Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients.
<h4>Background</h4>Shortening tuberculosis (TB) treatment duration is a research priority. This paper presents data from a prematurely terminated randomized clinical trial, of 4-month moxifloxacin or gatifloxacin regimens, in South India.<h4>Methods</h4>Newly diagnosed, sputu...
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| author | Mohideen S Jawahar Vaithilingam V Banurekha Chinnampedu N Paramasivan Fathima Rahman Rajeswari Ramachandran Perumal Venkatesan Rani Balasubramanian Nagamiah Selvakumar Chinnaiyan Ponnuraja Allaudeen S Iliayas Navaneethapandian P Gangadevi Balambal Raman Dhanaraj Baskaran Santhanakrishnan R Kumar Marimuthu M Kumar Victor Mohan Sudha Ganapathy Vanaja Kumar Geetha Shanmugam Niruparani Charles Murugesan R Sakthivel Kannivelu Jagannath Chockalingam Chandrasekar Ramavaram T Parthasarathy Paranji R Narayanan |
| author_facet | Mohideen S Jawahar Vaithilingam V Banurekha Chinnampedu N Paramasivan Fathima Rahman Rajeswari Ramachandran Perumal Venkatesan Rani Balasubramanian Nagamiah Selvakumar Chinnaiyan Ponnuraja Allaudeen S Iliayas Navaneethapandian P Gangadevi Balambal Raman Dhanaraj Baskaran Santhanakrishnan R Kumar Marimuthu M Kumar Victor Mohan Sudha Ganapathy Vanaja Kumar Geetha Shanmugam Niruparani Charles Murugesan R Sakthivel Kannivelu Jagannath Chockalingam Chandrasekar Ramavaram T Parthasarathy Paranji R Narayanan |
| author_sort | Mohideen S Jawahar |
| collection | DOAJ |
| description | <h4>Background</h4>Shortening tuberculosis (TB) treatment duration is a research priority. This paper presents data from a prematurely terminated randomized clinical trial, of 4-month moxifloxacin or gatifloxacin regimens, in South India.<h4>Methods</h4>Newly diagnosed, sputum-positive HIV-negative pulmonary TB patients were randomly allocated to receive gatifloxacin or moxifloxacin, along with isoniazid and rifampicin for 4 months with pyrazinamide for first 2 months (G or M) or isoniazid and rifampicin for 6 months with ethambutol and pyrazinamide for first 2 months (C). All regimens were administered thrice-weekly. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The Data and Safety Monitoring Board recommended termination of the trial due to high TB recurrence rates in the G and M regimens.<h4>Results</h4>Of 416 patients in intent-to-treat analysis, 6 (5%) of 124, 2 (2%) of 110 and 2 (2%) of 137 patients with drug-susceptible TB in the G, M and C arms respectively had unfavorable response at the end of treatment; during the next 24 months, 17 (15%) of 115, 11 (11%) of 104 and 8 (6%) of 132 patients respectively, had TB recurrence. Of 38 drug-resistant patients 1 of 8 and 3 of 26 in the G and C arms respectively had unfavourable response at the end of treatment; and TB recurrence occurred in 2 of 7 and 2 of 23 patients, respectively. The differences in TB recurrence rates between the G and C arms was statistically significant (p = 0.02). Gastro-intestinal symptoms occurred in 23%, 22% and 9% of patients in the G, M and C arms respectively, but most reactions were mild and manageable with symptomatic measures; 1% required regimen modification.<h4>Conclusions</h4>4-month thrice-weekly regimens of gatifloxacin or moxifloxacin with isoniazid, rifampicin and pyrazinamide, were inferior to standard 6-month treatment, in patients with newly diagnosed sputum positive pulmonary TB.<h4>Trial registration</h4>Clinical Trials Registry of India CTRI/2012/10/003060. |
| format | Article |
