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Table 3 Trial organizational timetable

From: A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

 

Screening Treatment

      

Follow-up

        

Visit number

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18 (G)

18 (T)

Weeks (W)

W −1

W 0

W4

W 8

W 12

W 16

W 20

W 24

W 28

W 36

W 44

W 52

W 60

W 72

W 84

W 96

W 108

W 112

W120

Demographics

X

                  

Medical history

X

                  

Previous treatment

X

                  

Inclusion and exclusion criteria

X

X

                 

Subject information Informed Consent

X

                  

Physical examination

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Xa

Xb

Pregnancy test

X

    

Xa

 

Xb

           

HIV test

X

                  

Laboratory tests and B/Sc

X

Xd

X

X

Xf

Xa

 

Xb

           

12-lead ECG

X

 

X

X

 

Xa

 

Xb

           

MGIT test

X

                  

Sputum smear

X

  

X

X|e

X

X

X

X

X

X

X

X

X

X

X

X

X A

Xb

Sputum culture

X

  

X

X|e

X

X

X

X

X

X

X

X

X

X

X

X

Xa

Xb

Indirect drug susceptibility testing

X

  

X

 

X

X

X

X

X

X

X

X

X

X

X

X

Xa

Xb

Chest X-ray

X

    

Xa

 

Xb

           

Randomization

 

X

                 

Adverse events/and events

  

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Xa

Xb

Concomitant therapy check

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Xa

Xb

Compliance check

  

X

X

X

X

Xb

Xb

           
  1. aOnly for patients randomized in gati arm.
  2. bOnly for patients randomized in control arm.
  3. cLaboratory tests include: full blood count, kalaemia, creatinin, ASAT, ALAT, amylasemia, glycemia (blood glucose is measured twice during the screening).
  4. dBlood glucose levels is measured 4 h after the first dose of medication, and at fasting stage on days 8 and 15, and week 12.
  5. eIf sputum smears are still positive at week 8.
  6. fOnly blood glucose level is measured at week 12.