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Table 2 Schedule of events

From: Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial

 

Induction period

Screening/enrollment

Open label treatment period

Post-treatment follow-up period

Visit 0 (pre-screening, day −10 to day 1)

Visit 1 (day −1 to day 1)

Visit 2 (baseline, day 1)

Visit 3 (day 8 ± 1 day)

Visit 4 (day 22 ± 2 days)

Visit 5 (day 42 ± 3 days)

Visit 6 (TOC, day 70 ± 7 days)a

ETb

Visit 7 (day 180 ± 14 days, osteomyelitis group)a

Informed consent

 

X

       

Dalbavancin administrationc

  

X

X

     

Standard of care antibiotic therapyc

X

X

X (Duration 28–56 days)

   

Medical historyd

 

X

X

  

X

X

X

 

Medication historye

 

X

       

Randomization

  

X

      

AEs/AESIs/SAEs

  

X

X

X

X

X

X

 

Hematology and serum chemistry blood samplingf

 

X

 

Xg

X

X

   

Coagulation lab testsf

 

X

       

Pregnancy testh

 

X

       

PK samplingi

  

X

X

X

X

X

X

 

Vital signsj

 

X

X

Xk

X

X

X

X

X

Physical examinationl

 

X

X

X

X

X

X

X

X

Echocardiogramm

 

X

       

Investigator assessment of efficacy

     

X

X

X

X

Concomitant medicationsn

 

X

X

X

X

X

X

X

X

Concomitant nondrug interventions

 

X

X

X

X

X

X

X

X

QoL assessmento

  

X

X

X

X

X

X

X

  1. AEs, adverse events; AESIs, adverse events of special interest; eCRF, electronic case report form; ET, early termination; PK, pharmacokinetic; SAE, serious adverse events; TOC, test of cure; QoL, quality of life
  2. aTelephone visit permissible if in-person visit is not possible; in person visit still preferred
  3. bPatients who prematurely discontinue therapy should have an ET Visit within 72 h
  4. cAll subjects will be receiving standard of care prior to randomization; after randomization, subjects will receive either dalbavancin or standard of care based on their assigned treatment group
  5. dIncludes targeted/pertinent medical and surgical history only
  6. eA complete medication history will be completed through 30 days prior to ICF signing; an extended 60-day review will be conducted for dalbavancin and oritavancin given the long half-lives of both drugs
  7. fVisit 1 hematology, coagulation lab tests (PT, PTT, and/or INR), and serum chemistry will be done in order to qualify the patient for the study, if not already collected per standard of care within 48 hours prior to randomization
  8. gA serum creatinine assessment will be required within the 72 h prior to the 2nd (day 8) dalbavancin dose. Whether a serum creatinine must be repeated on day 8 will be at the discretion of the site investigator based upon stability of the serum creatinine in the preceding 72 h and whether the serum creatinine is near the threshold where dose adjustment would be necessary (e.g., near 30 mL/min)
  9. hWomen of childbearing potential only, if not already performed; ensure test is negative within 48 h before randomization. If the serum test results cannot be obtained before randomization, a urine pregnancy test may be used for enrollment
  10. iDalbavancin PK samples will be drawn only for subjects receiving dalbavancin. PK samples will be drawn at day 1 prior to dose, at end of infusion ± 10 min, 6 ± 2 h post end of dose, 12 ± 4 h post end of dose, 24 ± 6 h post end of dose), day 8 (prior to 2nd dose), day 22 ± 2 days (at time of clinic visit), day 42 ± 3 days, day 70 ± 7 days, and with any ET visit. Each sample must be accompanied by draw time and date
  11. jVital signs include blood pressure, respiration rate, pulse rate, and temperature
  12. kDay 8 vital signs not required for subjects receiving SOC antibiotics if discharge occurs prior to day 8
  13. lA physical examination (including general appearance, examination of head, eyes, ears, nose, throat, neck, skin, heart, lungs, abdomen, neurologic system, musculoskeletal system, extremities, height, and body weight) will be done at Screening (visit 1). If height or weight is not obtainable (e.g., patient is immobilized), use the last known or stated height and weight. At subsequent visits, targeted physical exams will focus on changes from prior exams and on the evaluation of newly reported symptoms
  14. mTransthoracic echocardiogram or, if clinically indicated, transesophageal echocardiogram to be performed (local laboratory), unless one has been performed as standard of care for this episode of bacteremia/endocarditis
  15. nAll concomitant medications from screening (visit 1) through day 42 (± 3 days) (visit 5) must be recorded in the patient’s medical record and on the eCRFs. Between the day 42 visit and day 70 visit, all concomitant medications for an AE or any antibacterial therapy should be recorded in the patient’s medical record and on the eCRF
  16. oQoL assessments include the ARLG Bloodstream Infection QoL Measure, the EQ-5D-5L (https://euroqol.org/eq-5d-instruments/sample-demo/), and the PROMIS Global Health Short Form (http://www.healthmeasures.net/administrator/components/com_instruments/uploads/Global%20Health%20Scale%20v1.2%2008.22.2016.pdf)
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