Dynamic imaging in patients with tuberculosis reveals heterogeneous drug exposures in pulmonary lesions.
Adult
Animals
Antitubercular Agents
/ administration & dosage
Biological Availability
Drug Therapy, Combination
Female
Humans
Lung
/ diagnostic imaging
Male
Mycobacterium tuberculosis
/ physiology
Positron Emission Tomography Computed Tomography
Rabbits
Rifampin
/ administration & dosage
Tissue Distribution
Tuberculosis
/ diagnosis
Tuberculosis, Pulmonary
/ diagnosis
Journal
Nature medicine
ISSN: 1546-170X
Titre abrégé: Nat Med
Pays: United States
ID NLM: 9502015
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
19
08
2019
accepted:
15
01
2020
pubmed:
19
2
2020
medline:
23
7
2020
entrez:
19
2
2020
Statut:
ppublish
Résumé
Tuberculosis (TB) is the leading cause of death from a single infectious agent, requiring at least 6 months of multidrug treatment to achieve cure
Identifiants
pubmed: 32066976
doi: 10.1038/s41591-020-0770-2
pii: 10.1038/s41591-020-0770-2
pmc: PMC7160048
mid: NIHMS1564768
doi:
Substances chimiques
Antitubercular Agents
0
Rifampin
VJT6J7R4TR
Types de publication
Clinical Study
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
529-534Subventions
Organisme : NIAID NIH HHS
ID : K08 AI139371
Pays : United States
Organisme : NIBIB NIH HHS
ID : R01 EB020539
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL131829
Pays : United States
Organisme : NIAID NIH HHS
ID : R56 AI145435
Pays : United States
Références
World Health Organization. Global Tuberculosis Report 2019 (World Health Organization, 2019).
Reynolds, J. & Heysell, S. K. Understanding pharmacokinetics to improve tuberculosis treatment outcome. Expert Opin. Drug Metab. Toxicol. 10, 813–823 (2014).
pubmed: 24597717
pmcid: 4112565
DeMarco, V. P. et al. Determination of [
pubmed: 26169396
pmcid: 4538528
Tucker, E. W. et al. Noninvasive
pubmed: 30518610
pmcid: 6360528
Diacon, A. H. et al. Early bactericidal activity of high-dose rifampin in patients with pulmonary tuberculosis evidenced by positive sputum smears. Antimicrob. Agents Chemother. 51, 2994–2996 (2007).
pubmed: 17517849
pmcid: 1932511
Chigutsa, E. et al. Impact of nonlinear interactions of pharmacokinetics and MICs on sputum bacillary kill rates as a marker of sterilizing effect in tuberculosis. Antimicrob. Agents Chemother. 59, 38–45 (2015).
pubmed: 25313213
Pasipanodya, J. G. et al. Serum drug concentrations predictive of pulmonary tuberculosis outcomes. J. Infect. Dis. 208, 1464–1473 (2013).
pubmed: 23901086
pmcid: 3789573
Swaminathan, S. et al. Drug concentration thresholds predictive of therapy failure and death in children with tuberculosis: bread crumb trails in random forests. Clin. Infect. Dis. 63, S63–S74 (2016).
pubmed: 27742636
pmcid: 5064152
Grobbelaar, M. et al. Evolution of rifampicin treatment for tuberculosis. Infect. Genet. Evol. 74, 103937 (2019).
pubmed: 31247337
Boeree, M. J. et al. High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis: a multi-arm, multi-stage randomised controlled trial. Lancet Infect. Dis. 17, 39–49 (2017).
pubmed: 28100438
pmcid: 5159618
Svensson, R. J. et al. Greater early bactericidal activity at higher rifampicin doses revealed by modeling and clinical trial simulations. J. Infect. Dis. 218, 991–999 (2018).
pubmed: 29718390
Pasipanodya, J. G. et al. Artificial intelligence-derived 3-way concentration-dependent antagonism of gatifloxacin, pyrazinamide, and rifampicin during treatment of pulmonary tuberculosis. Clin. Infect. Dis. 67, S284–S292 (2018).
pubmed: 30496458
pmcid: 6904294
Ehrlich, P. Address in pathology on chemotherapeutics: scientific principles, methods, and results. Lancet 182, 445–451 (1913).
