Actively Recruiting
Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury
Led by Rutgers, The State University of New Jersey · Updated on 2025-12-17
300
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of melatonin to prevent antibiotic-associated acute kidney injury in hospitalized patients. This Phase 3 interventional study focuses on patients receiving broad-spectrum antibiotics, specifically vancomycin plus piperacillin/tazobactam, as these medications can increase the risk of kidney injury during treatment. Participants will be randomly assigned to receive either a 5 mg melatonin capsule or a matching placebo capsule by mouth at bedtime. This treatment will continue for the duration of hospitalization or until the discontinuation of the antibiotic therapy, whichever occurs first. The study is double-blinded, meaning neither participants nor researchers know which treatment is given. During the study, participants will be followed closely throughout their hospitalization or until antibiotics stop. Researchers will monitor the occurrence of acute kidney injury from the time of randomization up to 28 days or until antibiotic discontinuation. Various health assessments will be conducted to evaluate safety and treatment effects, with the primary focus on kidney function during this period.
CONDITIONS
Brief Title
Melatonin for Prevention of Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Currently prescribed vancomycin with the expectation that therapy will continue for at least 3 days based on subject status
- Allowance of one dose of the antibiotic combination before consent and enrollment due to critical nature of treatment
You will not qualify if you...
- Estimated creatinine clearance less than 30 mL/min
- Liver impairment with liver enzymes more than 3 times the upper limit
- History of allergy or contraindication to melatonin
- Pregnancy or breastfeeding
- Autoimmune disease
- Requiring vasopressors
- Requiring mechanical ventilation
- History of acute kidney injury in the past 30 days
- Inability to take oral medications
- Significant unstable or uncontrolled illness that may affect study results or pose undue risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days or until antibiotic discontinuation or hospital discharge
Participants receive melatonin 5 mg or a placebo capsule by mouth at bedtime for the duration of hospitalization or until discontinuation of broad spectrum antibiotics, whichever comes first.
Daily administration during hospitalization
Trial Site Locations
Total: 2 locations
1
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
2
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08876
Actively Recruiting
Research Team
L
Luigi Brunetti, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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