4‐month moxifloxacin containing regimens in the treatment of patients with sputum‐positive pulmonary tuberculosis in South India – a randomised clinical trial
Background Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3‐ and 4‐month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India. Methods New, sputum‐positive, adult, HIV‐negative, non...
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| Veröffentlicht in: | Tropical medicine & international health 2020-04, Vol.25 (4), p.483-495 |
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| creator | Velayutham, Banurekha Jawahar, Mohideen Shaheed Nair, Dina Navaneethapandian, Pooranagangadevi Ponnuraja, Chinnaiyan Chandrasekaran, Kandasamy Narayan Sivaramakrishnan, Gomathi Makesh Kumar, Marimuthu Paul Kumaran, Paramasivam Ramesh Kumar, Santhanakrishnan Baskaran, Dhanaraj Bella Devaleenal, Daniel Sirasanambati, Devarajulu Reddy Vasantha, Mahalingam Palaniyandi, Paramasivam Ramachandran, Geetha Uma Devi, Kadayam Ranganathan Elizabeth Hannah, Luke Sekar, Gomathi Radhakrishnan, Ammayappan Kalaiselvi, Dharuman Dhanalakshmi, Angamuthu Thiruvalluvan, Elangovan Raja Sakthivel, Murugesan Mahilmaran, Ayyamperumal Sridhar, Rathinam Jayabal, Lavanya Rathinam, Prabhakaran Angamuthu, Prabhakar Soorappa Ponnusamy, Kumaresan Venkatesan, Perumal Natrajan, Mohan Prasad Tripathy, Srikanth Swaminathan, Soumya |
| description | Background
Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3‐ and 4‐month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India.
Methods
New, sputum‐positive, adult, HIV‐negative, non‐diabetic PTB patients were randomised to 3‐ or 4‐month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H3R3Z3E3/4R3H3) [C]. The 4 test regimens were 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/2R3H3M3 [M4‐I] or 2R7H7Z7E7M7/2R3H3E3M3 [M4‐IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post‐treatment. The primary end point was TB recurrence post‐treatment.
Results
Of 1371 patients, randomised, modified intention‐to‐treat (ITT) analysis was done in 1329 and per‐protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. ‘Favourable’ response at end of treatment was 96–100% in the moxifloxacin regimens and 93% in the control regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI −3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4‐I and M4‐IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification.
Conclusion
The 4‐month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6‐month thrice‐weekly control regimen.
Contexte
La réduction de la durée du traitement de la tuberculose (TB) est une priorité de recherche. Nous avons testé l'efficacité et la sécurité de schémas thérapeutiques contenant de la moxifloxacine pendant 3 et 4 mois dans un essai clinique randomisé chez des patients atteints de TB pulmonaire (PTB) dans le sud de l’Inde.
Méthodes
De nouveaux patients PTB, adultes, non diabétiques, positifs pour les expectorations, VIH négatifs ont été randomisés pour des schémas thérapeutiques contenant de la moxifloxacine pendant 3 mois ou 4 mois [moxifloxacine (M), isoniazide (H), rifampicine (R), pyrazinamide (Z), l'éthambutol (E)] ou pour un régime témoin (2H3R3Z3E3/4R3H3) [C]. Les 4 régimes de l’essai étaient 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/ |
| doi_str_mv | 10.1111/tmi.13371 |
| format | Article |
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Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3‐ and 4‐month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India.
Methods
New, sputum‐positive, adult, HIV‐negative, non‐diabetic PTB patients were randomised to 3‐ or 4‐month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H3R3Z3E3/4R3H3) [C]. The 4 test regimens were 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/2R3H3M3 [M4‐I] or 2R7H7Z7E7M7/2R3H3E3M3 [M4‐IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post‐treatment. The primary end point was TB recurrence post‐treatment.
Results
Of 1371 patients, randomised, modified intention‐to‐treat (ITT) analysis was done in 1329 and per‐protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. ‘Favourable’ response at end of treatment was 96–100% in the moxifloxacin regimens and 93% in the control regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI −3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4‐I and M4‐IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification.
Conclusion
The 4‐month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6‐month thrice‐weekly control regimen.
Contexte
La réduction de la durée du traitement de la tuberculose (TB) est une priorité de recherche. Nous avons testé l'efficacité et la sécurité de schémas thérapeutiques contenant de la moxifloxacine pendant 3 et 4 mois dans un essai clinique randomisé chez des patients atteints de TB pulmonaire (PTB) dans le sud de l’Inde.
