A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis

PLoS ONE

Volumn 11, Issue 5, 2016, Pages

  Conde, Marcus B ^a   Mello, Fernanda C Q ^a   Duarte, Rafael Silva ^a   Cavalcante, Solange C ^b,c   Rolla, Valeria ^c   Dalcolmo, Margareth ^d   Loredo, Carla ^a   Durovni, Betina ^b   Armstrong, Derek T ^e   Efron, Anne ^e   Barnes, Grace L ^e   Marzinke, Mark A ^e   Savic, Radojka M ^f   Dooley, Kelly E ^e   Cohn, Silvia ^e   Moulton, Lawrence H ^g   Chaisson, Richard E ^e   Dorman, Susan E ^e  

^a FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

^b Municipal Health Secretariat   (Brazil)

^c Funda??o Oswaldo Cruz   (Brazil)

^d INSTITUTO OSWALDO CRUZ   (Brazil)

^e JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETHAMBUTOL; ISONIAZID; MOXIFLOXACIN; PYRAZINAMIDE; RIFAMPICIN; RIFAPENTINE; QUINOLONE DERIVATIVE; TUBERCULOSTATIC AGENT;

ADULT; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BACTERICIDAL ACTIVITY; CONTROLLED STUDY; DIRECTLY OBSERVED THERAPY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EYE REFRACTION; FEMALE; FLU LIKE SYNDROME; HUMAN; LIVER TOXICITY; LOW DRUG DOSE; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SPUTUM CULTURE; UNSPECIFIED SIDE EFFECT; ANALOGS AND DERIVATIVES; CASE CONTROL STUDY; CLINICAL TRIAL; COMBINATION DRUG THERAPY; MIDDLE AGED; TUBERCULOSIS, PULMONARY;

ADULT; ANTITUBERCULAR AGENTS; CASE-CONTROL STUDIES; DRUG THERAPY, COMBINATION; FEMALE; FLUOROQUINOLONES; HUMANS; ISONIAZID; MALE; MIDDLE AGED; PYRAZINAMIDE; RIFAMPIN; TUBERCULOSIS, PULMONARY;

EID: 84969769848     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0154778     Document Type: Article

References (38)

