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NOT YET RECRUITING
NCT07503600
PHASE3

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-03-26

Completion Date

2026-08-26

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Melatonin

Patients will receive oral melatonin 60 mg once daily, initiated concurrently with the administration of the colistin loading dose

OTHER

Placebo

Patients will receive matching placebo capsules following the same dosing schedule.