Trial reportThe American journal of tropical medicine and hygiene2026
Value of the Run-In Period to Evaluate the Safety of Conventional Trypanocidal Treatment: A Subanalysis of a Colombian Randomized Clinical Trial.
Trial report in The American journal of tropical medicine and hygiene, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
When testing poorly tolerated or long-term treatments, including a run-in phase enhances clinical trial efficiency and internal validity by selecting more adherent participants. This report describes the adherence and tolerance of Colombian participants in EQUITY (a randomized, concealed, parallel-group, placebo-controlled trial testing nifurtimox and benznidazole among Trypanosoma cruzi-seropositive adults without cardiomyopathy). Our design included a 10-day, single-blind, placebo run-in phase. On completion, willing participants reporting good adherence (≥80%) and tolerance were randomized to any five 120-day, blinded treatments: four with either active medication, each given as 120-day half dose or 60-day full dose (followed/preceded by a randomly allocated 60-day placebo treatment), or a 120-day placebo. Side effects were compared after the run-in (day 0) between excluded and enrolled participants, and between those randomized to active medications or placebo 20 days after starting each treatment period (days 20/80). Those excluded (44/351, 12.5%) more often reported gastrointestinal (15.9/4.6%), nonspecific (13.7/4.2%), and musculoskeletal symptoms (9.1/1.6%) than those randomized. Participants given nifurtimox (n = 84) or benznidazole (n = 86) versus placebo (n = 126) on day 20 reported more nonspecific (15.5/10.5/4.8%, respectively) or cutaneous side effects (6.0/12.8/3.2%). When starting active treatments (transition OFF-ON, n = 171 and n = 61 in first and second 60-day treatment periods), more participants reported emerging-worsening than receding-ending side effects (49/13 and 15/5, respectively). Despite inducing a nocebo effect, the run-in phase highlighted more closely related side effects, strengthening causal inference and informing adherence and tolerance to conventional trypanocides.
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