Table 1. Overview of TB noninferiority treatment trials.
Indication | Study [Reference] | Regimen | Comparator | Delta | Outcome | Note |
---|---|---|---|---|---|---|
DSTB | Jindani, 2004 [19] | 8HRZE | 6HRZE | 5% | inferior | |
DSTB | Jindani, 2004 | 8HRZE (weekly*) | 6HRZE | 5% | inferior | |
DSTB | Gillespie, 2014 [17] | 4HRZM | 6HRZE | 6% | inferior | |
DSTB | Gillespie, 2014 | 4RZEM | 6HRZE | 6% | inferior | |
DSTB | Jindani, 2014 [18] | 4HRZM | 6HRZE | 6% | inferior | |
DSTB | Jindani, 2014 | 6HRZM | 6HRZE | 6% | noninferior | |
DSTB | Merle, 2014 [21] | 4HRZG | 6HRZE | 6% | inferior | |
DSTB _noncavitary | Johnson, 2009 [20] | 4HRZE | 6HRZE | 5% | inferior | |
DSTB noncavitary | Alipanah, 2016 [22] | 4HRZM/E | 6HRZE | 6% | noninferior | meta-analysis |
DSTB | Lienhardt, 2011 [24] | 6HRZE_fixed | 6HRZE_loose | 4% | noninferior | |
DSTB | Aseffa, 2016 [23] | 6HRZE fixed | 6HRZE_loose | 4% | noninferior | |
DSTB | TBTC Study 31 | 4RHE; 4RptZHE | 6HRZE | 6.6% | enrolling | |
DSTB + DRTB | STAND | PaMZ | 6HRZE | 12% | active, nonrecruiting | NCT02342886 |
MDRTB | STREAM [25] | 40–48 weeks | 18–24 months | 10% | noninferior | NCT02409290 |
MDRTB | endTB | 5 arms | SOC | 12% | enrolling | NCT02754765 |
MDRTB | PRACTECAL | 2 arms | SOC | 12% | enrolling | NCT02589782 |
* In the continuation phase.
Abbreviations: DRTB, drug-resistant TB; DSTB, drug-sensitive TB; E, ethambutol; G, gatifloxacin; H, isoniazid; M, moxifloxacin; MDRTB, multidrug-resistant TB; Pa, pretomanid; R, rifampicin; Rpt, rifapentine; SOC, standard of care; STAND, Shortening Treatments by Advancing Novel Drugs; TB, tuberculosis; TBTC, Tuberculosis Trials Consortium; Z, pyrazinamide.