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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| Format: | Article |
| Language: | English |
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Wiley
2011-01-01
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| Series: | Journal of Tropical Medicine |
| Online Access: | http://dx.doi.org/10.1155/2011/645203 |
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| 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 |
| collection | DOAJ |
| 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 |
| id | doaj-art-b5a7aebbbb40471d92ef2b0737cc0312 |
| institution | Kabale University |
| issn | 1687-9686 1687-9694 |
| language | English |
| publishDate | 2011-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Tropical Medicine |
| spelling | doaj-art-b5a7aebbbb40471d92ef2b0737cc03122025-02-03T00:59:49ZengWileyJournal of Tropical Medicine1687-96861687-96942011-01-01201110.1155/2011/645203645203Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in IndiaPrabhat K. Sinha0T. K. Jha1Chandreshwar P. Thakur2Devendra Nath3Supriyo Mukherjee4Amrendra Kumar Aditya5Shyam Sundar6Rajendra Memorial Research Institute of Medical Sciences, Agam Kuan, Patna, Bihar 800 007, IndiaKala-Azar Research Centre, Brahmpura, Muzaffarpur, Bihar, IndiaBalaji Utthan Sansthan, Patna, Bihar, IndiaHazari Medical and Maternity Care, Motihari, Bihar, IndiaResearch Centre for Diabetes, Hypertension, and Obesity, Samastipur, Bihar, IndiaDr. A. K. Aditya Clinic, Samastipur, Bihar, IndiaInstitute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, IndiaBackground. 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.http://dx.doi.org/10.1155/2011/645203 |
| spellingShingle | 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 Journal of Tropical Medicine |
| title | 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_short | 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 |
| url | http://dx.doi.org/10.1155/2011/645203 |
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