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Melatonin for Prevention of Kidney Injury

RecruitingPhase 3

Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Rutgers, The State University of New Jersey · Participants: 300 · Started: Jun 5, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05084196

Locations in the U.S.

New JerseyRobert Wood Johnson University Hospital, New Brunswick
Robert Wood Johnson University Hospital Somerset, Somerville

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.