While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.

Start Date15 Jan 2025

Sponsor / Collaborator

The Johns Hopkins University

NCT05917340

/ Not yet recruitingPhase 3IIT

Comparative Evaluation of Intensified Short Course Regimen and Standard Regimen for Adults TB Meningitis : an Open-label Randomized Controlled Trial

Tuberculous meningitis (TBM) is the most lethal form of extra pulmonary tuberculosis. This devastating disease kills almost a third of its sufferers and disables a significant proportion of the survivors. TBM poses one of the most difficult diagnostic and therapeutic challenges in modern clinical practice. High-quality robust clinical trials have made a considerable contribution to the treatment of pulmonary tuberculosis in the last four decades. However, evidence from such clinical trials is lacking in TBM and the treatment remains uncertain. There is a significant variation in the choice, dose and duration of drugs between countries, institutions and clinicians. Investigators propose a multi-centric open-label clinical trial to assess the efficacy of short-course anti-TB drugs with high dose rifampicin, and moxifloxacin along with conventional anti-TB drugs and adjuvant therapy with aspirin and corticosteroids. Controls will receive standard treatment as per national guidelines for TBM. The investigators also aim to assess the safety and tolerability of high-dose Rifampicin and Moxifloxacin and the Pharmacodynamics and Pharmacokinetics parameters of ATT (Rifampicin, INH, Moxifloxacin and Pyrazinamide) in CSF between the two groups

Start Date01 Mar 2024

Sponsor / Collaborator

Indian Council of Medical Research

[+3]

NCT05630872

/ RecruitingPhase 2IIT

Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

A5406 hypothesizes that dolutegravir (DTG) 50 mg taken twice daily will provide adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated TB.

Start Date13 Feb 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

100 Clinical Results associated with Pyrazinamide

100 Translational Medicine associated with Pyrazinamide

100 Patents (Medical) associated with Pyrazinamide

7,485

Literatures (Medical) associated with Pyrazinamide

31 Dec 2025·Emerging Microbes & Infections

The epidemiology and gene mutation characteristics of pyrazinamide-resistant Mycobacterium tuberculosis clinical isolates in Southern China

Article

Author: Lai, Xiaomin ; Meng, Fanrong ; Chen, Yuanjin ; Hu, Jinxing ; Wei, Zeyou ; Niu, Qun ; Yang, Yu ; Wang, Nan ; Li, Hua ; Gong, Lan ; Wu, Ling ; Xie, Bei ; Gao, Junwen ; Wang, Qi ; Liu, Zhihui ; Deng, Li ; Lei, Jie ; Huang, Bo

This study investigates the epidemic trend of pyrazinamide (PZA)-resistant tuberculosis in Southern China over 11 years (2012-2022) and evaluates the mutation characteristics of PZA resistance-related genes (pncA, rpsA, and panD) in clinical Mycobacterium tuberculosis (M. tuberculosis) isolates. To fulfil these goals, we analyzed the phenotypic PZA resistance characteristics of 14,927 clinical isolates for which Bactec MGIT 960 PZA drug susceptibility testing (DST) results were available, revealing that 2,054 (13.76%) isolates were resistant to PZA. After evaluating the annual variation in the PZA resistance rate among tuberculosis cases in this region, it was observed that it decreased from 37.21% to 6.45% throughout the initial 7 years (2012-2018) and then increased from 8.01% to 12.12% over the subsequent 4 years (2019-2022). Sequences of pncA were obtained from 402 clinical M. tuberculosis complex isolates. For rpsA and panD, sequences were obtained from 360 clinical M. tuberculosis complex isolates. Mutations in pncA were found in 8 out of 223 PZA-sensitive isolates (3.59%) and 105 of 179 (58.66%) PZA-resistant isolates. Conversely, non-synonymous mutations in rpsA were identified in 5 of 137 (3.65%) PZA-resistant isolates, whereas the mutation ratio of rpsA among PZA-sensitive isolates was high at 14.03% (31/221). This difference in the rpsA mutation rate was statistically significant (P = 0.001, chi-square test). No panD mutations were observed in the 137 PZA-resistant isolates, whereas two PZA-sensitive isolates harbored point mutations in panD, including one nonsense mutation (C433 T) and another C-69 T mutation. These findings indicate that rpsA and panD may not significantly contribute to the development of PZA resistance in clinical M. tuberculosis isolates.

