Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India
Background. A phase 3 study demonstrated the safety and efficacy of paromomycin (paromomycin IM injection) for treatment of VL in an inpatient setting. Methods. This phase 4 study was conducted to assess the safety and efficacy of paromomycin in children and adults in an outpatient setting in Bihar,...
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ftdoajarticles:oai:doaj.org/article:b5a7aebbbb40471d92ef2b0737cc0312 2023-05-15T15:04:44+02:00 Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India Prabhat K. Sinha T. K. Jha Chandreshwar P. Thakur Devendra Nath Supriyo Mukherjee Amrendra Kumar Aditya Shyam Sundar 2011-01-01T00:00:00Z https://doi.org/10.1155/2011/645203 https://doaj.org/article/b5a7aebbbb40471d92ef2b0737cc0312 EN eng Hindawi Limited http://dx.doi.org/10.1155/2011/645203 https://doaj.org/toc/1687-9686 https://doaj.org/toc/1687-9694 1687-9686 1687-9694 doi:10.1155/2011/645203 https://doaj.org/article/b5a7aebbbb40471d92ef2b0737cc0312 Journal of Tropical Medicine, Vol 2011 (2011) Arctic medicine. Tropical medicine RC955-962 article 2011 ftdoajarticles https://doi.org/10.1155/2011/645203 2022-12-31T14:43:39Z Background. A phase 3 study demonstrated the safety and efficacy of paromomycin (paromomycin IM injection) for treatment of VL in an inpatient setting. Methods. This phase 4 study was conducted to assess the safety and efficacy of paromomycin in children and adults in an outpatient setting in Bihar, India. Results. This study enrolled 506 adult and pediatric patients. Of the 494 patients in the intent-to-treat (ITT) population, 98% received a full course of treatment. The overall study completion rate was 94% (462/494) for the ITT population and 96% (461/479) for the efficacy-evaluable (EE) population. Initial clinical cure was 99.6%, and final clinical cure 6 months after treatment was 94.2%. Grade 3 or 4 adverse events occurred in 5% of patients; events with a frequency of ≥1% were increases in alanine aminotransferase and aspartate aminotransferase. Conclusions. This study confirms the safety and efficacy of paromomycin to treat VL in an outpatient setting. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Journal of Tropical Medicine 2011 1 7 |
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Directory of Open Access Journals: DOAJ Articles |
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English |
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Arctic medicine. Tropical medicine RC955-962 |
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Arctic medicine. Tropical medicine RC955-962 Prabhat K. Sinha T. K. Jha Chandreshwar P. Thakur Devendra Nath Supriyo Mukherjee Amrendra Kumar Aditya Shyam Sundar Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 |
description |
Background. A phase 3 study demonstrated the safety and efficacy of paromomycin (paromomycin IM injection) for treatment of VL in an inpatient setting. Methods. This phase 4 study was conducted to assess the safety and efficacy of paromomycin in children and adults in an outpatient setting in Bihar, India. Results. This study enrolled 506 adult and pediatric patients. Of the 494 patients in the intent-to-treat (ITT) population, 98% received a full course of treatment. The overall study completion rate was 94% (462/494) for the ITT population and 96% (461/479) for the efficacy-evaluable (EE) population. Initial clinical cure was 99.6%, and final clinical cure 6 months after treatment was 94.2%. Grade 3 or 4 adverse events occurred in 5% of patients; events with a frequency of ≥1% were increases in alanine aminotransferase and aspartate aminotransferase. Conclusions. This study confirms the safety and efficacy of paromomycin to treat VL in an outpatient setting. |
format |
Article in Journal/Newspaper |
author |
Prabhat K. Sinha T. K. Jha Chandreshwar P. Thakur Devendra Nath Supriyo Mukherjee Amrendra Kumar Aditya Shyam Sundar |
author_facet |
Prabhat K. Sinha T. K. Jha Chandreshwar P. Thakur Devendra Nath Supriyo Mukherjee Amrendra Kumar Aditya Shyam Sundar |
author_sort |
Prabhat K. Sinha |
title |
Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India |
title_short |
Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India |
title_full |
Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India |
title_fullStr |
Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India |
title_full_unstemmed |
Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India |
title_sort |
phase 4 pharmacovigilance trial of paromomycin injection for the treatment of visceral leishmaniasis in india |
publisher |
Hindawi Limited |
publishDate |
2011 |
url |
https://doi.org/10.1155/2011/645203 https://doaj.org/article/b5a7aebbbb40471d92ef2b0737cc0312 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Journal of Tropical Medicine, Vol 2011 (2011) |
op_relation |
http://dx.doi.org/10.1155/2011/645203 https://doaj.org/toc/1687-9686 https://doaj.org/toc/1687-9694 1687-9686 1687-9694 doi:10.1155/2011/645203 https://doaj.org/article/b5a7aebbbb40471d92ef2b0737cc0312 |
op_doi |
https://doi.org/10.1155/2011/645203 |
container_title |
Journal of Tropical Medicine |
container_volume |
2011 |
container_start_page |
1 |
op_container_end_page |
7 |
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1766336465420156928 |