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Sleep hormone may shield kidneys from antibiotic harm

NCT ID NCT05084196

Prevention Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether melatonin, a common sleep aid, can prevent kidney damage in hospitalized patients who need a strong antibiotic called vancomycin. About 300 adults aged 18 to 75 will receive either melatonin or a placebo alongside their antibiotic. The goal is to see if melatonin reduces the risk of acute kidney injury, a serious side effect of this treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute kidney injury Drug-Related Side Effects and Adverse Reactions acute tubulointerstitial nephritis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Adverse drug event

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Robert Wood Johnson University Hospital Somerset

    RECRUITING

    Somerville, New Jersey, 08876, United States

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