Clinical trial

Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury

Name

Pro2021001502

Description

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

Trial arms

Trial start

2023-06-05

Estimated PCD

2026-06-01

Trial end

2026-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Melatonin

Melatonin 5 mg capsule by mouth at bedtime

Arms:

Melatonin Arm

Placebo Capsule

Placebo capsule by mouth at bedtime

Arms:

Placebo Arm

Size

300

Primary endpoint

Acute kidney injury

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

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

Updated at

2023-12-18

1 organization

1 product

2 indications

Organization

Rutgers, The State University of New Jersey

Product

Melatonin

Indication

Acute Kidney Injury

Indication

Adverse Drug Event