1. Abu-Raddad LJ, Sabatelli L, Achterberg JT, Sugimoto JD, Longini IM Jr., Dye C, et al. Epidemiological benefits of more-effective tuberculosis vaccines, drugs, and diagnostics. Proc Natl Acad Sci U S A. 2009; 106:13980-5. doi: 10.1073/pnas.0901720106 PMID: 19666590
2. Grosset J. Bacteriologic basis of short-course chemotherapy for tuberculosis. Clin. Chest Med. 1980; 1:231-41. PMID: 6794976
3. Mitchison DA. Role of individual drugs in the chemotherapy of tuberculosis. Int. J. Tuberc. Lung Dis. 2000; 4:796-806. PMID: 10985648
4. Jayaram R, Gaonkar S, Kaur P, Suresh BL, Mahesh BN, Jayashree R, et al. Pharmacokinetics-pharmacodynamics of rifampin in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother 2003; 47:2118-24. PMID: 12821456
5. Ji B, Truffot-Pernot C, Lacroix C, Raviglione MC, O'Brien RJ, Olliaro P, et al. Effectiveness of rifampin, rifabutin and rifapentine for preventive therapy of tuberculosis in mice. Am Rev Respir Dis. 1993; 148:1541-6. PMID: 8256897
6. Long M, Snider D, Farer L. US Public Health Service cooperative trial of three rifampicin-isoniazid regimens in treatment of pulmonary tuberculosis. Am Rev Respir Dis 1979; 119:879-94. PMID: 110184
7. Jindani A, Aber V, Edwards E, Mitchison D. The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis 1980; 121:939-49. PMID: 6774638
8. Sirgel FA, Fourie PB, Donald PR, Padayatchi N, Rustomjee R, Levin J, et al. The early bactericidal activities of rifampin and rifapentine in pulmonary tuberculosis. Am J Respir Crit Care Med 2005; 172:128-35. PMID: 15805182
9. Diacon A, Patientia R, Venter A, van Helden PD, Smith PJ, McIlleron H, et al. Early bactericidal activity of high-dose rifampin in patients with pulmonary tuberculosis evidenced by positive sputum smears. Antimicrob Agents Chemother 2007; 51:2994-6. PMID: 17517849
10. Heifets LB, Lindholm-Levy PJ, Flory MA. Bactericidal activity in vitro of various rifamycins against Mycobacterium avium and Mycobacterium tuberculosis. Am Rev Respir Dis 1990; 141:626-30. PMID: 2155555
11. Keung A, Eller MG, McKenzie KA, Weir SJ. Single and multiple dose pharmacokinetics of rifapentine in man: Part II. Int J Tuberc Lung Dis 1999; 3:437-44. PMID: 10331734
12. Langdon G, Wilkins JJ, Smith PJ, McIlleron H. Consecutive-dose pharmacokinetics of rifapentine in patients diagnosed with pulmonary tuberculosis. Int J Tuberc Lung Dis 2004; 8:862-7. PMID: 15260278
13. Bemer-Melchior P, Bryskier A, Drugeon HB. Comparison of the in vitro activities of rifapentine and rifampicin against Mycobacterium tuberculosis complex. J Antimicrob Chemother 2000; 46:571-6. PMID: 11020254
14. Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001; 40(5):327-41. PMID: 11432536
15. Rosenthal IM, Zhang M, Williams KN, Peloquin CA, Tyagi S, Vernon AA, et al. Daily dosing of rifapentine cures tuberculosis in three months or less in the murine model. PLoS Med. 2007 4(12):e344. PMID: 18092886
16. Rosenthal IM, Zhang M, Almeida D, Grosset JH, Nuermberger EL. Isoniazid or moxifloxacin in rifapentine-based regimens for experimental tuberculosis? Am J Respir Crit Care Med 2008; 178:989-93. doi: 10.1164/rccm.200807-1029OC PMID: 18723432
17. Rosenthal IM, Tasneen R, Peloquin CA, Zhang M, Almeida D, Mdluli KE, et al. Dose-ranging comparison of rifampin and rifapentine in two pathologically distinct murine models of tuberculosis. Antimicrob Agents Chemother. 2012; 56:4331-40. doi: 10.1128/AAC.00912-12 PMID: 22664964
18. Gillespie SH, Billington O. Activity of moxifloxacin against mycobacteria. J Antimicrob Chemother. 1999; 44:393-5. PMID: 10511409
19. Miyazaki E, Miyazaki M, Chen JM, Chaisson RE, Bishai WR. Moxifloxacin (BAY12-8039), a new 8-methoxyquinolone, is active in a mouse model of tuberculosis. Antimicrob Agents Chemother 1999; 43:85-9. PMID: 9869570
20. Nuermberger EL, Yoshimatsu T, Tyagi S, O'Brien RJ, Vernon AN, Chaisson RE, et al. Moxifloxacin-containing regimen greatly reduces time to culture conversion in murine tuberculosis. Am J Respir Crit Care Med 2004; 169:421-6. PMID: 14578218
21. Nuermberger EL, Yoshimatsu T, Tyagi S, Williams K, Rosenthal I, O'Brien RJ, et al. Moxifloxacin-containing regimens of reduced duration produce a stable cure in murine tuberculosis. Am J Respir Crit Care Med 2004; 170:1131-4. PMID: 15306535