Velasquez, G. E. et al. Efficacy and safety of high-dose rifampin in pulmonary tuberculosis: a randomized controlled trial. Am. J. Respir. Crit. Care Med. 198, 657–666 (2018).
pubmed: 29954183
pmcid: 6118011
Aarnoutse, R. E. et al. Pharmacokinetics, tolerability, and bacteriological response of rifampin administered at 600, 900, and 1,200 milligrams daily in patients with pulmonary tuberculosis. Antimicrob. Agents Chemother. 61, e01054-17 (2017).
pubmed: 28827417
pmcid: 5655063
Peloquin, C. A. et al. Pharmacokinetic evidence from the HIRIF trial to support increased doses of rifampin for tuberculosis. Antimicrob. Agents Chemother. 61, e01054-17 (2017).
Te Brake, L. H. M., Boeree, M. J. & Aarnoutse, R. E. Conflicting findings on an intermediate dose of rifampicin for pulmonary tuberculosis. Am. J. Respir. Crit. Care Med. 199, 1166–1167 (2019).
Dorman, S. E. et al. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the Tuberculosis Trials Consortium. J. Infect. Dis. 206, 1030–1040 (2012).
pubmed: 22850121
Prideaux, B. et al. The association between sterilizing activity and drug distribution into tuberculosis lesions. Nat. Med. 21, 1223–1227 (2015).
pubmed: 26343800
pmcid: 4598290
Dheda, K. et al. Drug-penetration gradients associated with acquired drug resistance in patients with tuberculosis. Am. J. Respir. Crit. Care Med. 198, 1208–1219 (2018).
pubmed: 29877726
pmcid: 6221573
Hunter, R. L. The pathogenesis of tuberculosis: the early infiltrate of post-primary (adult pulmonary) tuberculosis: a distinct disease entity. Front. Immunol. 9, 2108 (2018).
pubmed: 30283448
pmcid: 6156532
Jain, S. K. et al. Tuberculous meningitis: a roadmap for advancing basic and translational research. Nat. Immunol. 19, 521–525 (2018).
pubmed: 29777209
pmcid: 6089350
Pan, H. et al. Ipr1 gene mediates innate immunity to tuberculosis. Nature 434, 767–772 (2005).
pubmed: 15815631
pmcid: 1388092
Nau, R. et al. Penetration of rifampicin into the cerebrospinal fluid of adults with uninflamed meninges. J. Antimicrob. Chemother. 29, 719–724 (1992).
pubmed: 1506352
Urbanowski, M. E. et al. Repetitive aerosol exposure promotes cavitary tuberculosis and enables screening for targeted inhibitors of extensive lung destruction. J. Infect. Dis. 218, 53–63 (2018).
pubmed: 29554286
pmcid: 5989619
Canetti, G. Present aspects of bacterial resistance in tuberculosis. Am. Rev. Respir. Dis. 92, 687–703 (1965).
pubmed: 5321145
Benator, D. et al. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomised clinical trial. Lancet 360, 528–534 (2002).
pubmed: 12241657
Kjellsson, M. C. et al. Pharmacokinetic evaluation of the penetration of antituberculosis agents in rabbit pulmonary lesions. Antimicrob. Agents Chemother. 56, 446–457 (2012).
pubmed: 21986820
pmcid: 3256032
Rifat, D. et al. Pharmacokinetics of rifapentine and rifampin in a rabbit model of tuberculosis and correlation with clinical trial data. Sci. Transl. Med. 10, eaai7786 (2018).
pubmed: 29618565
pmcid: 5969904
Le Guellec, C., Gaudet, M. L., Lamanetre, S. & Breteau, M. Stability of rifampin in plasma: consequences for therapeutic monitoring and pharmacokinetic studies. Ther. Drug Monit. 19, 669–674 (1997).
pubmed: 9421109
Samara, E. et al. Antibiotic stability over six weeks in aqueous solution at body temperature with and without heat treatment that mimics the curing of bone cement. Bone Joint Res. 6, 296–306 (2017).