01 Mar 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and validation of a liquid chromatography-tandem mass spectrometry assay for the simultaneous analysis of isoniazid and pyrazinamide in cerebrospinal fluid

Article

Author: Dooley, Kelly E ; Wiesner, Lubbe ; Joubert, Anton ; Wasserman, Sean ; van der Merwe, Marthinus ; Maputla, Sydwell Poulo ; Zangenberg, Edda ; Castel, Sandra

For the effective treatment of tuberculosis with first-line anti-tubercular drugs, drug concentrations need to be measured at the site of infection to determine drug exposure. To enable the measurement of the anti-tuberculosis drugs isoniazid and pyrazinamide in the nervous system of patients with tuberculous meningitis, an analytical method was developed and validated for the quantification of these drugs in human cerebrospinal fluid. Samples were prepared by solid phase extraction using Strata-X polymeric extraction plates. The analytes were separated by high-performance liquid chromatography on an Atlantis T3, 100 A, 3 µm, 2.1 mm × 100 mm analytical column with gradient elution, employing a mobile phase that consisted of acetonitrile-methanol-formic acid (50:50:0.1, v/v/v), at a flowrate of 0.25 mL/min. The total run time was 4.5 minutes, and the average retention times of isoniazid and pyrazinamide were 1.1 and 1.3 min, respectively. The analytes and their respective deuterated internal standards were detected on a Sciex API4000 triple quadrupole mass spectrometer applying positive electrospray ionization with multiple reaction monitoring as the detection mode. The method was validated according to the FDA and EMA guidelines. The method was demonstrated to be accurate, reproducible, and robust, showing the necessary sensitivity and specificity for the quantification of isoniazid and pyrazinamide in cerebrospinal fluid. The method was successfully applied to analyze clinical samples from the LASER-TBM and TBM-KIDS clinical studies.

01 Feb 2025·Pharmacogenetics and Genomics

Pharmacogenetics of tuberculosis treatment toxicity and effectiveness in a large Brazilian cohort

Article

Author: Turner, Megan ; Sterling, Timothy R ; Haas, David W ; Rolla, Valeria C ; Jaworski, James ; Cordeiro-Santos, Marcelo ; Figueiredo, Marina C ; Yang, Jing ; Amorim, Gustavo ; Santos, Adalberto R ; Velez Edwards, Digna R ; Kritski, Afrânio L ; Andrade, Bruno B

Background:

Genetic polymorphisms have been associated with risk of antituberculosis treatment toxicity. We characterized associations with adverse events and treatment failure/recurrence among adults treated for tuberculosis in Brazil.

Methods:

Participants were followed in Regional Prospective Observational Research in Tuberculosis (RePORT)-Brazil. We included persons with culture-confirmed drug-susceptible pulmonary tuberculosis who started treatment between 2015 and 2019, and who were eligible for pharmacogenetics. Treatment included 2 months of isoniazid, rifampin or rifabutin, pyrazinamide, and ethambutol, then 4 months of isoniazid and rifampin or rifabutin, with 24-month follow-up. Analyses included 43 polymorphisms in 20 genes related to antituberculosis drug hepatotoxicity or pharmacokinetics. Whole exome sequencing was done in a case-control toxicity subset.

Results:

Among 903 participants in multivariable genetic association analyses, NAT2 slow acetylator status was associated with increased risk of treatment-related grade 2 or greater adverse events, including hepatotoxicity. Treatment failure/recurrence was more likely among NAT2 rapid acetylators, but not statistically significant at the 5% level. A GSTM1 polymorphism (rs412543) was associated with increased risk of treatment-related adverse events, including hepatotoxicity. SLCO1B1 polymorphisms were associated with increased risk of treatment-related hepatoxicity and treatment failure/recurrence. Polymorphisms in NR1/2 were associated with decreased risk of adverse events and increased risk of failure/recurrence. In whole exome sequencing, hepatotoxicity was associated with a polymorphism in VTI1A, and the genes METTL17 and PRSS57, but none achieved genome-wide significance.

Conclusion:

In a clinical cohort representing three regions of Brazil, NAT2 acetylator status was associated with risk for treatment-related adverse events. Additional significant polymorphisms merit investigation in larger study populations, particularly regarding risk of treatment failure/recurrence.

