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Table 1 List of included trials and trial characteristics

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

  1. aThose registration numbers starting with “NCT”: represent ClinicalTrials.gov; “ISRCTN” = International Standard Randomised Controlled Trial Number, and “CTRI” = Clinical Trials Registry of India
  2. b“Reg date” The date the trial was first posted on the specified registry. “PC” Primary completion date, the date data collection was completed for all primary outcome measures; “SC” Study completion date, the date the last participant was examined or received an intervention to collect final data for the primary outcomes, secondary outcome measures, and adverse events.”Est.” indicates that date is an estimation
  3. cLocal standard of care (SOC) consistent with appropriate WHO guidelines at the time
  4. Abbreviations: SOC standard of care, OBR optimzed background regimen