Recruiting
Phase 3

Melatonin

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05084196

Conditions

Acute Kidney Injury

Adverse Drug Event

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Melatonin

Placebo Capsule

Study Details

Brief summary:

This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.

Conditions

Acute Kidney Injury

Adverse Drug Event

Study ID

NCT05084196

Start date

Jun 5, 2023

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Aged 18 to 75 years
  • Currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status. Because of the critical nature of starting empiric broad-spectrum antibiotics, we will allow one dose of the antibiotic combination before consent and enrollment. This strategy is necessary for the ethical conduct of the study.

Exclusion criteria:

  • Estimated creatinine clearance < 30 mL/min
  • Liver impairment (liver enzymes > 3 times upper limit)
  • Any 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
  • Clinical evidence of significant unstable or uncontrolled illness which, in the opinion of the research team, could confound the results of the study or put the patient at undue risk.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Melatonin Arm

Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

placebo comparator: Placebo Arm

Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

Interventions

Melatonin

Melatonin 5 mg capsule by mouth at bedtime

Placebo Capsule

Placebo capsule by mouth at bedtime

Primary outcome measure

  • Acute kidney injury [ Time Frame: From date of randomization until the date of first documented acute kidney injury or date of antibiotic discontinuation, whichever came first, assessed up to 28 days ]

Central Contacts and Locations

Central contacts

Luigi Brunetti, PhD

908-595-2645luigi.brunetti@rutgers.edu

Locations

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Pinki Bhatt, MD

732-235-2898pb518@rwjms.rutgers.edu

Robert Wood Johnson University Hospital Somerset

Recruiting

Somerville, New Jersey, United States, 08876

Contacts

Luigi Brunetti, PhD

2016385868brunetti@pharmacy.rutgers.edu

Principal Investigator:

Luigi Brunetti, PhD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 17, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-12-17.