News (Medical) associated with Pyrazinamide

01 Nov 2024

·www.tballiance.org

Introducing BPaL: Experiences from countries supported under the LIFT-TB project

11/2024 - PLoS One Author(s): D. F. Wares ,M. Mbenga ,V. Mirtskhulava ,M. Quelapio ,A. Slyzkyi ,I. Koppelaar ,S. N. Cho ,U. Go ,J. S. Lee ,J.-K. Jung ,D. Everitt ,S. Foraida ,M. Diachenko ,S. Juneja ,E. Burhan ,A. Totkogonova ,Z. Myint ,I. Flores ,N. A. Lytvynenko ,N. Parpieva ,N. V. Tags: BPaL, MDR-TB, Regimen Change 10/2024 Author(s): Denise Evans, Kamban Hirasen, Clive Ramushu, Lawrence Long, Edina Sinanovic, Francesca Conradie, Pauline Howell, Xavier Padanilam, Hannetjie Ferreira, Ebrahim Variaiva, Shakira Rajaram, Aastha Gupta, Sandeep Juneja, Norbert Ndjeka Tags: Bedaquiline (TMC-207), BPaL, Linezolid, Pretomanid/PA-824, TB Drug Market, TB Market 8/2024 - IJTLD Open Author(s): C. Auer, A. Gupta, C. Malbacius, A. Ghafoor, Y. Kock, O. Medvedieva, P. Hanlon, P. Steinmann, and S. Juneja Tags: BPaL, MDR-TB, TB Drug Market, TB Market 7/2024 - Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Author(s): B. Myrzaliev, M. Ahmatov, A. Duishekeeva, A. Kulzhabaeva, A. Kadyrov, A. Toktogonova, G. Abdulaeva, D.F. Wares , V. Mirtskhulava, M. Mbenga, A. Slyzkyi, S. Foraida, M. Diachenko, S. Juneja, G. Turdumambetova, A. Musaeva, A. Gebha Tags: Bedaquiline (TMC-207), BPaL, Linezolid, MDR-TB, Regimen Change, XDR-TB 6/2024 - The International Journal of Tuberculosis and Lung Disease Author(s): D. Evans, K. Hirasen, D.J. Casalme, M.T. Gler, A. Gupta, S. Juneja Tags: Bedaquiline (TMC-207), BPaL, Linezolid, Pretomanid/PA-824, Regimen Change, TB Drug Market 5/2024 - Lancet Infectious Diseases Author(s): Muge Cevik, MD Lindsay C Thompson, MPhil Caryn Upton, MD Valéria Cavalcanti Rolla Mookho Malahleha, MD Blandina Mmbaga, PhD Nosipho Ngubane, MD Zamzurina Abu Bakar, MD Mohammed Rassool, MD Ebrahim Variava, MD Rodney Dawson, MD Suzanne Staples, DPhil Umes Tags: Clinical Development, Clinical Trial Results, Global Pipeline, MDR-TB, Moxifloxacin, Pretomanid/PA-824, Pyrazinamide 5/2024 - Annals of Clinical Micobiology and Antimicrobials Author(s): Bing Zhao, Huiwen Zheng, Juliano Timm, Zexuan Song, Shaojun Pei, Ruida Xing, Yajie Guo, Ling Ma, Feina Li, Qing Li, Yan Li, Lin Huang, Chong Teng, Ni Wang, Aastha Gupta, Sandeep Juneja, Fei Huang, Yanlin Zhao, Xichao Ou Tags: Drug-Sensitivity Testing, M.tb. Biology, MDR-TB, Pretomanid/PA-824, XDR-TB 1/2024 - PLOS One Author(s): A Gupta, S Juneja, V Babawale, N R Majidovich, N Ndjeka, P T M Nguyen, P Nargiza Nusratovna, D R Omanito, T T Pakasi, Y Terleeva, A Toktogonova, Y Waheed, Z Myint, Z Yanlin, S Sahu Tags: Advocacy, Bedaquiline (TMC-207), BPaL, Linezolid, Moxifloxacin, Policy, Pretomanid/PA-824, TB Burden, TB Drug Market, TB Market 11/2023 - International Journal of Tuberculosis and Lung Disease Author(s): Taneja, R., Nahata, M. C., Scarim, J., Pande, P. G., Scarim, A., Hoddinott, G., Fourie, C. L., Jew, R. K., Schaaf, H. S., Hesseling, A. C., Garcia-Prats, A. J., Inabathina, K. Rao Tags: BENEFIT Kids, Underserved Populations 10/2023 - Clinical and Translational Science