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Table 1 Schedule of study assessments for the NeoVanc clinical trial

From: An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial

 

Visit 1a

Screening and randomisation visit

Visit 1b

Treatment initiation visit

Visit 2

Renal function measurement visit

Visit 3

Early on treatment visit

Visit 4 a

Day 5 ± 1/

End of Allocated Therapy (optimised arm)

Visit 5

End of allocated Therapy (standard arm) visit

EVT b

Visit 6

Test of Cure visit

Visit 7

Short-term follow-up visit

Visit 8

Audiology follow-up visit

Timing

Day 0

Maximum of 24 h after randomisation

Between Visit 1b and Visit 3

72 ± 8 h after initiation of study vancomycin

5 ± 1 days from initiation of study vancomycin a

10 ± 2 days from initiation of study vancomycin

End of primary course of vancomycin b

10 ± 1 days after end of study vancomycin

30 ± 5 days from initiation of study vancomycin

Up to Day 90 from initiation of study vancomycin

Signed informed consent

X

         

Medical history

X

         

Adverse event reporting

 

X

X

X

X

X

X

X

X

X

Clinical examination

X

  

X

X

X

X

X

X

 

Full blood count

X

(X c)

 

X

X

X

X

  

Renal function measurements

X

(X c)

X

X

X

X

X

X

 

Glucose/Lactate/Base excess

X

(X c)

 

X

X

X

X

  

CRP

X

(X c)

 

X

X

X

X

  

Biomarker sampling

X

(X c)

 

X

X

X

X

 

X

 

Blood culture

X d

(X c)

 

(X)

(X)

     

Blood for bacterial DNA analysis (babies ≥ 29 weeks PMA only)

X

(X c)

 

X

    

X

 

PK sampling and plasma storage e

          

Stool/rectal swab and colonisation swab collection

X

(X c)

  

X f

X

X

 

X

 

Vancomycin administration

 

X

X

X

X

X

X

   

Assessment for relapse/new infection

       

X

X

 

Auditory screening

         

X

  1. X Fixed time; To be repeated if abnormal at EVT; if laboratory results are not available, the closest values existing after EVT will be considered
  2. a All participants except those who have already undergone an EVT visit
  3. b Only participants whose vancomycin has been stopped earlier or later than outlined in the protocol
  4. c If not done at Visit 1a
  5. d If a blood culture has been taken and is positive in the 24 h before randomisation, blood culture does not need to be repeated at Visit 1a or 1b. If blood culture is positive, further cultures should be taken at each subsequent visit until culture becomes negative up to and including the Visit 4. Blood cultures do not need to be repeated if the previous culture is negative unless clinically indicated. Blood cultures should be performed between TOC and STFU in cases of relapse/new infection
  6. e Ensure PK sampling performed (< 29 weeks PMA) or samples scavenged (both (< 29 weeks PMA and ≥ 29 weeks PMA groups) at the appropriate time interval
  7. f Only participants in optimised arm
  8. DNA deoxyribonucleic acid, EVT End of actual vancomycin therapy, PCR polymerase chain reaction, PK pharmacokinetic