Background <p>Newer oxazolidinones will be required to advance regimens in pan-TB indications. The addition of host-directed agents may help promote the recovery of lung function during TB treatment and prevent post-TB lung disease.</p> Methods <p>The panTB-HM trial assesses the capacity of three novel regimens containing the oxazolidinone sutezolid and the antioxidant N-acetylcysteine (NAC) to meet the target criteria proposed by WHO for pan-TB indications (including use without rifamycin susceptibility testing and of 4&#xa0;months or less duration) in a phase 2C trial.</p> Discussion <p>This trial is ground-breaking in its objectives and design for a 4-month pan-TB indication (in a non-inferiority comparison to standard treatment) and its evaluation of lung function recovery (in a superiority comparison).</p> Trial registration <p>ClinicalTrials.gov NCT05686356. Registered on 13 Jan 2023</p>

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panTB-HM: a multi-arm clinical trial of a pan-TB regimen targeting both host and microbe

  • D. Mudzengi,
  • S. Mashatole,
  • Q. Xiang,
  • C. Adrion,
  • N. Glover,
  • T. Ngwanto,
  • J. Mdluli,
  • S. Boniface,
  • M. Rassool,
  • B. Matome,
  • L. Paramo,
  • E. Svensson,
  • A. Fasanmi,
  • S. Angelo,
  • M. Moyo,
  • C. Marx,
  • C. Khosa,
  • L. Mokaba,
  • N. Mofokeng,
  • J. Lalashowi,
  • C. Nacy,
  • S. Charalambous,
  • E. Fumane,
  • V. Maphossa,
  • T. Beattie,
  • W. Brumskine,
  • C. Venter,
  • D. Mapamba,
  • N. Heinrich,
  • S. Rajaram,
  • S. Kooverjee,
  • L. Botha,
  • M. Nell,
  • A. Easton,
  • S. Foraida,
  • Robin Mark Warren,
  • Issa Sabi,
  • N. Ntinginya,
  • R. S. Wallis,
  • Alcina Zitha,
  • Cynthia Silva,
  • Rezelda Macuiana,
  • Catildo Cubai,
  • Jéssica Boque,
  • Ducilia Matimbe,
  • Supinho Chibandje,
  • Sofia Ligeiro,
  • Erlandy Basson,
  • Andrea Rachow,
  • Nisha Naidoo,
  • Joan Nyanhongo,
  • Emilia de Klerk,
  • Engela du Plooy,
  • Kgothatso Precious Tau,
  • Caroline Mokhoko,
  • Mabika Christian Kasongo,
  • Lethabo Colleen Theko,
  • Jack Ruele,
  • Obakeng Peter Booi,
  • Mando Mmakhora Thaba,
  • Seasebeng Pertunia Mothobi,
  • Ni Ni Sein,
  • Kamogelo Fortunate Matlhase,
  • Moshukutjoane Lebogang Maila,
  • Phillip Mafori Mphahlele,
  • Hitekani Kgomotso Theko,
  • Tshegofatso Magnus Ramatlhape,
  • Melissa Neo Senne,
  • Nondzakazi Mnqonywa,
  • Rendani Helen Ngwagwe,
  • Sifiso Cornelius Shezi,
  • Nosisa Charity Mkhize,
  • Mmarona Elizabeth Lekalakala,
  • Chantal Onkgopotse Molotsi,
  • Kabelo Letshwiti,
  • Rose Kgothatso Masilo,
  • Siyabonga Nhlapo,
  • Jaszmin Neo Rakuba,
  • Ketlhomogetswe Magdeline Molatlhegi,
  • Malebogo Matsopyane Mampane,
  • Aluwani Adolf Thovhakale,
  • Johanna Alida Baumgarten,
  • Sheily Christina Lekotloane,
  • Karabo Molefe,
  • Primrose Ketshepile Ketshepile Motswenyane,
  • Mmalebone Realeboga Ntantiso,
  • Lesego Letlole,
  • Siphiwe Mabote,
  • Refilwe Gontse Powane,
  • Ruth Ntombikaise Tyobeka,
  • Aruna Bhoola,
  • Tebatso Matsepe,
  • Nthati Nke,
  • Themba Phakathi,
  • Zithelo Zikalala,
  • Sylvester Magwasha,
  • Leon Spies,
  • Vuyokazi Jezile,
  • Coreen Barker

摘要

Background

Newer oxazolidinones will be required to advance regimens in pan-TB indications. The addition of host-directed agents may help promote the recovery of lung function during TB treatment and prevent post-TB lung disease.

Methods

The panTB-HM trial assesses the capacity of three novel regimens containing the oxazolidinone sutezolid and the antioxidant N-acetylcysteine (NAC) to meet the target criteria proposed by WHO for pan-TB indications (including use without rifamycin susceptibility testing and of 4 months or less duration) in a phase 2C trial.

Discussion

This trial is ground-breaking in its objectives and design for a 4-month pan-TB indication (in a non-inferiority comparison to standard treatment) and its evaluation of lung function recovery (in a superiority comparison).

Trial registration

ClinicalTrials.gov NCT05686356. Registered on 13 Jan 2023