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Table 1 Schedule of events

From: Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial

SCHEDULE OF EVENTS

Protocol Activities and Forms to Be Completed

Screening (day)

Treatment (day)

 

At Follow-up after day 301

   

-2

-3

   

4

5

6

7

        

21

    

Day 60 Day 210

Consent form &

                         
           

X

      

X

 

X

 

X

 

X

X

 

X

                    

X

  

X 2

rK39 dipstick

X

                        

ECG

X

         

X

      

X

       
 

X

         

X

      

X

     

X

 
 

X

     

X

   

X

      

X

     

X

 
 

X

         

X

      

X

   

X

   
 

X

         

X

      

X

   

X

 

X

X

      

X

X

X

X

X

X

X

X

X

X

          
     

X

                    
      

X

X

X

X

X

X

X

X

X

X

          
     

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 

X

 

X

   

PK study for Miltefosine - Arm 2 - A dults5

     

X6

 

X

  

X

   

X

        

X

X

PK study for Miltefosine - Arm 2 - Children5

     

X6

    

X

   

X

        

X

X

PK study for Miltefosine - Arm 3 - A dults5

    

X6

 

X

   

X

      

X

 

X

 

X

 

X

X

PK study for Miltefosine - Arm 3 - Children5

    

X6

     

X

      

X

   

X

 

X

X

Volume of blood (ml) taken from Group 2 - children

7.5

    

2.5

2.5

   

10.5

   

0.5

  

10

   

7.5

 

7.5

7.5

Volume of blood (ml) taken from Group 3 - children

7.5

   

2.5

 

2.5

   

10.5

      

10.5

   

8

 

7.5

7.5

  1. 1 Patients assessment between day 60 and 210 in the event of any medical problems. Blood count, biochemistry, liver function tests parasitology and PK analysis will be done in the event of such a visit. At the day 210 visit, flexibility (of +/- 30 days) will be allowed for timing due to practical difficulties patients may face to meet exact timing of visits.
  2. 2 Parasitology will be done in the follow up period after day 28 if clinically indicated (i.e. if reappearance of symptoms and signs of VL).
  3. 3 2.5 ml of EDTA blood for Complete blood count; and only 0.2 ml EDTA blood used for PCR
  4. 4 7.5 ml blood for urea, creatinine, liver function test.
  5. 5 The PK study will be done on the specified days with 2.5 ml of EDTA blood taken before/after and 0.5 ml during treatment (the possible use of dried blood spots is currently under investigation).
  6. 6 On first day of Miltefosine treatment, blood samples will be drawn 3 times: just prior to first dose, 4 & 8 hours post-dose to assess the absorption-phase of miltefosine (total volume needed 2.5 ml).
  7. Volumes of blood required for children are shown in bottom two rows. In total, 41.5 ml are required in the first 1 month during admission in group 3 and 41 ml for group 2.
  8. Clinical assessments will include pulse, blood pressure, temperature, weight, height (done only at baseline), spleen size, liver size.
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Trials

ISSN: 1745-6215