Méthodes
De nouveaux patients PTB, adultes, non diabétiques, positifs pour les expectorations, VIH négatifs ont été randomisés pour des schémas thérapeutiques contenant de la moxifloxacine pendant 3 mois ou 4 mois [moxifloxacine (M), isoniazide (H), rifampicine (R), pyrazinamide (Z), l'éthambutol (E)] ou pour un régime témoin (2H3R3Z3E3/4R3H3) [C]. Les 4 régimes de l’essai étaient 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/2R3H3M3 [M4‐I] ou 2R7H7Z7E7M7/2R3H3E3M3 [M4‐IE]. Le traitement a été directement observé. Les évaluations cliniques et bactériologiques ont été effectuées mensuellement au cours du traitement et durant 24 mois après le traitement. Le critère d'évaluation principal était la récidive de la TB après le traitement.
Résultats
Des 1.371 patients randomisés, une analyse en intention de traiter (ITT) modifiée a été effectuée sur 1.329 et une analyse par protocole (PP) sur 1.223 patients. Le régime M3 a été interrompu en raison de taux élevés de récidive de la TB. La réponse «favorable» à la fin du traitement était de 96 à 100% dans les bras moxifloxacine et 93% dans le bras témoin. Parmi ceux‐ci, la récidive de la TB est survenue chez 4,1% dans le schéma M4 et chez 4,5% dans le schéma témoin et a démontré une équivalence dans une marge de 5% (IC95%: −3,68, 4,55). Des résultats similaires ont été observés dans l'analyse ITT modifiée. Les taux de récidive de la TB dans les schémas M4‐I et M4‐IE n'ont pas montré d'équivalence avec le schéma témoin. 16 (1,4%) des 1.087 patients dans les régimes à moxifloxacine ont nécessité une modification du traitement.
Conclusion
Le régime quotidien de moxifloxacine pendant 4 mois [M4] s'est avéré équivalent et aussi sûr que le régime témoin de trois fois par semaine pendant 6 mois.</description><identifier>ISSN: 1360-2276</identifier><identifier>EISSN: 1365-3156</identifier><identifier>DOI: 10.1111/tmi.13371</identifier><identifier>PMID: 31944502</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adult ; Antibiotics ; Antitubercular Agents - administration & dosage ; Antitubercular Agents - therapeutic use ; chemotherapy of tuberculosis ; chimiothérapie de courte durée ; chimiothérapie de la tuberculose ; Clinical trials ; Diabetes mellitus ; Drug Administration Schedule ; Equivalence ; Ethambutol ; Female ; fluoroquinolones ; HIV ; Human immunodeficiency virus ; Humans ; India ; Isoniazid ; Male ; Moxifloxacin ; Moxifloxacin - administration & dosage ; Moxifloxacin - therapeutic use ; moxifloxacine ; Patients ; Pyrazinamide ; Randomization ; Rifampin ; short course chemotherapy ; Sputum ; Sputum - microbiology ; Treatment Outcome ; tuberculose ; Tuberculosis ; Tuberculosis, Pulmonary - drug therapy ; Tuberculosis, Pulmonary - microbiology</subject><ispartof>Tropical medicine & international health, 2020-04, Vol.25 (4), p.483-495</ispartof><rights>2020 John Wiley & Sons Ltd</rights><rights>2020 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3881-99f12d523907e050344ea44598e04cea1e76aa60c47b395a35947a1d5feccd463</citedby><cites>FETCH-LOGICAL-c3881-99f12d523907e050344ea44598e04cea1e76aa60c47b395a35947a1d5feccd463</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Ftmi.13371$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Ftmi.13371$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31944502$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Velayutham, Banurekha</creatorcontrib><creatorcontrib>Jawahar, Mohideen Shaheed</creatorcontrib><creatorcontrib>Nair, Dina</creatorcontrib><creatorcontrib>Navaneethapandian, Pooranagangadevi</creatorcontrib><creatorcontrib>Ponnuraja, Chinnaiyan</creatorcontrib><creatorcontrib>Chandrasekaran, Kandasamy</creatorcontrib><creatorcontrib>Narayan Sivaramakrishnan, Gomathi</creatorcontrib><creatorcontrib>Makesh Kumar, Marimuthu</creatorcontrib><creatorcontrib>Paul Kumaran, Paramasivam</creatorcontrib><creatorcontrib>Ramesh