| id | doaj-art-4f627962931f4e438dcaffc0b3d5bbdd |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-4f627962931f4e438dcaffc0b3d5bbdd2025-08-20T03:53:42ZengPublic Library of Science (PLoS)PLoS ONE1932-62032013-01-0187e6703010.1371/journal.pone.0067030Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients.Mohideen S JawaharVaithilingam V BanurekhaChinnampedu N ParamasivanFathima RahmanRajeswari RamachandranPerumal VenkatesanRani BalasubramanianNagamiah SelvakumarChinnaiyan PonnurajaAllaudeen S IliayasNavaneethapandian P GangadeviBalambal RamanDhanaraj BaskaranSanthanakrishnan R KumarMarimuthu M KumarVictor MohanSudha GanapathyVanaja KumarGeetha ShanmugamNiruparani CharlesMurugesan R SakthivelKannivelu JagannathChockalingam ChandrasekarRamavaram T ParthasarathyParanji R Narayanan<h4>Background</h4>Shortening tuberculosis (TB) treatment duration is a research priority. This paper presents data from a prematurely terminated randomized clinical trial, of 4-month moxifloxacin or gatifloxacin regimens, in South India.<h4>Methods</h4>Newly diagnosed, sputum-positive HIV-negative pulmonary TB patients were randomly allocated to receive gatifloxacin or moxifloxacin, along with isoniazid and rifampicin for 4 months with pyrazinamide for first 2 months (G or M) or isoniazid and rifampicin for 6 months with ethambutol and pyrazinamide for first 2 months (C). All regimens were administered thrice-weekly. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The Data and Safety Monitoring Board recommended termination of the trial due to high TB recurrence rates in the G and M regimens.<h4>Results</h4>Of 416 patients in intent-to-treat analysis, 6 (5%) of 124, 2 (2%) of 110 and 2 (2%) of 137 patients with drug-susceptible TB in the G, M and C arms respectively had unfavorable response at the end of treatment; during the next 24 months, 17 (15%) of 115, 11 (11%) of 104 and 8 (6%) of 132 patients respectively, had TB recurrence. Of 38 drug-resistant patients 1 of 8 and 3 of 26 in the G and C arms respectively had unfavourable response at the end of treatment; and TB recurrence occurred in 2 of 7 and 2 of 23 patients, respectively. The differences in TB recurrence rates between the G and C arms was statistically significant (p = 0.02). Gastro-intestinal symptoms occurred in 23%, 22% and 9% of patients in the G, M and C arms respectively, but most reactions were mild and manageable with symptomatic measures; 1% required regimen modification.<h4>Conclusions</h4>4-month thrice-weekly regimens of gatifloxacin or moxifloxacin with isoniazid, rifampicin and pyrazinamide, were inferior to standard 6-month treatment, in patients with newly diagnosed sputum positive pulmonary TB.<h4>Trial registration</h4>Clinical Trials Registry of India CTRI/2012/10/003060.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0067030&type=printable |
| spellingShingle | Mohideen S Jawahar Vaithilingam V Banurekha Chinnampedu N Paramasivan Fathima Rahman Rajeswari Ramachandran Perumal Venkatesan Rani Balasubramanian Nagamiah Selvakumar Chinnaiyan Ponnuraja Allaudeen S Iliayas Navaneethapandian P Gangadevi Balambal Raman Dhanaraj Baskaran Santhanakrishnan R Kumar Marimuthu M Kumar Victor Mohan Sudha Ganapathy Vanaja Kumar Geetha Shanmugam Niruparani Charles Murugesan R Sakthivel Kannivelu Jagannath Chockalingam Chandrasekar Ramavaram T Parthasarathy Paranji R Narayanan Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients. PLoS ONE |
| title | Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients. |
| title_full | Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients. |
| title_fullStr | Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients. |
| title_full_unstemmed | Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients. |
| title_short | Randomized clinical trial of thrice-weekly 4-month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients. |
| title_sort | randomized clinical trial of thrice weekly 4 month moxifloxacin or gatifloxacin containing regimens in the treatment of new sputum positive pulmonary tuberculosis patients |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0067030&type=printable |
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