Using melatonin to prevent kidney injury in hospitalized patients
Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury
This study is testing if melatonin can help prevent kidney injury in hospitalized patients who are receiving antibiotic treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT05084196 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of melatonin in preventing acute kidney injury associated with antibiotic treatment in hospitalized patients. Participants aged 18 to 75 who are prescribed vancomycin will be randomly assigned to receive either melatonin or a placebo daily. The study will monitor patients throughout their hospitalization or until they stop taking broad-spectrum antibiotics. The primary and secondary outcomes will be assessed by the research team to determine the impact of melatonin on kidney health.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 18 to 75 who are prescribed vancomycin for at least three days.
Not a fit: Patients with severe kidney or liver impairment, those requiring mechanical ventilation, or those with a history of acute kidney injury in the past 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients at risk of kidney injury due to antibiotic use.
How similar studies have performed: While the use of melatonin for kidney protection is a novel approach, previous studies have shown promising results in related areas, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Brunswick, New Jersey and 1 other locations
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (Recruiting)
- Robert Wood Johnson University Hospital Somerset — Somerville, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Luigi Brunetti, PhD — Rutgers, The State University of New Jersey
- Study coordinator: Luigi Brunetti, PhD
- Email: luigi.brunetti@rutgers.edu
- Phone: 908-595-2645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.