From: A systematic review of endpoint definitions in late phase pulmonary tuberculosis therapeutic trials
Trial registry IDa | Trial datesb | Location of sites | Sample size | Participant age (years) | Inclusion of participants with HIV infection | Intervention | Control | Total trial duration | Analysis | Current status |
---|---|---|---|---|---|---|---|---|---|---|
DS-TB | ||||||||||
TBTC Study 22, NCT00023335 | Reg: 10Sept2001 [reg. after end of trial] SC: March 2001 | USA Canada | 1004 | ≥ 18 | No, excluded | Once-weekly rifapentine and isoniazid in CP | Standard 6-month control (twice-weekly CP) | 30 months | Non-inferior [6.6%] | Completed and published [18] |
ACTG222, NCT00001033 | Reg: 31Aug2001 SC: July1997 | USA | 650 | ≥ 13 | Yes, with restrictions | A 9-month intermittent regimen with or without addition of levofloxacin | Standard 6-month control | 1.5 years | Equivalence [<10%] | Completed and published [19] |
Study C, NCT00216333 | Reg: 22Sep2005 PC: 6Sep2008 SC: 6Sep2009 | Africa, Asia, Latin America | 1585 | 18–65 | Yes, if CD4 ≥350 | Fixed dose combination 6-month regimens | Standard 6-month control (separate tablets) | 30 months | Non-interior [4%] | Completed and published [20] |
Oflotub, NCT00216385 | Reg: 22Sep2005 SC: Dec2008 | Benin, Kenya, South Africa,Senegal Guinee-Conakry | 2070 | 18–65 | Yes, with restrictions | A 4-month gatifloxacin regimen | Standard 6-month control | 2 years | Non-inferior [6%] | Completed and published [21] |
DMID-01-009, NCT00130247 | Reg: 15Aug2005 PC: 2Sep2008 SC: 28Nov2008 | Uganda Brazil Philippines | 394 | 18–60 | No, excluded | A 4-month standard 4-drug regimen | Standard 6-month control | 30 months | Equivalence [5%] | Completed and published [22] |
NIRT TRC Study 24, CTRI/2008/091/000024 | Reg: 5Sep2008 | India | 1371 | 18–60 | No, excluded | A 4-month regimens with moxifloxacin | 6-month regimen: 2 RHZE thrice weekly/4 RH thrice weekly | 28 months | Equivalence [5%] | Completed and published [23] |
Rifaquin, ISRCTN44153044 | Reg: 15Aug2008 PC: 1Nov2012 SC: 1Nov2012 | South Africa, Zimbabwe, Botswana, Zambia | 827 | ≥ 18 | Yes, if CD4 ≥200 | A 4-month and 6-month intermittent regimens with rifapentine and moxifloxacin | Standard 6-month control | 18 months | Non-inferior [6%] | Completed and published [24] |
REMOX, NCT00864383 | Reg: 18Mar2009 PC: Oct2013 SC: Feb2014 | China, India, Malaysia, Mexico, Thailand, Zambia, Tanzania, Kenya, South Africa | 1931 | ≥ 18 | Yes, if CD4 ≥250 | A 4-month regimens with moxifloxacin | Standard 6-month control | 18 months | Non-inferior [6%] | Completed and published [25] |
NIRT Study 25, NCT00933790 | Reg: 7Jul2009 PC: 31Dec2016 SC: 30June2018 | India | 331 | ≥ 18 | Yes | Daily, partly daily and intermittent 6-month regimens | Standard 6-month control | 18 months | Superiority using survival analysis | Completed and published [26] |
Study A, ISRCTN19832141 | Reg:15Apr2010 SC: 1Dec2001 | Benin, China, Guinea, Mozambique, Nepal, Tanzania | 1355 | 15–65 | Yes | A 8-month regimen based on ethambutol and isoniazid | Standard 6-month control | 18–20 months | Equivalence [5%] | Completed and published [27] |
