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Table 2 Study schedule

From: Improving the radical cure of vivax malaria (IMPROV): a study protocol for a multicentre randomised, placebo-controlled comparison of short and long course primaquine regimens

 

Day

Week

Month

     

Rec

Age > 60 m

Age 12–60 m

Age 6–< 12 m

 

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14a

17a

3

4

5

6

7

8

3

4

5

6

7

8

9

10

11

12

 

vol

freq

total

vol

freq

total

vol

freq

total

History of fever, current axillary temperature

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

         

Full medical history, vital sign, physical examination

X

                                         

MUAC & weight

X

                     

X

  

X

  

X

  

X

X

         

Ask about any concomitant medication

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

         

Symptom checklist

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

         

Asses for any indication for study withdrawal

 

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

         

Interviews to asses cost-of-illness

X

            

X

X

                 

X

         

Urine pregnancy test

X

                               

X

         

Masimo puls-oximeter-main study

X

X

X

X

   

X

     

X

                            

Masimo puls-oximeter-G6PDd arm

X

X

X

X

   

X

      

X

                           

Drug treatment

                                          

 Standard schizontocidal theraphy

X

X

X

                             

X

         

 PQ-main study

X

X

X

X

X

X

X

X

X

X

X

X

X

X

                  

X

         

 PQ-G6PDd arm

X

      

X

      

X

 

X

X

X

X

X

           

X

         

Capillary sample-microtainer up to 400 μL

                                 

0.4

26

10.4

0.4

26

10.4

0.4

26

10.4

 G6PD flourescent spottestb

X

                                         

 G6PD rapid test

X

                                         

 Parasite microscopyb

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

         

 Rapid diagnostic test for malariab

X

                                         

 Haemoglobin HemoCueb-main study

X

  

X

   

X

     

X

  

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

         

 Haemoglobin HemoCueb-G6PDd arm

X

  

X

   

X

  

X

   

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

         

 Serology

X

                

X

   

X

X

  

X

  

X

  

X

X

         

 Parasite genotype

X

                               

X

         

EDTA venous samplec

                                          

 From D0 EDTA: FBC, G6PD, HP, PG, serol, DC

X

                                

5

1

5

2

1

2

0.5

1

0.5

 From D7 & 13: FBC, DC

       

X

    

X

X

                   

5

2

10

2

2

4

0.5

2

1

 EDTA Month 6: FBC, G6PD, pPCR, Serol

                         

X

       

5

1

5

2

1

2

0.5

1

0.5

 EDTA each recurrence: FBC PG, Serol, DC

                                

X

5

2

10

2

2

4

0.5

2

1

Total blood volumes-2 malaria recurrence

                                   

40.4

  

22.4

  

13.4

Total blood volumes-no recurrence malaria

                                   

30.4

  

18.4

  

12.4

  1. aG6PDd arm only
  2. bin some centres these tests are routine & do not need to be repeated
  3. cif a venous sample cannot be obtained, obtain a capillary sample into a Microtainer