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Can a simple Five-Step protocol save leptospirosis Patients' kidneys?

NCT ID NCT05425524

Disease control Sponsor: Chulalongkorn University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 02, 2026 · Last updated Oct 02, 2026

Summary

Leptospirosis is a bacterial infection spread through water contaminated by animal urine, and it can lead to serious kidney damage. Researchers at Chulalongkorn University are testing a five-step hospital care bundle for adults admitted with suspected leptospirosis. The bundle guides doctors through rapid testing, antibiotics within an hour of blood cultures, intravenous fluids, and staged management of kidney injury. The trial measures whether patients who receive the bundle have less acute kidney injury in the first 72 hours than those who receive usual care.

What this could mean

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

Active substance
a five-step hospital care bundle for leptospirosis
What this could lead to
If the bundle works, hospitals could adopt a standard set of steps that helps protect leptospirosis patients from acute kidney injury.
What could go wrong
The trial may show the bundle does not reduce kidney injury compared with usual care. Results from one hospital setting may not apply everywhere, and the bundle adds steps that could be hard to follow consistently.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

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

Started

Oct 2019

Expected to finish

Dec 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 years and older

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: * age \> 18 years * Suspicious Leptospirosis including body temperature \> 38 celcius, Severe myalgia, and exposure to reservoir hospital of flood water. * Calf muscle tenderness * Conjunctival suffusion * Anuria or oliguria and/or proteinuria * Jaundice * Hemorrhagic manifestations (pulmonary and intestine) * Meningeal irritation * Nausea, vomiting, abdominal pain, diarrhea. * Admitted in hospital Exclusion Criteria: * other infectious disease * pregnancy

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Conditions

The condition(s) this trial relates to.

leptospirosis

As listed by the trial registrant

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

Leptospirosis

How to take part

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  1. The places running it

    1 site. 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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Chulalongkorn university

    RECRUITING

    Bangkok, Bangkok, 10330, Thailand

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