Showing 1–25 of 47 documents
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Nicholas I Paton, Christopher Cousins, Intan P Sari, Erlina Burhan, Nan-Kai Ng, et al.
…D:** WHO recommends a 2-month optimal duration for new drug regimens for rifampicin-susceptible tuberculosis. We aimed to investigate the efficacy and safety of the 8-week regimens that were assessed as part of the TRUNCATE management strategy of the TRUNCATE-TB trial. **METHODS…
Yilin Zhang, Yang Li, Yan Ren, Ting Li, Yajiao Xing, et al.
…great threat to global health. Increasing evidence of novel regimens in trial settings has risen, but the combinations of oral shorter regimens have not been optimised. An evaluation of the efficacy and safety of short-term regimens utilizing various drug combinations is essentia…
Nusrat Shafiq, Ashok Kumar, Vikram Vohra, Gopal Krishan Khuller, Manjula Singh, et al.
**BACKGROUND:** Clofazimine, an antimycobacterial agent, has demonstrated efficacy in reducing the treatment duration for MDR TB. **OBJECTIVES:** To determine whether a 16 week clofazimine-based regimen is non-inferior to the standard 24 week regimen for drug-susceptible pulmona…
Feng Sun, Yang Li, Yilin Zhang, Cui Cai, Yuanyuan Chen, et al.
**OBJECTIVES:** Despite advancements in shorter, oral regimens for drug-resistant tuberculosis, more options are needed to extent patient benefits. We conducted a trial to evaluate the noninferiority of an all-oral regimen compared with the injectable-containing regimen. **METHO…
John Z Metcalfe, Isabelle R Weir, Kimberly K Scarsi, Alberto Mendoza-Ticona, Samuel Pierre, et al.
**BACKGROUND:** Based on results from preclinical and clinical studies, a five-drug combination of isoniazid, rifapentine, pyrazinamide, ethambutol, and clofazimine was identified with treatment shortening potential for drug-susceptible tuberculosis; the Clo-Fast trial aimed to d…
Nida Khan, Muhammad Ahmar Khan, Naila Muzaffar, Ahmad Ismail, Abdul Ghafoor, et al.
…according to the global estimates. Novel all oral treatment regimens containing new antibiotics with reduced treatment duration are available. World Health Organization guidelines recommend the use of shorter all-oral regimens under operational research. To guide recommendations,…
Pawandeep Kaur, Lelia H Chaisson, Zana Wangari Kiragu, Praewpannarai Buddadhumaruk, Ariana F Austin, et al.
…-TB) are based on clinical trials evaluating fixed duration regimens. However, when a regimen succeeds, it remains unknown whether a shorter duration could yield the same results. Similarly, if a regimen fails, it is unclear whether extending the treatment could improve outcomes.…
Grace Montepiedra, Lisa Aaron, Gerhard Theron, Katie McCarthy, Sarah Bradford, et al.
**BACKGROUND:** TB APPRISE (IMPAACT P1078), a Phase IV randomized, multi-country non-inferiority trial assessing the safety of 28 weeks of isoniazid preventive therapy (IPT) initiated during pregnancy (immediate IPT) versus deferring to week 12 postpartum (deferred IPT) in people…
Linda J Harrison, Gustavo E Velásquez, Russell R Kempker, Marjorie Z Imperial, Eric Nuermberger, et al.
…context of drug-resistant TB, offers promise for additional regimens for persons with DS-TB, provided they are sufficiently effective and well-tolerated. We spotlight wave 1 of the RAD-TB platform trial (ACTG A5409, NCT06192160) that will investigate new chemical entities for the…
Ekaterina V Kurbatova, Kelly E Dooley, Wendy Carr, Jason E Stout, Eric L Nuermberger, et al.
…ized controlled phase 2C trial that compares two four-month regimens, BMZ plus rifabutin (Rb) (2BMZRb/2BMRb) or BMZ plus delamanid (D or DLM) (2BMZD/2BMD), with standard 6-months isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE). All drugs are administered seven days per w…
D Mudzengi, S Mashatole, Q Xiang, C Adrion, N Glover, et al.
…KGROUND:** 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 capa…
Ekaterina V Kurbatova, William C Whitworth, Kia E Bryant, Meredith G Dixon, Kelly E Dooley, et al.
A previous study demonstrated noninferior efficacy of 4-month rifapentine/moxifloxacin regimen for tuberculosis (TB) treatment compared with the standard regimen. We analyzed pregnancy outcomes of women who became pregnant during the study. Among 740 women, 97 (13.1%) became…
Kamila Romanowski, Yen Pham Ngoc, Leila Barss, Elias Jabbour, James C Johnston, et al.
…eration when implementing tuberculosis preventive treatment regimens (TPT). We used data from a phase 2b randomized trial of TPT to estimate overall cost and key drivers of costs for two TPT regimens. **METHODS:** We did a post-hoc analysis of 915 participants aged ≥10 ye…
Lorenzo Guglielmetti, Uzma Khan, Gustavo E Velásquez, Maelenn Gouillou, Muhammad Hammad Ali, et al.