pubmed: 28515059
pmcid: 5457644
Magombedze, G. et al. Transformation morphisms and time-to-extinction analysis that map therapy duration from preclinical models to patients with tuberculosis: translating from apples to oranges. Clin. Infect. Dis. 67, S349–S358 (2018).
pubmed: 30496464
pmcid: 6260172
Lappin, G., Noveck, R. & Burt, T. Microdosing and drug development: past, present and future. Expert Opin. Drug Metab. Toxicol. 9, 817–834 (2013).
pubmed: 23550938
pmcid: 4532546
Nix, D. E., Goodwin, S. D., Peloquin, C. A., Rotella, D. L. & Schentag, J. J. Antibiotic tissue penetration and its relevance: impact of tissue penetration on infection response. Antimicrob. Agents Chemother. 35, 1953–1959 (1991).
pubmed: 1759813
pmcid: 245307
Liu, L. et al. Radiosynthesis and bioimaging of the tuberculosis chemotherapeutics isoniazid, rifampicin and pyrazinamide in baboons. J. Med. Chem. 53, 2882–2891 (2010).
pubmed: 20205479
pmcid: 2866172
Ordonez, A. A. et al. Molecular imaging of bacterial infections: overcoming the barriers to clinical translation. Sci. Transl. Med. 11, eaax8251 (2019).
pubmed: 31484790
Rubinstein, L. V. et al. The statistics of phase 0 trials. Stat. Med. 29, 1072–1076 (2010).
pubmed: 20419759
pmcid: 3902019
Ordonez, A. A. et al. Radiosynthesis and PET bioimaging of
pubmed: 31345032
US Food and Drug Administration. Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies (US Food and Drug Administration, 2006).
US Food and Drug Administration. Guidance for Industry and Researchers: The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application (US Food and Drug Administration, 2010).
US Food and Drug Administration. Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (Center for Drug Evaluation and Research, 2005).
Hedlund, L. W., Vock, P. & Effmann, E. L. Evaluating lung density by computed tomography. Semin. Respir. Crit. Care Med. 5, 76–88 (1983).
Smythe, W. et al. A semimechanistic pharmacokinetic-enzyme turnover model for rifampin autoinduction in adult tuberculosis patients. Antimicrob. Agents Chemother. 56, 2091–2098 (2012).
pubmed: 22252827
pmcid: 3318330
Wagner, C. C. & Langer, O. Approaches using molecular imaging technology—use of PET in clinical microdose studies. Adv. Drug Deliv. Rev. 63, 539–546 (2011).
pubmed: 20887762
Svensson, R. J. et al. A population pharmacokinetic model incorporating saturable pharmacokinetics and autoinduction for high rifampicin doses. Clin. Pharmacol. Ther. 103, 674–683 (2018).
pubmed: 28653479
Acocella, G., Bonollo, L., Mainardi, M., Margaroli, P. & Tenconi, L. Serum and urine concentrations of rifampicin administered by intravenous infusion in man. Arzneimittelforschung 27, 1221–1226 (1977).
pubmed: 578447
Nitti, V., Virgilio, R., Patricolo, M. & Iuliano, A. Pharmacokinetic study of intravenous rifampicin. Chemotherapy 23, 1–6 (1977).
pubmed: 832508
Loos, U. et al. Pharmacokinetics of oral and intravenous rifampicin during chronic administration. Klin. Wochenschr. 63, 1205–1211 (1985).
pubmed: 4087830
Boeree, M. J. et al. A dose-ranging trial to optimize the dose of rifampin in the treatment of tuberculosis. Am. J. Respir. Crit. Care Med. 191, 1058–1065 (2015).
pubmed: 25654354
Gumbo, T., Pasipanodya, J. G., Romero, K., Hanna, D. & Nuermberger, E. Forecasting accuracy of the hollow fiber model of tuberculosis for clinical therapeutic outcomes. Clin. Infect. Dis. 61 (Suppl. 1), S25–S31 (2015).
pubmed: 26224769