Skip to main content

Table 1 Trial schedule

From: Oral versus intravenous antibiotics for patients with Klebsiella pneumoniae liver abscess: study protocol for a randomized controlled trial

Assessments

Pre-enrolment (routine care)

Screening

Once between day 0 and day 7

Day 2–3, rpt every 2-3d until negative

Any point in study period if temp ≥38°C and any other secondary infection suspected

Daily

Every 7 days (+/- 3d)

Day 28 (+/- 3d)

Day 42 (+/- 3d) (if oral continued)

Day 56 (+/- 3d) (if oral continued)

Day 70 (+/- 3d) (if oral continued)

Day 84 (+/- 7d)

Informed consent

 

X

          

Randomisation

 

X

          

Demographics

 

X

          

Past medical history1

 

X

          

Antibiotic history

 

X2

    

X3

X3

X3

X3

X3

X3

Symptom assessment4

 

X

    

X

X

X

X

X

X

Temperature

 

X

   

X5

X6

X

X

X

X

X

Physical examination7

 

X

    

X

X

X

X

X

X

Screen metastatic complications8

 

X

    

X

X

X

X

X

X

Adverse event monitoring

      

X

X

X

X

X

X

Adherence check

      

X

X

X

X

X

X

Ophthalmology assessment

  

X

         

FBC

 

X9

    

X

X

X

X

X

X

RP1

 

X9

    

X

X

X

X

X

X

LFT

 

X9

    

X

X

X

X

X

X

CRP

 

X9

    

X

X

X

X

X

X

Procalcitonin

 

X9

    

X

X

X

X

X

X

Urine pregnancy test

 

X9

          

G6PD

 

X10

          

Blood cultures

+/-

X11

 

X

X

       

Chest X-ray

 

X11

          

Abdominal CT or US

X12

      

X13

 

X14

 

X15

Abscess drainage16

+/-

           

Abscess fluid culture16

+/-

           

Study drug

     

X

      

Subject diary of healthcare expenses

     

X

      

Quality of Life Survey

 

X

     

X

   

X

  1. 1Full medical history including comorbidities, current medications, drug allergies, presenting and current symptoms. 2Document all antibiotics taken during this treatment episode up until enrollment. 3Include study drug and any additional antibiotics given. 4Standardized checklist. 5Self recorded daily temperature recording at home post discharge until Day 28 or until meeting criteria for clinical response. 6Self recorded weekly temperature recording at home after meeting criteria for clinical response, with weekly reminder call from the study team. 7Measurement of blood pressure, heart rate, and cardiovascular, respiratory and abdominal examination. 8Screen consists of standardized checklist of symptoms and signs, which if present trigger relevant investigations. 9If not already done in previous 48 hours. 10Only in patients whose K. pneumoniae tests resistant to ciprofloxacin, and those with contraindications to ciprofloxacin. 11If not already done in previous seven days. 12Scans must be within the preceding seven days. 13Day 28 scan to be performed within three days prior to the Day 28 visit. 14Day 56 scan to be performed within three days prior to the Day 56 visit, only in those patients failing to meet criteria for clinical response at day 42. 15Day 84 scan to be performed within three days prior to the Day 84 visit, only in those patients failing to meet criteria for clinical response at day 70. 16At any point during the current treatment episode.
Back to article page

Trials

ISSN: 1745-6215