Kumar, Santhanakrishnan</creatorcontrib><creatorcontrib>Baskaran, Dhanaraj</creatorcontrib><creatorcontrib>Bella Devaleenal, Daniel</creatorcontrib><creatorcontrib>Sirasanambati, Devarajulu Reddy</creatorcontrib><creatorcontrib>Vasantha, Mahalingam</creatorcontrib><creatorcontrib>Palaniyandi, Paramasivam</creatorcontrib><creatorcontrib>Ramachandran, Geetha</creatorcontrib><creatorcontrib>Uma Devi, Kadayam Ranganathan</creatorcontrib><creatorcontrib>Elizabeth Hannah, Luke</creatorcontrib><creatorcontrib>Sekar, Gomathi</creatorcontrib><creatorcontrib>Radhakrishnan, Ammayappan</creatorcontrib><creatorcontrib>Kalaiselvi, Dharuman</creatorcontrib><creatorcontrib>Dhanalakshmi, Angamuthu</creatorcontrib><creatorcontrib>Thiruvalluvan, Elangovan</creatorcontrib><creatorcontrib>Raja Sakthivel, Murugesan</creatorcontrib><creatorcontrib>Mahilmaran, Ayyamperumal</creatorcontrib><creatorcontrib>Sridhar, Rathinam</creatorcontrib><creatorcontrib>Jayabal, Lavanya</creatorcontrib><creatorcontrib>Rathinam, Prabhakaran</creatorcontrib><creatorcontrib>Angamuthu, Prabhakar</creatorcontrib><creatorcontrib>Soorappa Ponnusamy, Kumaresan</creatorcontrib><creatorcontrib>Venkatesan, Perumal</creatorcontrib><creatorcontrib>Natrajan, Mohan</creatorcontrib><creatorcontrib>Prasad Tripathy, Srikanth</creatorcontrib><creatorcontrib>Swaminathan, Soumya</creatorcontrib><title>4‐month moxifloxacin containing regimens in the treatment of patients with sputum‐positive pulmonary tuberculosis in South India – a randomised clinical trial</title><title>Tropical medicine & international health</title><addtitle>Trop Med Int Health</addtitle><description>Background
Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3‐ and 4‐month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India.
Methods
New, sputum‐positive, adult, HIV‐negative, non‐diabetic PTB patients were randomised to 3‐ or 4‐month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H3R3Z3E3/4R3H3) [C]. The 4 test regimens were 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/2R3H3M3 [M4‐I] or 2R7H7Z7E7M7/2R3H3E3M3 [M4‐IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post‐treatment. The primary end point was TB recurrence post‐treatment.
Results
Of 1371 patients, randomised, modified intention‐to‐treat (ITT) analysis was done in 1329 and per‐protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. ‘Favourable’ response at end of treatment was 96–100% in the moxifloxacin regimens and 93% in the control regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI −3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4‐I and M4‐IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification.
Conclusion
The 4‐month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6‐month thrice‐weekly control regimen.
Contexte
La réduction de la durée du traitement de la tuberculose (TB) est une priorité de recherche. Nous avons testé l'efficacité et la sécurité de schémas thérapeutiques contenant de la moxifloxacine pendant 3 et 4 mois dans un essai clinique randomisé chez des patients atteints de TB pulmonaire (PTB) dans le sud de l’Inde.
Méthodes
De nouveaux patients PTB, adultes, non diabétiques, positifs pour les expectorations, VIH négatifs ont été randomisés pour des schémas thérapeutiques contenant de la moxifloxacine pendant 3 mois ou 4 mois [moxifloxacine (M), isoniazide (H), rifampicine (R), pyrazinamide (Z), l'éthambutol (E)] ou pour un régime témoin (2H3R3Z3E3/4R3H3) [C]. Les 4 régimes de l’essai étaient 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/2R3H3M3 [M4‐I] ou 2R7H7Z7E7M7/2R3H3E3M3 [M4‐IE]. Le traitement a été directement observé. Les évaluations cliniques et bactériologiques ont été effectuées mensuellement au cours du traitement et durant 24 mois après le traitement. Le critère d'évaluation principal était la récidive de la TB après le traitement.
