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| ID | Type | Description | Link |
|---|---|---|---|
| PACTR2009060001493909 | Registry Identifier | www.pactr.org |
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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
| Sanofi | INDUSTRY |
| Kilimanjaro Christian Medical Centre, Tanzania | OTHER |
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In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of higher than standard doses rifampicin will be studied during the intensive phase of tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid, ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin plus the other drugs in standard dosages (third study arm). All patients will get the standard TB regimen during the continuation phase of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | 50 patients, treated with the standard anti-TB regimen, including rifampicin (600 mg), isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 2 placebo tablets resembling rifampicin 300 mg. |
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| 2 | Active Comparator | 50 patients, treated with rifampicin (900 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 1 placebo tablet resembling rifampicin 300 mg. |
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| 3 | Active Comparator | 50 patients, treated with rifampicin (1200 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin in higher doses | Drug | Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of rifampicin, desacetylrifampicin, isoniazid, pyrazinamide, ethambutol | Steady state, week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | baseline, week 1, 2, 4, 6, 8, 10, 12 | |
| Bacteriological response of Mycobacterium tuberculosis | Almost daily during first 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob Aarnoutse, Pharm-D, PhD | Radboud University Medical Center | Principal Investigator |
| Gibson Kibiki, MD, MMed, PhD | Kilimanjaro Christian Medical Centre,Moshi,Tanzania | Principal Investigator |
| Martin Boeree, MD PhD | Radboud University Nijmegen Medical Center/UCCZ Dekkerswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kibong'oto National Tuberculosis Hospital | Sanya Juu | Kilimanjaro | P.O. box 12 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13678977 | Background | Frieden TR, Sterling TR, Munsiff SS, Watt CJ, Dye C. Tuberculosis. Lancet. 2003 Sep 13;362(9387):887-99. doi: 10.1016/S0140-6736(03)14333-4. | |
| 12168751 | Background | Iseman MD. Tuberculosis therapy: past, present and future. Eur Respir J Suppl. 2002 Jul;36:87s-94s. doi: 10.1183/09031936.02.00309102. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania |
| UNKNOWN |
| University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands | UNKNOWN |
| National Institute for Public Health and the Environment (RIVM) | OTHER_GOV |
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| Compare accuracy of surrogate markers (SSCC, mRNA, cytokines) with standard two-month sputum conversion marker |
| Almost daily during first 8 weeks |
| Documenting the occurrence of mixed Mycobacterium tuberculosis strain infections | Almost daily during first 8 weeks |
| 17342142 | Background | Ginsberg AM, Spigelman M. Challenges in tuberculosis drug research and development. Nat Med. 2007 Mar;13(3):290-4. doi: 10.1038/nm0307-290. No abstract available. |
| 10985648 | Background | Mitchison DA. Role of individual drugs in the chemotherapy of tuberculosis. Int J Tuberc Lung Dis. 2000 Sep;4(9):796-806. |
