{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T19:51:36Z","timestamp":1792525896012,"version":"4.5.0"},"reference-count":17,"publisher":"Wiley","license":[{"start":{"date-parts":[[2011,1,1]],"date-time":"2011-01-01T00:00:00Z","timestamp":1293840000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Tropical Medicine"],"published-print":{"date-parts":[[2011]]},"abstract":"<jats:p><jats:italic>Background<\/jats:italic>. A phase 3 study demonstrated the safety and efficacy of paromomycin (paromomycin IM injection) for treatment of VL in an inpatient setting.<jats:italic>Methods<\/jats:italic>. 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.<jats:italic>Results<\/jats:italic>. 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 \u22651% were increases in alanine aminotransferase and aspartate aminotransferase.<jats:italic>Conclusions<\/jats:italic>. This study confirms the safety and efficacy of paromomycin to treat VL in an outpatient setting.<\/jats:p>","DOI":"10.1155\/2011\/645203","type":"journal-article","created":{"date-parts":[[2011,11,17]],"date-time":"2011-11-17T16:02:13Z","timestamp":1321545733000},"page":"1-7","source":"Crossref","is-referenced-by-count":47,"title":["Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India"],"prefix":"10.1155","volume":"2011","author":[{"given":"Prabhat K.","family":"Sinha","sequence":"first","affiliation":[{"name":"Rajendra Memorial Research Institute of Medical Sciences, Agam Kuan, Patna, Bihar 800 007, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T. 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