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. 2011:2011:645203.
doi: 10.1155/2011/645203. Epub 2011 Nov 17.

Phase 4 pharmacovigilance trial of paromomycin injection for the treatment of visceral leishmaniasis in India

Prabhat K Sinha  1 , T K Jha, Chandreshwar P Thakur, Devendra Nath, Supriyo Mukherjee, Amrendra Kumar Aditya, Shyam Sundar
Affiliations

Phase 4 pharmacovigilance trial of paromomycin injection for the treatment of visceral leishmaniasis in India

Prabhat K Sinha et al. J Trop Med. 2011.

Abstract

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.

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Figures

Figure 1
Figure 1
Disposition of patients in the intent-to-treat population.
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