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Table 3 Schedule of study visits

From: Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis—the PMEP trial: study protocol for a randomized controlled trial

 

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

  1. aSpontaneous expectorated sputum collected 5 ± 4 minutes after nebulizing study drug. Gargle with 30 cc of saline for ten seconds x3 prior to collection.
  2. bPeak drawn 60 ± 10 minutes after end of nebulization on day 1; trough drawn with other blood tests prior to nebulization on day 14.
  3. cSerum pregnancy test done at screening, urine at other time points.
  4. dWash with water and one packet of Hibiclens hand cleanser for 2 minutes. Skin reaction will be observed for 15 minutes after washing.
  5. eRandomization will be a non-visit task on Day −4 (±3 days) once culture results from run-in visit confirm presence of MRSA.
  6. fCFU’s will be done if early withdrawal visit occurs between visit 2 and visit 4.
  7. gIf applicable, only if early withdrawal visit occurs between visit 1 and visit 4.
  8. hIf applicable, only if early withdrawal visit occurs before visit 3.
  9. iHistory of previous treatment for MRSA, number of MRSA cultures, and length of MRSA positivity at screening visit.
  10. gContinuous pulse oximetry is performed during nebulization of study drug and for 5 minutes afterward on Days 1, Repeat admin visit and Day 14. Observe for 1 h post-treatment.
  11. kOn days CFQ-R is performed, it is done before any other interventions.
  12. lTwo puffs of Albuterol HFA 10–30 minutes prior to spirometry and 10–60 minutes prior to study drug nebulization on Days 1 and 14.
  13. mSingle spirometry value also obtained immediately after and 15 minutes after study drug nebulization on Day 1 and Repeat Administration Day.
  14. nFollow TDN Sputum Induction protocol 517.01; throat swab if inadequate sputum produced.
  15. oOnly if culture grows MRSA.
  16. pFollow TDN Sputum Processing Protocol 508.01.
  17. qRectal swabs optional and only age ≥18; no rectal swab on day 58.