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Could a sleep hormone help fight superbugs?

NCT ID NCT07503600

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding melatonin to the strong antibiotic colistin helps patients with multidrug-resistant bacterial infections. These infections are hard to treat and often deadly. The trial will give 70 adults either melatonin or a placebo alongside their regular treatment to see if it improves infection control and reduces side effects like kidney damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin
What this could lead to
If it works, this could point toward a simple, safe way to boost the effectiveness of last-resort antibiotics for hard-to-treat infections.
What could go wrong
This is a small, early-stage trial with only 70 participants. The results may not apply to all patients, and melatonin might not provide significant benefit over placebo.

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 70 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

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 70 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: * • Confirmed diagnosis of infection caused by multidrug-resistant Gram-negative bacteria based on microbiological culture and sensitivity testing * Patients receiving intravenous colistin therapy according to institutional protocols * Clinical diagnosis of sepsis or severe infection in accordance with established critical care criteria Exclusion Criteria: * • Pregnancy or lactation * Terminal medical or surgical illness (e.g., advanced malignancy) * Severe chronic liver disease or end-stage renal failure * Impaired cognitive function or active psychiatric illness under treatment * Known hypersensitivity to melatonin * Use of melatonin within 48 hours prior to enrollment

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Conditions

The condition(s) this trial relates to.

gram-negative bacterial infections

As listed by the trial registrant

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

Antimicrobial resistance Multidrug-resistant gram-negative bacterial infections

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.