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Table 3 Schedule of assessments

From: Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial

 

Study period

  

Day 0

Study visits and procedures

Pre-consent (standard care)

Pre-randomisation

Randomisation

Day 1–2

Day 3–5

Day 6–14

Day 28

Pre-consent eligibility screening

 Eligibility screening as appropriate (as per standard care), e.g., ANC, AST/ALT, creatinine, blood culture. When available, Hb, platelets, CRP, albumin, lactate

X

      

Informed consent

 Informed consent obtained

 

x

     

Pre-randomisation eligibility and assessments

 Eligibility screening as appropriate (non-standard care) e.g., pregnancy test, MASCC score, max temp prior to randomisation, signs/symptoms of sepsis

 

x

     

 EQ-5D-5 L

 

x

     

Randomisation

 Standard care antibiotic administration

X

x

x

x

x

  

 Intervention (early switch) antibiotic administration (IV antibiotics will commence prior to informed consent)

X

x

x

x

x

  

 Research blood sample

  

x

    

 GP letter sent

  

x

    

Baseline assessments to be completed on CRF after eligibility is confirmed

 Demographics, vital signs, cancer, medical and SACT history, hospital admission details

 

x

     

 Concomitant medications

 

x

x

x

x

x

 

 Relevant microbiological results

 

x

x

x

x

x

 

Daily data collection

 Antibiotic regimen

X

x

x

x

x

x

 

 Highest daily temperature (whilst inpatient or temperature recorded if unwell as an outpatient)

X

x

x

x

x

x

 

Protocol compliance

 Adherence to protocol specified intervention

   

x

x

  

Patient follow-up

 Survival status

     

x

x

 EQ-5D-5 L

     

x

 

 Patient follow-up questionnaire

     

x

 

 New medications

     

x

x

 Changes to next planned SACT cycle

      

x

 Hospital discharge/re-admission/critical care admission details

     

x

x

 Recording and reporting of adverse events

     

x