22. Rustomjee R, Lienhardt C, Kanyok T, Davies GR, Levin J, Mthiyane T, et al. A phase II study of the sterilising activities of ofloxacin, gatifloxacin, and moxifloxacin in pulmonary tuberculosis. Int J Tuberc Lung Dis 2008; 12:128-38. PMID: 18230244
23. Conde MB, Efron A, Loredo C, De Souza GR, Graca NP, Cezar MC, et al. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial. Lancet 2009; 373:1183-9. doi: 10.1016/S0140-6736(09)60333-0 PMID: 19345831
24. Gillespie SH, Crook AM, McHugh TD, Mendel CM, Meredith SK, Murray SR, et al. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. New Engl J Med 2014; 371:1577-87. doi: 10.1056/NEJMoa1407426 PMID: 25196020
25. Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, et al. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med. 2003; 167:603-62. PMID: 12588714
26. Peloquin CA, Namdar R, Singleton MD, Nix DE. Pharmacokinetics of rifampin under fasting conditions, with food, and with antacids. Chest 1999; 115:12-18. PMID: 9925057
27. Zvada SP, Van Der Walt JS, Smith PJ, Fourie PB, Roscigno G, Mitchison D, et al. Effect of four different meal types on the population pharmacokinetics of single dose rifapentine in healthy male volunteers. Antimicrob Agents Chemother. 2010; 54:3390-4. doi: 10.1128/AAC.00345-10 PMID: 20516273
28. Dooley KE, Savic RM, Park JG, Cramer Y, Hafner R, Hogg E, et al. Novel dosing strategies increase exposures of the potent antituberculosis drug rifapentine but are poorly tolerated in healthy volunteers. Antimicrob Agents Chemother. 2015; 59:3399-405. doi: 10.1128/AAC.05128-14 PMID: 25824215
29. Fox W, Ellard GA, Mitchison DA. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council tuberculosis units, 1946-1986, with relevant subsequent publications. Int J Tuberc Lung Dis 1999; 3:S231-79. PMID: 10529902
30. Dorman SE, Savic RM, Goldberg S, Stout JE, Schluger N, Muzanyi G, et al. Daily rifapentine for treatment of pulmonary tuberculosis. A randomized, dose-ranging trial. Am J Respir Crit Care Med 2015; 191:333-43. doi: 10.1164/rccm.201410-1843OC PMID: 25489785
31. Dawson R, Narunsky K, Carman D, Gupte N, Whitelaw A, Efron A, et al. Two-stage activity-safety study of daily rifapentine during intensive phase treatment of pulmonary tuberculosis. Int J Tuberc Lung Dis 2015; 19:780-6.
32. Jindani A, Harrison TS, Nunn AJ, Phillips PP, Churchyard GJ, Charalambous S, et al. High-dose rifapentine with moxifloxacin for pulmonary tuberculosis. N Engl J Med 2014;371:1599-1608. doi: 10.5588/ijtld.14.0868 PMID: 26056101
33. Jindani A, Harrison TS, Nunn AJ, Phillips PP, Churchyard GJ, Charalambous S, et al. High-dose rifapentine with moxifloxacin for pulmonary tuberculosis. N Engl J Med 2014; 371:1599-1608. doi: 10.1056/NEJMoa1314210 PMID: 25337749
34. Kjellsson MC, Via LE, Goh A, Weiner D, Low KM, Kern S, et al. Pharmacokinetic evaluation of the penetration of antituberculosis agents in rabbit pulmonary lesions. Antimicrob Agents Chemother 2012; 56:446-57. doi: 10.1128/AAC.05208-11 PMID: 21986820
35. Zvada SP, Denti P, Geldenhuys H, Meredith S, van As D, Hatherill M, Hanekom W, Wiesner L, Simonsson US, Jindani A, Harrison T, McIlleron HM. Moxifloxacin population pharmacokinetics in patients with pulmonary tuberculosis and the effect of intermittent high-dose rifapentine. Antimicrob Agents Chemother 2012; 56:4471-3. doi: 10.1128/AAC.00404-12 PMID: 22585223
36. Dooley K, Flexner C, Hackman J, Peloquin CA, Nuermberger E, Chaisson RE, Dorman SE. Repeated administration of high-dose intermittent rifapentine reduces rifapentine and moxifloxacin plasma concentrations. Antimicrob Agents Chemother 2008; 52:4037-42. doi: 10.1128/AAC.00554-08 PMID: 18765687
37. Dorman SE, Goldberg S, Stout JE, Muzanyi G, Johnson JL, Weiner M, et al. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the Tuberculosis Trials Consortium. J Infect Dis 2012; 206:1030-40. PMID: 22850121
38. Sterling TR, Moro RN, Borisov AS, Phillips E, Shepherd G, Adkinson NF, et al. Flu-like and other systemic drug reactions among persons receiving weekly rifapentine plus isoniazid or daily isoniazid for treatment of latent tuberculosis infection in the PREVENT tuberculosis study. Clin Infect Dis 2015;15:527-35.