Study of Melatonin to Prevent Kidney Injury in Hospitalized Adults Receiving Antibiotics A Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of melatonin to prevent antibiotic-associated acute kidney injury in hospitalized patients. This Phase 3 interventional study focuses on patients receiving broad-spectrum antibiotics, specifically vancomycin plus piperacillintazobactam, as these medications can increase the risk of kidney injury during treatment. Participants will be randomly assigned to receive either a 5 mg melatonin capsule or a matching placebo capsule by mouth at bedtime. This treatment will continue for the duration of hospitalization or until the discontinuation of the antibiotic therapy, whichever occurs first. The study is double-blinded, meaning neither participants nor researchers know which treatment is given. During the study, participants will be followed closely throughout their hospitalization or until antibiotics stop. Researchers will monitor the occurrence of acute kidney injury from the time of randomization up to 28 days or until antibiotic discontinuation. Various health assessments will be conducted to evaluate safety and treatment effects, with the primary focus on kidney function during this period.

Melatonin for Prevention of Kidney Injury