Résultats
Des 1.371 patients randomisés, une analyse en intention de traiter (ITT) modifiée a été effectuée sur 1.329 et une analyse par protocole (PP) sur 1.223 patients. Le régime M3 a été interrompu en raison de taux élevés de récidive de la TB. La réponse «favorable» à la fin du traitement était de 96 à 100% dans les bras moxifloxacine et 93% dans le bras témoin. Parmi ceux‐ci, la récidive de la TB est survenue chez 4,1% dans le schéma M4 et chez 4,5% dans le schéma témoin et a démontré une équivalence dans une marge de 5% (IC95%: −3,68, 4,55). Des résultats similaires ont été observés dans l'analyse ITT modifiée. Les taux de récidive de la TB dans les schémas M4‐I et M4‐IE n'ont pas montré d'équivalence avec le schéma témoin. 16 (1,4%) des 1.087 patients dans les régimes à moxifloxacine ont nécessité une modification du traitement.
Conclusion
Le régime quotidien de moxifloxacine pendant 4 mois [M4] s'est avéré équivalent et aussi sûr que le régime témoin de trois fois par semaine pendant 6 mois.</description><subject>Adult</subject><subject>Antibiotics</subject><subject>Antitubercular Agents - administration & dosage</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>chemotherapy of tuberculosis</subject><subject>chimiothérapie de courte durée</subject><subject>chimiothérapie de la tuberculose</subject><subject>Clinical trials</subject><subject>Diabetes mellitus</subject><subject>Drug Administration Schedule</subject><subject>Equivalence</subject><subject>Ethambutol</subject><subject>Female</subject><subject>fluoroquinolones</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>India</subject><subject>Isoniazid</subject><subject>Male</subject><subject>Moxifloxacin</subject><subject>Moxifloxacin - administration & dosage</subject><subject>Moxifloxacin - therapeutic use</subject><subject>moxifloxacine</subject><subject>Patients</subject><subject>Pyrazinamide</subject><subject>Randomization</subject><subject>Rifampin</subject><subject>short course chemotherapy</subject><subject>Sputum</subject><subject>Sputum - microbiology</subject><subject>Treatment Outcome</subject><subject>tuberculose</subject><subject>Tuberculosis</subject><subject>Tuberculosis, Pulmonary - drug therapy</subject><subject>Tuberculosis, Pulmonary - microbiology</subject><issn>1360-2276</issn><issn>1365-3156</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUluFTEQQFsIRAZYcAFkiQ0sOvHUg5coYvhSIhYJ65a_uzpx5LYbDyTZ5QhIXCEny0mo_B9YIMUbl8rPr8quqnrD6AHDdZhne8CE6NizapeJtqkFa9rnm5jWnHftTrWX0iWlVMqmfVntCKYwony3upP3t7_m4PMFmcO1nVy41sZ6YjClrbf-nEQ4tzP4RDCdL4DkCDpjIpMwkUVni2EiVxYVaSm5zGhcQrLZ_gSyFId2HW9ILmuIpjg82ahOQ8EbKz9aTe5vfxNNovZjmG2CkRiHtY12WMxq96p6MWmX4PXjvl99__zp7Ohrffzty-ro43FtRN-zWqmJ8bHhQtEOaEOFlKDxnaoHKg1oBl2rdUuN7NZCNVo0Snaajc0ExoyyFfvV-613ieFHgZQH7MaAc9pDKGngQqiu7xWniL77D70MJXrsDinFGZeSCqQ-bCkTQ0oRpmGJdsbfGBgdHkY34OiGzeiQfftoLOsZxn_k31khcLgFrqyDm6dNw9nJaqv8A_OnqKA</recordid><startdate>202004</startdate><enddate>202004</enddate><creator>Velayutham, Banurekha</creator><creator>Jawahar, Mohideen Shaheed</creator><creator>Nair, Dina</creator><creator>Navaneethapandian, Pooranagangadevi</creator><creator>Ponnuraja, Chinnaiyan</creator><creator>Chandrasekaran, Kandasamy</creator><creator>Narayan Sivaramakrishnan, Gomathi</creator><creator>Makesh Kumar, Marimuthu</creator><creator>Paul Kumaran, Paramasivam</creator><creator>Ramesh Kumar, Santhanakrishnan</creator><creator>Baskaran, Dhanaraj</creator><creator>Bella Devaleenal, Daniel</creator><creator>Sirasanambati, Devarajulu