Clinical Trial

The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections

Not Yet Recruiting Phase 3
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Summary
This study evaluates whether adding melatonin to standard colistin therapy improves outcomes in patients with multidrug-resistant (MDR) Gram-negative bacterial infections. These infections are difficult to treat and are associated with high morbidity and mortality, particularly in critically ill patients. Colistin is often used as a last-line antibiotic for these infections; however, its effectiveness may be limited, and it is associated with side effects such as kidney injury. Melatonin, a naturally occurring hormone, has antioxidant, anti-inflammatory, and immune-modulating properties that may enhance the effectiveness of antibiotics and reduce treatment-related complications. In this randomized, double-blind, placebo-controlled study, adult patients receiving colistin will be assigned to receive either melatonin or a placebo in addition to standard care. The study will assess whether melatonin improves oxidative stress, infection control, and clinical outcomes while maintaining safety.
Trial Details
NCT Number NCT07503600
Lead Sponsor Ain Shams University
Conditions Multidrug-Resistant Gram-Negative Bacterial Infections, Antimicrobial Resistance
Enrollment 70 participants
Start Date 2026-03-26
Primary Completion 2026-08-26 (estimated)
Study Completion 2026-08-26 (estimated)
Updated on ClinicalTrials.gov 2026-03-31