…at this patient population might require longer, reinforced regimens. **FUNDING:** Unitaid, Médecins Sans Frontières, Partners In Health, Interactive Research and Development, Ramón Areces Foundation, the Jung Foundation for Science and Research, Research Foundati…
Laura Diab Casares, Juan Espinosa Pereiro, María Teresa Tórtola Fernández, Xavier Casas García, Joan Pau Millet, et al.
…ceptible (DS)-TB with equal or better efficacy than current regimens. A promising approach to achieve this is the combination of dose-optimised repurposed drugs. **METHODS AND ANALYSIS:** The RML-TB trial is a phase IIb, randomised, non-inferiority, controlled, open-label, multi…
Weijian Liu, Tian He, Senlin Zhan, Hongjuan Qin, Jianfeng Zeng, et al.
**BACKGROUND:** One month of daily rifapentine plus isoniazid (1HP) is a new regimen for tuberculosis (TB) infection to lower the incidence of active TB. However, it has not been prescribed for Chinese children, and the optimal dosage of daily rifapentine for children remains con…
Bella Devaleenal Daniel, Sivakumar Shanmugam, Rashi Mehta, Manpreet Bhalla, Muthuvijayalakshmi Mariappan, et al.
…fectiveness of bedaquiline, pretomanid and linezolid (BPaL) regimens with varying doses and duration of linezolid at the end of 48 weeks post treatment among drug resistant tuberculosis (DR TB) patients. **METHODS:** Multicentric pragmatic randomized clinical trial in which BPaL…
Julie Huynh, Chishala Chabala, Suvasini Sharma, Louise Choo, Varinder Singh, et al.
…randomised clinical trial. Trials evaluating ATT shortening regimens using high-dose rifampicin and drugs with better central nervous system penetration alongside adjuvant anti-inflammatory therapy are needed to improve outcomes. **METHODS AND ANALYSIS:** Thehortened Intensive T…
Betina Durovni, Marcelo Cordeiro-Santos, Solange Cesar Cavalcante, Renata Spener-Gomes, Jamile Garcia, et al.
…HP (3HP) is uncertain. We compared treatment with these two regimens in people with a positive latent tuberculosis infection test and without HIV infection. We hypothesized that 1HP would have greater treatment completion and fewer targeted safety events than 3HP. **METHODS AND …
Patrick P J Phillips, Charles A Peloquin, Timothy R Sterling, Pawandeep Kaur, Andreas H Diacon, et al.
Evaluation of optimal dosing has generally been inadequate during tuberculosis (TB) drug development. Fluoroquinolones are central to TB treatment.To determine the dose of levofloxacin needed to achieve maximal efficacy and acceptable safety and tolerability as part of a multidru…
Anushka Naidoo, Kogieleum Naidoo, Marothi P Letsoalo, Roeland E Wasmann, Gillian Dorse, et al.
…ravir group) during tuberculosis treatment, then once-daily regimens through to 48 weeks. Participants were allocated into study arms by use of an electronic randomisation system generated by the study statistician. Participants underwent clinical and safety visits, including HIV…
Hamu J Mlyuka, Alphonce Liyoyo, Belinda Nyaulingo, Emmanuel Mpolya, Oscar L Kaswaga, et al.
**BACKGROUND:** Current combination antibiotic treatment for drug-susceptible tuberculosis (DS-TB) usually takes 6 months to complete. This long duration can compromise clinical outcomes. Although a 4-month regimen including an optimized dose of rifapentine plus moxifloxacin is n…
Thibaut Gelé, Daniel Atwine, Elisabeth Baudin, Winnie Muyindike, Kenneth Mworozi, et al.
…atients with HIV-TB coinfection using two rifampicin dosing regimens (10 and 20 mg/kg/day) and EFV dosing (600 and 800 mg q24h). **METHODS:** Ninety-seven patients were assigned to three arms in a randomized clinical trial conducted in Uganda. Plasma concentrations…
Jose M Calderin, Juan Eduardo Resendiz-Galvan, Noha Abdelgawad, Angharad Davis, Cari Stek, et al.
**BACKGROUND:** Dexamethasone is recommended as adjunctive therapy for tuberculous meningitis (TBM). Co-administration with rifampicin is expected to reduce dexamethasone exposure in TBM, an effect that may be more pronounced with the higher rifampicin doses currently being evalu…
Weijian Liu, Nuo Xu, Wei Li, Wen Yao Mak, Tian He, et al.
**OBJECTIVES:** To assess the safety of 4-week daily rifapentine-isoniazid regimen in latent tuberculosis for Chinese children, and to provide paediatric-specific evidence for extrapolating adult dosing strategies to children. **METHODS:** An open-label, prospective, single-arm …