Author(s): Paloma Moraga, Paula Prieto, Almari Conradie, Majda Benhayoun, Vicki Rousell, Maria Davy, Uwe Fuhr, Rosa Antonijoan Arbos, Francisco Abad‐Santos, Antonio Portolés, Jolanda Van Duinen, Antonio J. Carcas, Alberto M. Borobia, and the ERA4TB Consortium Tags: Pharmacodynamics, Pharmacokinetics 10/2023 - Clinical Infectious Diseases Author(s): Tasnim Hasan, Ellie Medcalf, Bern-Thomas Nyang'wa, Erica Egizi, Catherine Berry, Matthew Dodd, Salah Foraida, Medea Gegia, Mengchun Li, Fuad Mirzayev, Hannah Morgan, Ilaria Motta, Linh Nguyen, Samuel Schumacher, Tim Schlub, Greg Fox Tags: Bedaquiline (TMC-207), BPaL, Linezolid, MDR-TB, Pretomanid/PA-824 10/2023 - PLOS Global Public Health Author(s): Juliano Timm, Anna Bateson, Priya Solanki, Ana Paleckyte, Adam A Witney, Sylvia A D Rofael, Stella Fabiane, Morounfolu Olugbosi, Timothy D McHugh, Eugene Sun Tags: Bedaquiline (TMC-207), BPaL, Linezolid, Pretomanid/PA-824 9/2023 - International Journal of Tuberculosis and Lung Disease Author(s): Viljoen, L., Acaba, J., Agbassi, Y. J. P., Beko, B., Goslett, C., Hoddinott, G., Kumar, B., Kumar, R. G., McKenna, L., Moses, G., Sachs, T., Seidel, S., von Delft, A. Tags: Advocacy, BENEFIT Kids, Underserved Populations 6/2023 - Indian Journal of Tuberculosis Author(s): Nibedita Rath, Chaitali Nikam, Stephanie Seidel, Anindya Sinha, Vijay Arora Tags: Advocacy, Community Engagement, TB Burden, Underserved Populations 5/2023 - Molecular Pharmaceutics Author(s): Hanh Thuy Nguyen, Tu Van Duong, Sarah Jaw-Tsai, Rebecca Bruning-Barry, Poonam Pande, Rajneesh Taneja, and Lynne S. Taylor Tags: Pretomanid/PA-824, TB Drug Market, Underserved Populations 3/2023 - International Journal of Tuberculosis and Lung Disease Author(s): R Taneja, M C Nahata, J Scarim, P G Pande, A Scarim, G Hoddinott, C L Fourie, R K Jew, H S Schaaf, A J Garcia-Prats, A C Hesseling Tags: Bedaquiline (TMC-207), BENEFIT Kids, Childhood TB, TB Burden, TB Market, Underserved Populations 3/2023 - Antimicrobial Agents and Chemotherapy Author(s): Si-Yang Li, Paul J. Converse, Fabrice Betoudji, Jin Lee, Khisimuzi Mdluli, Anna Upton, Nader Fotouhi, Eric L. Nuermberger Tags: Bedaquiline (TMC-207), BPaL, Clinical Development, Drug Discovery, Linezolid, Preclinical Data, Preclinical Models, Pretomanid/PA-824 3/2023 - International Journal of Infectious Diseases Author(s): Francesca Saluzzo, Juan Espinosa-Pereiro, Stephan Dressler, Ezio Tàvora Dos Santos Filho, Stephanie Seidel, Jesus Gonzalez Moreno, Norbert Heinrich, Adrian Sanchez-Montalva, Daniela Maria Cirillo Tags: Advocacy, Clinical Development, Community Engagement, Trial Design, Underserved Populations 2/2023 - International Journal of Tuberculosis and Lung Disease Author(s): Taneja, R., Nahata, M. C., Scarim, J., Pande, P. G., Scarim, A., Hoddinott, G., Fourie, C. L., Jew, R. K., Schaaf, H. S., Hesseling, A. C., Garcia-Prats, A. J. Tags: BENEFIT Kids, Childhood TB, Clofazamine, Underserved Populations 1/2023 - Journal of Biopharmaceutical Statistics Author(s): James Buchanana, Mengchun Lib, Barbara Hendricksonc, Parul Bhargavad, Satrajit Roychoudhury Tags: Trial Design