Reddy</creator><creator>Vasantha, Mahalingam</creator><creator>Palaniyandi, Paramasivam</creator><creator>Ramachandran, Geetha</creator><creator>Uma Devi, Kadayam Ranganathan</creator><creator>Elizabeth Hannah, Luke</creator><creator>Sekar, Gomathi</creator><creator>Radhakrishnan, Ammayappan</creator><creator>Kalaiselvi, Dharuman</creator><creator>Dhanalakshmi, Angamuthu</creator><creator>Thiruvalluvan, Elangovan</creator><creator>Raja Sakthivel, Murugesan</creator><creator>Mahilmaran, Ayyamperumal</creator><creator>Sridhar, Rathinam</creator><creator>Jayabal, Lavanya</creator><creator>Rathinam, Prabhakaran</creator><creator>Angamuthu, Prabhakar</creator><creator>Soorappa Ponnusamy, Kumaresan</creator><creator>Venkatesan, Perumal</creator><creator>Natrajan, Mohan</creator><creator>Prasad Tripathy, Srikanth</creator><creator>Swaminathan, Soumya</creator><general>Blackwell Publishing Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope></search><sort><creationdate>202004</creationdate><title>4‐month moxifloxacin containing regimens in the treatment of patients with sputum‐positive pulmonary tuberculosis in South India – a randomised clinical trial</title><author>Velayutham, Banurekha ; Jawahar, Mohideen Shaheed ; Nair, Dina ; Navaneethapandian, Pooranagangadevi ; Ponnuraja, Chinnaiyan ; Chandrasekaran, Kandasamy ; Narayan Sivaramakrishnan, Gomathi ; Makesh Kumar, Marimuthu ; Paul Kumaran, Paramasivam ; Ramesh Kumar, Santhanakrishnan ; Baskaran, Dhanaraj ; Bella Devaleenal, Daniel ; Sirasanambati, Devarajulu Reddy ; Vasantha, Mahalingam ; Palaniyandi, Paramasivam ; Ramachandran, Geetha ; Uma Devi, Kadayam Ranganathan ; Elizabeth Hannah, Luke ; Sekar, Gomathi ; Radhakrishnan, Ammayappan ; Kalaiselvi, Dharuman ; Dhanalakshmi, Angamuthu ; Thiruvalluvan, Elangovan ; Raja Sakthivel, Murugesan ; Mahilmaran, Ayyamperumal ; Sridhar, Rathinam ; Jayabal, Lavanya ; Rathinam, Prabhakaran ; Angamuthu, Prabhakar ; Soorappa Ponnusamy, Kumaresan ; Venkatesan, Perumal ; Natrajan, Mohan ; Prasad Tripathy, Srikanth ; Swaminathan, Soumya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3881-99f12d523907e050344ea44598e04cea1e76aa60c47b395a35947a1d5feccd463</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Antibiotics</topic><topic>Antitubercular Agents - administration & dosage</topic><topic>Antitubercular Agents - therapeutic use</topic><topic>chemotherapy of tuberculosis</topic><topic>chimiothérapie de courte durée</topic><topic>chimiothérapie de la tuberculose</topic><topic>Clinical trials</topic><topic>Diabetes mellitus</topic><topic>Drug Administration Schedule</topic><topic>Equivalence</topic><topic>Ethambutol</topic><topic>Female</topic><topic>fluoroquinolones</topic><topic>HIV</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>India</topic><topic>Isoniazid</topic><topic>Male</topic><topic>Moxifloxacin</topic><topic>Moxifloxacin - administration & dosage</topic><topic>Moxifloxacin - therapeutic use</topic><topic>moxifloxacine</topic><topic>Patients</topic><topic>Pyrazinamide</topic><topic>Randomization</topic><topic>Rifampin</topic><topic>short course chemotherapy</topic><topic>Sputum</topic><topic>Sputum - microbiology</topic><topic>Treatment Outcome</topic><topic>tuberculose</topic><topic>Tuberculosis</topic><topic>Tuberculosis, Pulmonary - drug therapy</topic><topic>Tuberculosis, Pulmonary - microbiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Velayutham, Banurekha</creatorcontrib><creatorcontrib>Jawahar, Mohideen