NIRT Study 22, CTRI/2012/10/003060 | Reg: 15Oct2012 Trial terminated | India | 429 | 18–70 | No, excluded | A 4-month moxifloxacin and ofloxacin regimens given intermittently | Standard 6-month control given thrice weekly | 30 months | Equivalence [5%] | Completed and published [28] |
OneRIF,NCT02153528 | Reg: 3Jun2014 PC: 1 Aug2017 SC: 1 Aug2017 | Bangladesh | 701 | ≥ 15 | No, excluded | High-dose rifampicin regimen for 6 months | Standard 6-month control | 18 months | Logistic regression | Completed and published [29] |
STAND, NCT02342886 | Reg: 21Jan2015 PC: Jan2018 SC: May2018 | Georgia, Uganda, Malaysia,Philippines, South Africa, Kenya | 284 | ≥ 18 | Yes, with restrictions | Pretomanid, moxifloxacin and pyrazinamide for 4- or 6-months | Standard 6-month control | 24 months | Non-inferior [12%] | Completed and published [30] |
TBTC Study 31, NCT02410772 | Reg: 8Apr2015 Est. PC: Apr2020 Est. SC: Dec2020 | US, Brazil, China, Haiti, Peru, India, Thailand, Vietnam, Kenya, Malawi, S.Africa, Uganda, Zimbabwe | 2516 | ≥ 12 | Staged approach, CD4 ≥ 100 | A 4-month rifapentine and moxifloxacin regimens | Standard 6-month control | 18 months | Non-inferior [6.6%] | Completed and published [31] |
Rifashort, NCT02581527 | Reg: 21Oct2015 Est. PC: Jan2021 Est. SC: Dec2021 | Botswana, Uganda, Guinea, Mexico, Nepal, Peru, Pakistan | Target: 654 | 18–65 | No, excluded | A 4-month regimens with high dose rifampicin | Standard 6-month control | 18 months | Non-inferior [8%] | Open torecruitment |
NIAID Predict, NCT02821832 | Reg: 4July2016 Est. PC: 31 Dec2021 Est. SC: 31Dec2022 | China, South Africa | Target: 1200 | 18–75 | No, excluded | Biomarker-driven 4- or 6-month RIF-based regimen | Standard 6-month control | 18 months | Non-inferior [7%] | In follow-up |
Shortened regimens for DS (Pulmonary) TB, NCT02901288 | Reg: 15Sep2016 Est. PC: Dec2018 Est. SC: Dec2018 | China | Target: 3900 | 18–65 | No, excluded | A 4.5-month regimen with levofloxacin | Standard 6-month control | 28.5 months | Non-inferior [5%] | Completed |
SimpliciTB, NCT03338621 | Reg: 9Nov2017 PC: 30Apr2020 Est. SC: 22Feb2022 | Brazil, Georgia, Russian Federation, Malaysia, Phillipines, South Africa, Tanzania, Uganda | 455 | ≥ 18 | Yes, with restrictions | Bedaquiline, pretomanid, moxifloxacin, pyrazinamide for 4 months | Standard 6-month control | 24 months | Non-inferior [12%] | In follow-up |
Truncate TB, NCT03474198 | Reg: 22Mar2018 Est. PC: 12Mar2022 Est. SC: 12Mar2022 | Indonesia, Thailand, Philippines, Singapore | Target: 900 | 18–65 | Staged approach, CD4 ≥200 | A 2–3-month regimens with new and repurposed drugs | Standard 6-month control | 96 weeks | Non-inferior [12%] | Open to recruitment |
Tri-Do-Re, NCT04260477 | Est. start: 7Feb2020 Est. PC: Nov2024 Est. SC: Nov2024 | Niger [9 supported clinics] | Target: 370 | No limit | Yes, with restrictions | High-dose retreatment regimen (6R3H3EZ) including pyridoxine | Standard 6-month control | 18 months | Logistic regression | Not yet recruiting |
