Reducing TB Treatment to four months

REDUCING TB TREATMENT TO FOUR MONTHS

Our trial, panTB-HM, responds to the Project to Accelerate New Treatments for Tuberculosis (PAN-TB). PAN-TB is a consortium of philanthropists seeking to accelerate the development of novel, shorter Tuberculosis treatments which are simpler to use and have better tolerability.

panTB-HM, a phase 2c trial, will test Sutezolid at 2 dose levels (1200 & 1600) to optimize its efficacy and safety. Sutezolid (a linezolid analog) is included in the regimen to confer a high barrier to new resistance while providing a level of safety and tolerability not possible with current oxazolidinones.

N-acetylcysteine, a re-purposed host-directed WHO essential medicine and a host-directed therapy, is included to protect the lung and liver against oxidative damage, preserve lung function, and accelerate the eradication of MTB infection by replenishing glutathione (GSH).
Treatment in the Sutezolid arms will be for four months, and that will be compared with the standard drug-sensitive TB regimen which is for six months.

We will randomly assign patients to 1 of 4 arms at a ratio of 1:1:1:1.
1. 4S1200BP
2. 4S1600BP
3. 4S1600BPN
4. 2HRZE/4HR (comparator arm)

S=Sutezolid
B=Bedaquiline
P=Pretomanid
H=Isoniazid
R=Rifampicin
Z=Pyrazinamide
E=Ethambutol