Jayapura City

Researchers are evaluating the safety, tolerability, and effectiveness of adding metformin to standard multidrug therapy MDT for patients newly diagnosed with multibacillary leprosy. This double-blind, placebo-controlled Phase 2 trial aims to see if metformin can reduce leprosy reactions, nerve damage, and corticosteroid use while assessing immunological responses. The study is supported by the Leprosy Research Initiative and conducted in Indonesia with participants aged 18 to 65. Participants will be randomly assigned to receive either metformin or a placebo once daily. Metformin dosing starts at 500mg for two weeks, then increases to 1000mg for 22 weeks, alongside 48 weeks of standard MDT. The placebo group receives matching tablets to maintain blinding. The trial plans to enroll 166 patients to compare clinical outcomes between the two groups. During the 48-week study, participants will be regularly monitored for leprosy reactions, adverse events, nerve function, corticosteroid use, and quality of life through clinical assessments and questionnaires. The primary outcomes include the proportion of patients experiencing leprosy reactions and adverse events within specified timeframes. Secondary outcomes focus on reaction severity, timing, frequency, and impact on daily living. Safety and tolerability will also be closely observed throughout the study period.

This research aims to find the best single dose of tafenoquine to treat Plasmodium vivax malaria in Southeast Asia. Tafenoquine is a recently approved alternative to the 14-day primaquine treatment for the dormant liver stage of this malaria type. Previous studies showed the standard 300 mg tafenoquine dose was less effective in Southeast Asia compared to higher doses of primaquine, highlighting the need to optimize tafenoquine dosing. Participants will be randomly assigned to receive either the current recommended tafenoquine dose or a 50% higher dose, both given as a single dose based on weight bands. An additional arm with high-dose primaquine is included only in Indonesia to compare with national treatment standards. All tafenoquine doses will be given with a schizonticidal agent, such as chloroquine or artemether-lumefantrine, with drug administration closely observed by study staff. Participants will be followed daily until malaria parasites clear, then at scheduled visits up to four months to monitor for recurrence and side effects. Study activities include blood tests, physical exams, vital signs, pregnancy and enzyme activity testing, and adverse event tracking. Data will be securely recorded and analyzed to compare treatment effectiveness and safety. Participants may withdraw at any time, and those with ongoing issues at study end will receive appropriate follow-up care.