14 Feb 2024

·www.globenewswire.com

ACTG Announces Launch of Clinical Trial Evaluating Drug-Drug Interaction in Shortened Tuberculosis Regimen Among People Living with HIV

LOS ANGELES, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of study A5406 (Pharmacokinetics and Safety of Double-dose Dolutegravir When Used with Rifapentine for HIV-associated Tuberculosis). A5406 is a phase 2, open-label pharmacokinetic study investigating the effect that the anti-tuberculosis (TB) medication rifapentine has on levels of the HIV medication dolutegravir in the blood of participants who have HIV-associated TB and whether this combination can be safely and effectively used together. Previously, ACTG study A5349 demonstrated that a four-month, four-drug TB regimen that included high-dose rifapentine was as effective as the standard six-month regimen, cutting the treatment time by one third. Because other research has found that levels of dolutegravir (a recommended first-line HIV treatment) are reduced when given in combination with rifamycin drugs such as rifapentine, there is an urgent need to define the magnitude of the drug-drug interaction. “Understanding the relationship between these anti-TB and HIV medications is crucial, as an estimated one third of people living with HIV worldwide are at risk for developing TB,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. “We are hopeful that this study will answer these outstanding questions and thus provide a roadmap for treating HIV and TB together.” This single-arm, multicenter study will enroll 30 participants aged 18 years and older who are living with HIV, newly diagnosed with drug-sensitive TB, and not taking antiretroviral therapy (ART) at the time of their TB diagnosis. All participants will receive the following regimen: Daily high-dose rifapentine (1200 mg), moxifloxacin (400 mg), isoniazid (300 mg), and pyrazinamide (at standard doses adjusted for body weight) for eight weeks Followed by: Daily rifapentine (1200 mg), moxifloxacin (400 mg), and isoniazid (300 mg) for 9 weeks And: Dolutegravir-based ART twice daily, starting after six weeks of TB therapy Dolutegravir (50 mg) together with a fixed-dose combination of tenofovir disoproxil fumarate (300 mg) and lamivudine (300 mg), each morningDolutegravir (50 mg) until two weeks after completing TB treatment, each evening “While the shortened regimen is not yet part of routine care, it has been endorsed by health authorities as an equally effective and safe alternative to the standard six-month treatment,” said A5406 Protocol Chair Sean Wasserman, M.B.Ch.B., Ph.D., St George’s, University of London and the University of Cape Town. “We are hopeful that the results from A5406 will support the international roll-out of the shortened regimen, making it more accessible for those individuals at highest risk of TB.” A5406 will take place at four sites in Thailand and South Africa. It is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (which also funds the ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Dolutegravir is being supplied to study A5406 by ViiV Healthcare Ltd and the fixed-dose combination of dolutegravir/tenofovir disoproxil fumarate/lamivudine is being supplied by Viatris. A5406 is led by Dr. Wasserman and Richard E. Chaisson, M.D., Johns Hopkins University (Vice-chair). The ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice Chair). For more information about A5406, please visit clinicaltrials.gov. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, the ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at hundreds of locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of the ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

Phase 2

07 Dec 2023

·www.globenewswire.com

ACTG Announces Launch of Clinical Trial Evaluating Novel Treatment for Tuberculous Meningitis

