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.
• Confirmed diagnosis of infection caused by multidrug-resistant Gram-negative bacteria based on microbiological culture and sensitivity testing
Patients receiving intravenous colistin therapy according to institutional protocols
Clinical diagnosis of sepsis or severe infection in accordance with established critical care criteria
• Pregnancy or lactation
Terminal medical or surgical illness (e.g., advanced malignancy)
Severe chronic liver disease or end-stage renal failure
Impaired cognitive function or active psychiatric illness under treatment
Parallel
Melatonin
DrugPatients will receive oral melatonin 60 mg once daily, initiated concurrently with the administration of the colistin loading dose
Placebo
Other interventionPatients will receive matching placebo capsules following the same dosing schedule.
Oxidative stress marker
serum malondialdehyde (MDA) levels
microbiological eradication
Clearance of the baseline MDR Gram-negative pathogen, confirmed by negative follow-up culture
inflammatory response
C reactive protein will be measured
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This trial is not recruiting at the moment. You can still explore other options:
