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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.