| 17517849 | Background | Diacon AH, Patientia RF, Venter A, van Helden PD, Smith PJ, McIlleron H, Maritz JS, Donald PR. Early bactericidal activity of high-dose rifampin in patients with pulmonary tuberculosis evidenced by positive sputum smears. Antimicrob Agents Chemother. 2007 Aug;51(8):2994-6. doi: 10.1128/AAC.01474-06. Epub 2007 May 21. |
| 12821456 | Background | Jayaram R, Gaonkar S, Kaur P, Suresh BL, Mahesh BN, Jayashree R, Nandi V, Bharat S, Shandil RK, Kantharaj E, Balasubramanian V. Pharmacokinetics-pharmacodynamics of rifampin in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother. 2003 Jul;47(7):2118-24. doi: 10.1128/AAC.47.7.2118-2124.2003. |
| 1030315 | Background | Kreis B, Pretet S, Birenbaum J, Guibout P, Hazeman JJ, Orin E, Perdrizet S, Weil J. Two three-month treatment regimens for pulmonary tuberculosis. Bull Int Union Tuberc. 1976;51(1):71-5. No abstract available. |
| 110184 | Background | Long MW, Snider DE Jr, Farer LS. U.S. Public Health Service Cooperative trial of three rifampin-isoniazid regimens in treatment of pulmonary tuberculosis. Am Rev Respir Dis. 1979 Jun;119(6):879-94. doi: 10.1164/arrd.1979.119.6.879. |
| 11432536 | Background | Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001;40(5):327-41. doi: 10.2165/00003088-200140050-00002. |
| 17452486 | Background | Ruslami R, Nijland HM, Alisjahbana B, Parwati I, van Crevel R, Aarnoutse RE. Pharmacokinetics and tolerability of a higher rifampin dose versus the standard dose in pulmonary tuberculosis patients. Antimicrob Agents Chemother. 2007 Jul;51(7):2546-51. doi: 10.1128/AAC.01550-06. Epub 2007 Apr 23. |
| 16436757 | Background | Ruslami R, Nijland H, Aarnoutse R, Alisjahbana B, Soeroto AY, Ewalds S, van Crevel R. Evaluation of high- versus standard-dose rifampin in Indonesian patients with pulmonary tuberculosis. Antimicrob Agents Chemother. 2006 Feb;50(2):822-3. doi: 10.1128/AAC.50.2.822-823.2006. No abstract available. |
| 8540716 | Background | Solera J, Rodriguez-Zapata M, Geijo P, Largo J, Paulino J, Saez L, Martinez-Alfaro E, Sanchez L, Sepulveda MA, Ruiz-Ribo MD. Doxycycline-rifampin versus doxycycline-streptomycin in treatment of human brucellosis due to Brucella melitensis. The GECMEI Group. Grupo de Estudio de Castilla-la Mancha de Enfermedades Infecciosas. Antimicrob Agents Chemother. 1995 Sep;39(9):2061-7. doi: 10.1128/AAC.39.9.2061. |
| 11077029 | Background | Kochar DK, Aseri S, Sharma BV, Bumb RA, Mehta RD, Purohit SK. The role of rifampicin in the management of cutaneous leishmaniasis. QJM. 2000 Nov;93(11):733-7. doi: 10.1093/qjmed/93.11.733. |
| 16574936 | Background | Rosenthal IM, Williams K, Tyagi S, Peloquin CA, Vernon AA, Bishai WR, Grosset JH, Nuermberger EL. Potent twice-weekly rifapentine-containing regimens in murine tuberculosis. Am J Respir Crit Care Med. 2006 Jul 1;174(1):94-101. doi: 10.1164/rccm.200602-280OC. Epub 2006 Mar 30. |
| 10529902 | Background | 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 Oct;3(10 Suppl 2):S231-79. No abstract available. |
| 9925057 | Background | Peloquin CA, Namdar R, Singleton MD, Nix DE. Pharmacokinetics of rifampin under fasting conditions, with food, and with antacids. Chest. 1999 Jan;115(1):12-8. doi: 10.1378/chest.115.1.12. |
| 16028152 | Background | Tappero JW, Bradford WZ, Agerton TB, Hopewell P, Reingold AL, Lockman S, Oyewo A, Talbot EA, Kenyon TA, Moeti TL, Moffat HJ, Peloquin CA. Serum concentrations of antimycobacterial drugs in patients with pulmonary tuberculosis in Botswana. Clin Infect Dis. 2005 Aug 15;41(4):461-9. doi: 10.1086/431984. Epub 2005 Jul 8. |
| 6356277 | Background | Grosset J, Leventis S. Adverse effects of rifampin. Rev Infect Dis. 1983 Jul-Aug;5 Suppl 3:S440-50. doi: 10.1093/clinids/5.supplement_3.s440. |