Shaheed</creatorcontrib><creatorcontrib>Nair, Dina</creatorcontrib><creatorcontrib>Navaneethapandian, Pooranagangadevi</creatorcontrib><creatorcontrib>Ponnuraja, Chinnaiyan</creatorcontrib><creatorcontrib>Chandrasekaran, Kandasamy</creatorcontrib><creatorcontrib>Narayan Sivaramakrishnan, Gomathi</creatorcontrib><creatorcontrib>Makesh Kumar, Marimuthu</creatorcontrib><creatorcontrib>Paul Kumaran, Paramasivam</creatorcontrib><creatorcontrib>Ramesh Kumar, Santhanakrishnan</creatorcontrib><creatorcontrib>Baskaran, Dhanaraj</creatorcontrib><creatorcontrib>Bella Devaleenal, Daniel</creatorcontrib><creatorcontrib>Sirasanambati, Devarajulu Reddy</creatorcontrib><creatorcontrib>Vasantha, Mahalingam</creatorcontrib><creatorcontrib>Palaniyandi, Paramasivam</creatorcontrib><creatorcontrib>Ramachandran, Geetha</creatorcontrib><creatorcontrib>Uma Devi, Kadayam Ranganathan</creatorcontrib><creatorcontrib>Elizabeth Hannah, Luke</creatorcontrib><creatorcontrib>Sekar, Gomathi</creatorcontrib><creatorcontrib>Radhakrishnan, Ammayappan</creatorcontrib><creatorcontrib>Kalaiselvi, Dharuman</creatorcontrib><creatorcontrib>Dhanalakshmi, Angamuthu</creatorcontrib><creatorcontrib>Thiruvalluvan, Elangovan</creatorcontrib><creatorcontrib>Raja Sakthivel, Murugesan</creatorcontrib><creatorcontrib>Mahilmaran, Ayyamperumal</creatorcontrib><creatorcontrib>Sridhar, Rathinam</creatorcontrib><creatorcontrib>Jayabal, Lavanya</creatorcontrib><creatorcontrib>Rathinam, Prabhakaran</creatorcontrib><creatorcontrib>Angamuthu, Prabhakar</creatorcontrib><creatorcontrib>Soorappa Ponnusamy, Kumaresan</creatorcontrib><creatorcontrib>Venkatesan, Perumal</creatorcontrib><creatorcontrib>Natrajan, Mohan</creatorcontrib><creatorcontrib>Prasad Tripathy, Srikanth</creatorcontrib><creatorcontrib>Swaminathan, Soumya</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Tropical medicine & international health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Velayutham, Banurekha</au><au>Jawahar, Mohideen Shaheed</au><au>Nair, Dina</au><au>Navaneethapandian, Pooranagangadevi</au><au>Ponnuraja, Chinnaiyan</au><au>Chandrasekaran, Kandasamy</au><au>Narayan Sivaramakrishnan, Gomathi</au><au>Makesh Kumar, Marimuthu</au><au>Paul Kumaran, Paramasivam</au><au>Ramesh Kumar, Santhanakrishnan</au><au>Baskaran, Dhanaraj</au><au>Bella Devaleenal, Daniel</au><au>Sirasanambati, Devarajulu Reddy</au><au>Vasantha, Mahalingam</au><au>Palaniyandi, Paramasivam</au><au>Ramachandran, Geetha</au><au>Uma Devi, Kadayam Ranganathan</au><au>Elizabeth Hannah, Luke</au><au>Sekar, Gomathi</au><au>Radhakrishnan, Ammayappan</au><au>Kalaiselvi, Dharuman</au><au>Dhanalakshmi, Angamuthu</au><au>Thiruvalluvan, Elangovan</au><au>Raja Sakthivel, Murugesan</au><au>Mahilmaran, Ayyamperumal</au><au>Sridhar, Rathinam</au><au>Jayabal, Lavanya</au><au>Rathinam, Prabhakaran</au><au>Angamuthu, Prabhakar</au><au>Soorappa Ponnusamy, Kumaresan</au><au>Venkatesan, Perumal</au><au>Natrajan, Mohan</au><au>Prasad Tripathy, Srikanth</au><au>Swaminathan, Soumya</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>4‐month moxifloxacin containing regimens in the treatment of patients with sputum‐positive pulmonary tuberculosis in South India – a randomised clinical trial</atitle><jtitle>Tropical medicine & international health</jtitle><addtitle>Trop Med Int Health</addtitle><date>2020-04</date><risdate>2020</risdate><volume>25</volume><issue>4</issue><spage>483</spage><epage>495</epage><pages>483-495</pages><issn>1360-2276</issn><eissn>1365-3156</eissn><abstract>Background
Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3‐ and 4‐month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India.
