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

NCT07503600 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2026-08-26
Completion
2026-08-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07503600 on ClinicalTrials.gov