| 11737875 | Background | Brindle R, Odhiambo J, Mitchison D. Serial counts of Mycobacterium tuberculosis in sputum as surrogate markers of the sterilising activity of rifampicin and pyrazinamide in treating pulmonary tuberculosis. BMC Pulm Med. 2001;1:2. doi: 10.1186/1471-2466-1-2. |
| 8466107 | Background | Mitchison DA. Assessment of new sterilizing drugs for treating pulmonary tuberculosis by culture at 2 months. Am Rev Respir Dis. 1993 Apr;147(4):1062-3. doi: 10.1164/ajrccm/147.4.1062. No abstract available. |
| 8972122 | Background | Mitchison DA. Modern methods for assessing the drugs used in the chemotherapy of mycobacterial disease. Soc Appl Bacteriol Symp Ser. 1996;25:72S-80S. No abstract available. |
| 6774638 | Background | Jindani A, Aber VR, Edwards EA, Mitchison DA. The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis. 1980 Jun;121(6):939-49. doi: 10.1164/arrd.1980.121.6.939. No abstract available. |
| 10764293 | Background | Wallis RS, Perkins MD, Phillips M, Joloba M, Namale A, Johnson JL, Whalen CC, Teixeira L, Demchuk B, Dietze R, Mugerwa RD, Eisenach K, Ellner JJ. Predicting the outcome of therapy for pulmonary tuberculosis. Am J Respir Crit Care Med. 2000 Apr;161(4 Pt 1):1076-80. doi: 10.1164/ajrccm.161.4.9903087. |
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| 9310014 | Background | Hafner R, Cohn JA, Wright DJ, Dunlap NE, Egorin MJ, Enama ME, Muth K, Peloquin CA, Mor N, Heifets LB. Early bactericidal activity of isoniazid in pulmonary tuberculosis. Optimization of methodology. The DATRI 008 Study Group. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):918-23. doi: 10.1164/ajrccm.156.3.9612016. |
| 10390401 | Background | Desjardin LE, Perkins MD, Wolski K, Haun S, Teixeira L, Chen Y, Johnson JL, Ellner JJ, Dietze R, Bates J, Cave MD, Eisenach KD. Measurement of sputum Mycobacterium tuberculosis messenger RNA as a surrogate for response to chemotherapy. Am J Respir Crit Care Med. 1999 Jul;160(1):203-10. doi: 10.1164/ajrccm.160.1.9811006. |
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| 12093679 | Background | Ribeiro-Rodrigues R, Resende Co T, Johnson JL, Ribeiro F, Palaci M, Sa RT, Maciel EL, Pereira Lima FE, Dettoni V, Toossi Z, Boom WH, Dietze R, Ellner JJ, Hirsch CS. Sputum cytokine levels in patients with pulmonary tuberculosis as early markers of mycobacterial clearance. Clin Diagn Lab Immunol. 2002 Jul;9(4):818-23. doi: 10.1128/cdli.9.4.818-823.2002. |
| 16367947 | Background | Quaedvlieg V, Henket M, Sele J, Louis R. Cytokine production from sputum cells in eosinophilic versus non-eosinophilic asthmatics. Clin Exp Immunol. 2006 Jan;143(1):161-6. doi: 10.1111/j.1365-2249.2005.02968.x. |
| 15858808 | Background | Colombo C, Costantini D, Rocchi A, Cariani L, Garlaschi ML, Tirelli S, Calori G, Copreni E, Conese M. Cytokine levels in sputum of cystic fibrosis patients before and after antibiotic therapy. Pediatr Pulmonol. 2005 Jul;40(1):15-21. doi: 10.1002/ppul.20237. |
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| 28827417 | Derived | Aarnoutse RE, Kibiki GS, Reither K, Semvua HH, Haraka F, Mtabho CM, Mpagama SG, van den Boogaard J, Sumari-de Boer IM, Magis-Escurra C, Wattenberg M, Logger JGM, Te Brake LHM, Hoelscher M, Gillespie SH, Colbers A, Phillips PPJ, Plemper van Balen G, Boeree MJ; PanACEA Consortium. Pharmacokinetics, Tolerability, and Bacteriological Response of Rifampin Administered at 600, 900, and 1,200 Milligrams Daily in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e01054-17. doi: 10.1128/AAC.01054-17. Print 2017 Nov. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |