ||||
Sputum MRSA colony forming units (g) | X | X | X | X | X | X o | |||||
Small colony variants of MRSA (g) | X | X | X | X | X | X | X | ||||
MRSA: comprehensive genetic strain analysis (g) | X | X | X | X | X | X | X | ||||
Sputum cell count (h) | X | X | X | X | |||||||
Sputum cytokine measurements (h) | X | X | |||||||||
Nasal, axillary, rectal swabs for culture (i) | X i | X i | X i | ||||||||
Administration of study drug | X b | X b | X b | ||||||||
Expectorated sputum vancomycin level (j) | X | ||||||||||
Serum vancomycin levels (k) | X k | X k | X q | ||||||||
Chemistry/LFTs/hematology/CRP | X | X | X | X | X | X p | |||||
Pregnancy test (Urine or Serum) (l) | X l | X l | X l | ||||||||
Initiate subject diary | X | ||||||||||
Subject diary review | X | X | X | X | X | X | X | X p | |||
Concomitant medication review | X | X | X | X | X | X | X | X | X | X | X |
Adverse experiences review | X | X | X | X | X | X | X | X | X | X | |
Hibiclens test hand washing (m) | X | ||||||||||
Provide snack | X | X | |||||||||
Administration of rifampin, protocol determined oral antibiotic, nasal mupirocin and Hibiclens | X | X | |||||||||
Dispense supply of study drug, nebulizer, rifampin, protocol determined oral antibiotic, mupirocin and Hibiclens and provide teaching | X | X | |||||||||
Collect used and unused study drug and containers | X | X | X p |