Regimen Would Decrease Duration of Treatment from Nine to Six Months LOS ANGELES, Dec. 07, 2023 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of the IMAGINE-TBM study (Improved Management with Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM, also known as A5384). IMAGINE-TBM is a phase 2, randomized, open-label trial comparing a six-month regimen of high-dose rifampicin, high-dose isoniazid, linezolid, and pyrazinamide to the nine-month standard-of-care regimen for the treatment of tuberculous meningitis. Tuberculous meningitis is a life-threatening infectious disease that causes inflammation of the membranes that surround the brain and spinal cord. It is the most severe form of tuberculosis and is universally fatal when untreated. Even with standard-of-care treatment, outcomes are poor, with high rates of mortality and chronic disability among those who survive. While the global burden of tuberculous meningitis is unclear (due in large part to limited diagnostics), it is estimated to affect at least 100,000 people worldwide each year. “ACTG is especially excited about IMAGINE-TBM because it is an important step in addressing the paucity of data evaluating the best treatment approach for this devastating illness,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. “ACTG has designed this study with investigators from around the globe with the goal of evaluating the potential benefit of the new regimen in diverse settings.” This multi-center trial will enroll 330 participants aged 15 years and older who have definite, probable, or possible tuberculous meningitis, including people living with and without HIV. Participants will be randomized in equal proportions to receive either the six-month regimen being studied or the nine-month standard of care: Those in the six-month regimen arm will receive rifampicin 35 mg/kg, isoniazid 10-15 mg/kg, linezolid 1200 mg, and pyrazinamide 25 mg/kg for eight weeks followed by rifampicin 35 mg/kg and isoniazid 10 mg/kg for 16 weeks (for a total of 24 weeks of study treatment)Those in the nine-month standard-of-care regimen arm will receive rifampicin 10 mg/kg, isoniazid 5 mg/kg, ethambutol 20 mg/kg, and pyrazinamide 25 mg/kg for eight weeks, followed by rifampicin 10 mg/kg and isoniazid 5 mg/kg for 28 weeks (for a total of 36 weeks of study treatment). Up to 15 mg/kg or a maximum of 900 mg daily of oral rifampicin will be permitted at the clinician’s discretion. “IMAGINE-TBM is ACTG’s first tuberculous meningitis protocol and will take place in locations around the world that have a high tuberculosis burden,” said IMAGINE-TBM protocol Co-Chair Felicia Chow, M.D., M.A.S., University of California, San Francisco. “IMAGINE-TBM is a tremendous opportunity to leverage ACTG’s diverse international sites to test a novel intervention for this devastating form of TB.” IMAGINE-TB will take place at 17 sites in Peru, Tanzania, Thailand, Vietnam, Mexico, Philippines, India, Brazil, Zimbabwe, Kenya, Malawi, and South Africa. It is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. “Our hope is that this regimen will result in improved outcomes among individuals compared to the current standard of care, while significantly decreasing the required length of treatment,” said IMAGINE-TBM protocol Co-Chair Vidya Mave, M.D., M.P.H., Byramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site and Johns Hopkins Center for Infectious Diseases in India. “One of the top priorities for tuberculous meningitis research is optimizing treatment, which could have a profound impact on a population who has historically experienced abysmal outcomes.” IMAGINE-TBM is led by Drs. Chow and Mave and Kelly Dooley, M.D., Ph.D., Vanderbilt University (Vice-Chair). ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair). For more information about IMAGINE-TBM, please visit clinicaltrials.gov. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at hundreds of locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

Phase 2

100 Deals associated with Pyrazinamide

External Link

KEGG	Wiki	ATC	Drug Bank
D00144	Pyrazinamide	J04AK01	DB00339

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Tuberculosis	JP	Alfresa Pharma Corp.	20 Sep 1956

