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

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.

Timeline

Start

2026-03-26

Primary completion

2026-08-26

Completion

2026-08-26

Publications

• Background Mansilla-Rosello A, Hernandez-Magdalena J, Dominguez-Bastante M, Olmedo-Martin C, Comino-Pardo A, Escames G, Acuna-Castroviejo D. A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in surgical patients with severe sepsis admitted to the intensive care unit. J Pineal Res. 2023 Mar;74(2):e12845. doi: 10.1111/jpi.12845. Epub 2022 Dec 2.

Drugs

Indications