Methods
New, sputum‐positive, adult, HIV‐negative, non‐diabetic PTB patients were randomised to 3‐ or 4‐month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H3R3Z3E3/4R3H3) [C]. The 4 test regimens were 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/2R3H3M3 [M4‐I] or 2R7H7Z7E7M7/2R3H3E3M3 [M4‐IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post‐treatment. The primary end point was TB recurrence post‐treatment.
Results
Of 1371 patients, randomised, modified intention‐to‐treat (ITT) analysis was done in 1329 and per‐protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. ‘Favourable’ response at end of treatment was 96–100% in the moxifloxacin regimens and 93% in the control regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI −3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4‐I and M4‐IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification.
Conclusion
The 4‐month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6‐month thrice‐weekly control regimen.
Contexte
La réduction de la durée du traitement de la tuberculose (TB) est une priorité de recherche. Nous avons testé l'efficacité et la sécurité de schémas thérapeutiques contenant de la moxifloxacine pendant 3 et 4 mois dans un essai clinique randomisé chez des patients atteints de TB pulmonaire (PTB) dans le sud de l’Inde.
Méthodes
De nouveaux patients PTB, adultes, non diabétiques, positifs pour les expectorations, VIH négatifs ont été randomisés pour des schémas thérapeutiques contenant de la moxifloxacine pendant 3 mois ou 4 mois [moxifloxacine (M), isoniazide (H), rifampicine (R), pyrazinamide (Z), l'éthambutol (E)] ou pour un régime témoin (2H3R3Z3E3/4R3H3) [C]. Les 4 régimes de l’essai étaient 3R7H7Z7E7M7 [M3], 2R7H7Z7E7M7/2R7H7M7 [M4], 2R7H7Z7E7M7/2R3H3M3 [M4‐I] ou 2R7H7Z7E7M7/2R3H3E3M3 [M4‐IE]. Le traitement a été directement observé. Les évaluations cliniques et bactériologiques ont été effectuées mensuellement au cours du traitement et durant 24 mois après le traitement. Le critère d'évaluation principal était la récidive de la TB après le traitement.
Résultats
Des 1.371 patients randomisés, une analyse en intention de traiter (ITT) modifiée a été effectuée sur 1.329 et une analyse par protocole (PP) sur 1.223 patients. Le régime M3 a été interrompu en raison de taux élevés de récidive de la TB. La réponse «favorable» à la fin du traitement était de 96 à 100% dans les bras moxifloxacine et 93% dans le bras témoin. Parmi ceux‐ci, la récidive de la TB est survenue chez 4,1% dans le schéma M4 et chez 4,5% dans le schéma témoin et a démontré une équivalence dans une marge de 5% (IC95%: −3,68, 4,55). Des résultats similaires ont été observés dans l'analyse ITT modifiée. Les taux de récidive de la TB dans les schémas M4‐I et M4‐IE n'ont pas montré d'équivalence avec le schéma témoin. 16 (1,4%) des 1.087 patients dans les régimes à moxifloxacine ont nécessité une modification du traitement.
Conclusion
Le régime quotidien de moxifloxacine pendant 4 mois [M4] s'est avéré équivalent et aussi sûr que le régime témoin de trois fois par semaine pendant 6 mois.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>31944502</pmid><doi>10.1111/tmi.13371</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1360-2276 |
| ispartof | Tropical medicine & international health, 2020-04, Vol.25 (4), p.483-495 |
| issn | 1360-2276 1365-3156 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Wiley Online Library Free Content; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Adult Antibiotics Antitubercular Agents - administration & dosage Antitubercular Agents - therapeutic use chemotherapy of tuberculosis chimiothérapie de courte durée chimiothérapie de la tuberculose Clinical trials Diabetes mellitus Drug Administration Schedule Equivalence Ethambutol Female fluoroquinolones HIV Human immunodeficiency virus Humans India Isoniazid Male Moxifloxacin Moxifloxacin - administration & dosage Moxifloxacin - therapeutic use moxifloxacine Patients Pyrazinamide Randomization Rifampin short course chemotherapy Sputum Sputum - microbiology Treatment Outcome tuberculose Tuberculosis Tuberculosis, Pulmonary - drug therapy Tuberculosis, Pulmonary - microbiology |
| title | 4‐month moxifloxacin containing regimens in the treatment of patients with sputum‐positive pulmonary tuberculosis in South India – a randomised clinical trial |
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