Table 3. Predict TB study timeline.
Study enrollment began in Cape Town in June 2017 and is expected to begin in Henan in October 2017. Enrollment is expected to take about 3 years and the study is expected to complete within 5 years.
| Screening | D0 | W1
V
(D7) |
W2
(D14) |
W4
(D28) |
W8
D
(D56) |
W12
(D84) |
At Week 16 | W16 (D112) | W20
(D140) |
W24 (D168) | W36
(D252) |
W48
(D336) |
W60 (D420) | W72
(D504) |
TB
Recurrence |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study
Informed Consent (Plus Genetic and HIV in RSA) |
X | RANDOMIZE to Arm B or C | ||||||||||||||
|
Medical History/
Focused History |
X | X | X | X | X | X | X | X | X | X | X | X | phone
call |
X | X | |
|
Physical Exam/
Focused Physical Exam |
X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
| Sputum Collection ξ | ||||||||||||||||
| Smear/Culture | XX H | X | X | X | X | X | X | then | X | X | X | X | X | X | X | |
| GeneXpert | X | (X) S | X | X | X E | X (arms A
and B only) |
X | |||||||||
| Biomarkers | X | X | X g | X g | X g | X g | X g | X g | X g | |||||||
| Saliva | X | X | X | X | X | |||||||||||
| Blood collection | ||||||||||||||||
| CBC/Chems/LFT G | X | and if not assigned to Arm A, | X | |||||||||||||
| Biomarkers | X | X | X | X | X | X | X | X | X | X | ||||||
| Pregnancy
Test P (serum at screening, urine for others) |
x h(serum) | |||||||||||||||
| HIV Testing | X | X | ||||||||||||||
| Plasma drug levels | X (all arms) | |||||||||||||||
| Finger Stick | X | X | Arms
B/C and randomized A |
Randomized
for scan in Arm A only |
X | |||||||||||
| Urine collection | ||||||||||||||||
| Biomarkers | X | X | X | X | X | Review treatment completion criteria | X | X | X | X | X | |||||
| Pregnancy
Test P (serum at screening, urine for others) |
x (can do
if desired before CXR) |
X | X | Arms B and
C only |
Arm A only | X | ||||||||||
| FDG-PET/CT W | X | X | Arms
B/C and randomized A |
Randomized
for scan in Arm A only |
X | |||||||||||
|
Adherence
monitoring |
X | X | X | X | X | X | Arms A
and B only |
Arms A and
B only |
||||||||
Additional sputum may be collected if contaminated or otherwise compromised
A subject could be called back for this additional sputa collection, if necessary.
Sputum at screening will also be used for screening Xpert
May not be done if within 7 days of screening
Pregnancy testing from screening may be used for the D0 PET/CT scan if D0 is within 2 days of the screen
These will be performed at any visit if clinically significant.
Before any PET/CT scan or CXR is done, a pregnancy test will be done for applicable females. If the pregnancy test is positive, the PET/CT scan will not be performed.
For those eligible for randomization to Arms B/C
At week 8, ethambutol and pyrazinamide will be discontinued
PET/CT scan windows: baseline w/i 7 days after treatment initiation; W4 must be at least 4 wks after baseline scan with a -3/+7 d window; W16 and 24 scan w/i 14 d of visit; relapse ASAP, but w/i 2 wks of recurrence
Visit windows: Week 1–2: +/- 3 days; Week 4–24: +/- 7 d, noting that Weeks 16 and 24 should be as close as possible to actual date; Week 36–72: +/- 30 days.
If sputum is not available for biomarkers, it will not be a protocol deviation.