CLO-FAST, NCT04311502 | Est. Start: 17Mar2020 Est. PC: 18Mar2022 | Malawi, South Africa, Zimbabwe, Brazil, Peru, Thailand, India, Haiti | Target: 185 | ≥ 18 | Yes, with restrictions | A 3-month rifapentine/clofazimine-containing regimen with CFX loading dose. | Standard 6-month control | 65 weeks | Superiority [Time to 12wk culture conversion] | Not yet recruiting |
DR-TB | ||||||||||
Stream I, ISRCTN78372190 NCT02409290 | Reg: 14Oct2010 SC: 31July2018 | Ethiopia, Mongolia, South Africa, Vietnam | 424 | ≥ 18 | Yes | A 9–11-month injectable regimen | Local SOCc | 132 weeks | Non-inferior [10%] | Completed and published [32] |
Delamanid, NCT01424670 | Reg: 29Aug2011 PC: 4Jul2016 SC: 4Jul2016 | Estonia, Latvia, Lithuania, Moldova, Peru, Philippines, South Africa | 511 | 18–69 | Yes, with restrictions | Delamanid (added to OBR) | Placebo (added to OBR) | 120 weeks | Time to SCC | Completed and published [33] |
Nix-TB, NCT02333799 | Reg: 7Jan2015 PC: 14Jan2019 Est. SC: 13Jul2020 | South Africa | 109 | ≥ 14 | Yes, if CD4 ≥50 but with restrictions | Linezolid + bedaquiline + pretomanid for 26 weeks | No control group | 30–33 months | % with unfavorable outcome | Completed and published [34] |
NEXT, NCT02454205 | Reg: 27May2015 Est. PC: Dec2020 Est. SC: Dec2020 | South Africa | 154 | ≥ 18 | Yes | A 6–9-month regimen containing bedaquliine and clofazimine and other anti-TB drugs | Conventional SOC regimen in South Africe | 21–27 months | Superiority [70%] | Completed |
TB Practecal, NCT02589782 | Reg: 28Oct2015 Est. PC: Dec 2022 Est. SC: Feb2023 | Uzbekistan, South Africa, Belarus | Target: 630 | ≥ 15 | Yes | 24 weeks of all-oral regimens of bedaquiline, linezolid and pretomanid with or without clofazimine or moxifloxacin | Local SOCc | 108 weeks | Non-inferior [12%] | Open to recruitment |
Stream II, ISRCTN18148631NCT02409290 | Reg: 10Feb2016 Est. SC:31Jul2022 | Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, Uganda | Target: 1155 | ≥ 15 | Yes, if CD4 ≥50 | A 6-month injectable regimen, a 9-month all-oral regimen, both with bedaquiline | 9–11 month injectable regimen | 132 weeks | Non-inferior [10%] | In follow-up |
endTB, NCT02754765 | Reg: 28Apr2016 Est. PC: Sep2020 Est. SC: Apr2021 | Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, South Africa | Target: 750 | ≥ 15 | Yes, with restrictions | A 6–9-month all-oral regimens | Local SOCc | 104 weeks | Non-inferior [12%] | Open to recruitment |
ZeNix-TB, NCT03086486 | Reg: 22Mar2017 PC: 14Jan2019 Est. SC: 13Jul2020 | Georgia, Moldova, Russian Federation, South Africa | 181 | ≥ 14 | Yes, with restrictions | Linezolid (at various doses, durations) + bedaquiline + pretomanid after 26 wks of treatment [4 groups] | No control group | 104 weeks | Lower bound of 95% CI >50% | In follow-up |
TB-TRUST, NCT03867136 | Reg:7Mar2019 Est. PC: 1Dec2021 Est. SC: 1Dec2022 | China | Target: 354 | 18–70 | No, excluded | PZA sensitivity-guided all oral ultra short regimen | WHO standardized shorter regimen | 84 weeks | Non-inferior [10%] | Open to recruitment |
endTB-Q, NCT03896685 | Reg: 1Apr2019 Est. PC: Oct2022 Est. SC: Dec2022 | India, Kazakhstan, Lesotho, Pakistan, Peru, Vietnam | Target: 324 | ≥ 15 | Yes | A 6–9-month all-oral regimen | Local SOCc | 104 weeks | Non-inferior [12%] | Open to recruitment |