A phase I/II randomized controlled clinical trial to assess the feasibility, safety, and preliminary effectiveness of paracetamol in resolving acute kidney injury in children with severe malaria
Abstract
BACKGROUND: Acute kidney injury (AKI) is prevalent among children with severe malaria, contributing to considerable morbidity and mortality. Oxidative stress has been implicated in the pathophysiology of malaria-induced AKI, and paracetamol, with its antioxidant properties, has been proposed as a solution. This phase I/II randomized trial evaluated paracetamol as a potential renoprotective adjunct in children with severe malaria and acute kidney injury.
METHODS: We conducted a phase I/II open label parallel randomized controlled trial of 40 hospitalized children aged > 6 months to < 12 years with malaria-induced AKI in eastern Uganda. Participants were randomized by a sealed envelope 1:1 to receive either oral paracetamol 20 mg/kg 6 hourly for 48 h or tepid sponging every 30 min until fever subsided. Only the assessors of the primary outcome were masked to the intervention. The primary outcome was renal recovery at 48 h assessed using restricted mean survival time (RMST) in intention to treat population of children according to their randomization groups.
RESULTS: Between 19 September 2021 and 25 August 2023, 250 children with hemoglobinuric severe malaria were screened and the 40 enrolled were randomly assigned paracetamol (n = 20) or tepid sponging (n = 20). The mean age was 6.54 (2.61) years. The mean time to renal recovery in the paracetamol group was 0.491 h (95% CI, -9.265 to 10.248; p = 0.921) longer than the control group within 48 h, but this difference was not…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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