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02619994 (MDR-END, CTgov)	Phase 2	Tuberculosis, Multidrug-Resistant	214	Locally-used WHO-approved MDR-TB regimen in Korea (Control Arm)	wonxxehlvj(igyfgbvwbe) = ngxyhedlfx llodrpzzsr (xjhxngyddd, norzrwkvpo - ewdxtvxikg) View more	-	03 Jan 2025
				Levofloxacin+Linezolid+Delamanid+Pyrazinamide (Experimental Arm)	wonxxehlvj(igyfgbvwbe) = bpdprfrnlu llodrpzzsr (xjhxngyddd, tgediigqek - pqzwgydumv) View more
NCT03338621 (SimpliciTB, Pubmed \| Lancet Infect Dis)	Phase 2	Pulmonary Tuberculosis	455	Bedaquiline-pretomanid-moxifloxacin-pyrazinamide (BPaMZ) 4 months	anxkzwgqpl(arnpnwpwuc) = three participants [1%] ektfcbqsdw (ektxmhijhf ) View more	Positive	01 Sep 2024
NCT03882177 (StAT-TB, CTgov)	Phase 2	Pulmonary Tuberculosis	16	Vitamin B6+Pravastatin+Rifafour (Arm 1: Pravastatin (40 mg) and Rifafour)	mppwjovjdz(jbkwqhrueh) = yvsmowxkcv pnitozppxh (hnitoreifc, rjqwsznpwe - qtibqtmmol) View more	-	18 Sep 2023
				Vitamin B6+Pravastatin+Rifafour (Arm 2: Pravastatin (80 mg) and Rifafour)	mppwjovjdz(jbkwqhrueh) = auilluuicf pnitozppxh (hnitoreifc, xiuevrlhne - zkfjjhxdci) View more
NCT02256696 (CTgov)	Phase 2	Pulmonary Tuberculosis	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	nwgmyfdksu(yzfrtbcqbs) = tucftrphng jdswvgylzn (htiavgrepk, soidmbvptz - kwnzszossx) View more	-	18 Jul 2023
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	nwgmyfdksu(yzfrtbcqbs) = onjkeghhlw jdswvgylzn (htiavgrepk, bfxxgcilnm - wxpwbbzbgt) View more
NCT02554318 (FSS, CTgov)	Not Applicable	PULMONARY TUBERCULOSIS ACTIVE	147	Fermented soybean+Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Intervention)	aobzajeddf(thqlmljbcb) = dqlhvtriva xngemgszyv (kvektxnrwt, xfevpnlvhq - sbebnjswhw) View more	-	21 Jun 2022
				Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Control)	aobzajeddf(thqlmljbcb) = fibueqkyck xngemgszyv (kvektxnrwt, ypsyivbfvc - yqpiriogvb) View more
NCT01601626 (CTgov)	Phase 2	Tuberculosis \| HIV Infections	71	Standard-dose Lopinavir/Ritonavir+Ethambutol+Rifabutin+Pyridoxine+isoniazid+Pyrazinamide (A: Standard-dose LPV/r w/RBT)	tahhmtotpk(ddmpbdvcec) = ghsrxndkvh qmoyhfxacz (sqhesrzjlk, vjqaguzzsv - nrqzusgein) View more	-	13 Feb 2018
				Ethambutol+Rifampin+Pyridoxine+isoniazid+Double-dose Lopinavir/Ritonavir+Pyrazinamide (B: Double-dose LPV/r w/RIF)	tahhmtotpk(ddmpbdvcec) = rmoofoabwr qmoyhfxacz (sqhesrzjlk, vqurhgjyqc - wgpezhxscw) View more
NCT02700347 (Pubmed \| Antimicrob Agents Chemother)	Phase 1	Tuberculosis	12	PZA alone (10 mg/kg)	xfdhfdntko(owxlxixsbz) = vkpkfgnpja rcdenxexgj (mnnvdxiupu ) View more	-	01 Oct 2017
				PZA plus allopurinol (10 mg/kg)	xfdhfdntko(owxlxixsbz) = mdtujreuly rcdenxexgj (mnnvdxiupu ) View more
NCT00864383 (REMoxTB, CTgov)	Phase 3	Pulmonary Tuberculosis	1,931	Ethambutol+Rifampicin+Moxifloxacin+Isoniazid+Pyrazinamide (Regimen 1 - 2EHRZ/4HR (Control Regimen))	loqlgoceku(otforgsbyt) = tdrqtmeivu thnxmhipvi (rthdsdxyps, bbgydqtpdv - wsspgctkhz) View more	-	25 May 2015
				Ethambutol+Rifampicin+Moxifloxacin+Isoniazid+Pyrazinamide (Regimen 2 - 2MHRZ/2MHR)	loqlgoceku(otforgsbyt) = offjuilvvw thnxmhipvi (rthdsdxyps, cyntmqmffh - zxduyqcjal) View more
NCT00130247 (CTgov)	Phase 3	Pulmonary Tuberculosis	394	INH+ethambutol+rifampicin+pyrazinamide (4-Month Arm)	isjljhgypn(bhrcgrwokb) = gqthenbaal knjmuddriq (clbokjsywa, tzbjojhjle - vswyivcczt) View more	-	27 Jan 2010
				INH+ethambutol+rifampicin+pyrazinamide (6-Month Arm)	isjljhgypn(bhrcgrwokb) = ndcgvrytqo knjmuddriq (clbokjsywa, mhyvzspmjw - jeimghmenq) View more

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