Table 1.
Lack of Inclusion of Pregnant Women in Ongoing and Planned Phase 3/4 Treatment-Shortening Trials for Active Tuberculosis
| Triala | TB Type | Drugs in Regimens Under Study | Pregnant Women |
|---|---|---|---|
| NIX-TB (NCT02333799) | XDR | BDQ, LZD, Pa | No |
| NEXT (NCT02454205) | MDR | BDQ, LZD, LFX, PYZ, ± HD INH or ETO | No |
| TB-PRACTECAL (NCT02589782) | MDR/XDR | BDQ, LZD, Pa, ± MFX or CFZ | No |
| STREAM II (NCT02409290) | MDR | CFZ, ETO, MFX, PYZ, INH, KAN, PTO, CFZ, ETO, MFX, PYZ, INH, PTO, BDQ, CFZ, ETO, MFX, PYZ, INH, KAN, PTO, BDQ | No |
| STAND (NCT02342886) | DS | Pa, MFX, PYZ | No |
| TBTC Study 31 (NCT02410772) | DS | INH, PYZ, HD RPT, ± MFX or ETO | No |
| TRUNCATE-TB | DS | INH, PYZ, HD RIF, E, ± CFZ or LZD, INH, PYZ, RPT, LZD, LFX, INH, PYZ, ETO, LZD, BDQ, INH, PYZ, LZD, LFX, DLM | No |
| endTB | MDR | CFZ, DLM, MFX, PYZ, CFZ, BDQ, LFX, LZD, PYZ, CFZ, DLM, LFX, LZD, PYZ, BDQ, LZD, MFX, PYZ, BDQ, DLM, LZD, LFX, PYZ | No |
Abbreviations: BDQ, bedaquiline; CFZ, clofazimine; DLM, delamanid; DS-TB, drug-sensitive tuberculosis; E, ethambutol; ETO, ethionamide; HD, high dose; INH, isoniazid; KAN, kanamycin; LFX, levofloxacin; LZD, linezolid; MDR-TB, multidrug-resistant tuberculosis; MFX, moxifloxacin; Pa, pretomanid; PTO, protionamide; PYZ, pyrazinamide, RIF, rifampin; RPT, rifapentine; TBTC, Tuberculosis Trials Consortium; XDR-TB, extensively drug-resistant tuberculosis.
aNational Institutes of Health clinical trial identifiers are shown; for more information, go to ClinicalTrials.gov.