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Can plasma transfusion and blood filtering save lives in leptospirosis?

NCT ID NCT07127718

Disease control Sponsor: National Kidney and Transplant Institute, Philippines 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether plasma transfusion and a blood-filtering procedure called hemoperfusion can prevent lung damage and death in people with leptospirosis, a bacterial infection spread by animals. Researchers will also check if a blood marker called CFI can predict who will get severe complications. About 678 participants will receive either standard care or one of the experimental treatments.

What this could mean

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

Active substance
Plasma transfusion and hemoperfusion
What this could lead to
If successful, this could provide new treatments to prevent severe lung damage and improve survival in leptospirosis patients.
What could go wrong
This is a Phase 2 trial, so the treatments are still experimental. They may not work better than standard care, and there are risks like allergic reactions or bleeding from plasma transfusion.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 678 people

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

Started

Apr 2024

Expected to finish

Mar 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 60 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: * Subjects with acute fever (38ºC for at least two days) and at least one of the following: myalgia, jaundice, headache, meningeal irritation, oliguria, conjunctival suffusion * Who have a microscopic agglutination test (MAT) that indicates a single serum sample MAT titer greater than or equal to 1:400 * Or a positive result for the latex agglutination test or a repeat test after seven days * Or a positive result for Leptospira IgG/IgM lateral flow immunochromatographic test (ICT) or a repeat test within 3-14 days after the baseline test * Or a positive result for Leptospira polymerase chain reaction (PCR) * Or a positive blood culture of leptospira WITHOUT the complication specified in a subgroup of interest * PPTTRT/PPTCONV: Not requiring ventilator support * HPTRT/HPCONV: Dialysis Requiring Acute Kidney Injury. Defined as KDIGO Acute Kidney Injury Stage 3 or requiring renal replacement therapy to correct intractable acidosis, electrolyte abnormality, or over uremic encephalopathy or pericarditis * HPTRT/HPCONV: Vasopressor Requiring - The subject must have received intravenous fluid resuscitation of a minimum of 30ml/kg within 24 hours of eligibility and still with hypotension (blood pressure less than 90/60, MAP less than 65) requiring vasopressor support * HPTRT/HPCONV: SOFA SCORE less than 15 * ECMO: A Murray score of greater than or equal to 2.75 Exclusion Criteria: * Previous diagnosis of chronic kidney disease or on maintenance dialysis * Previous diagnoses of diseases associated with hemoptysis, such as bronchiectasis * Blood dyscrasias, malignancy, severe heart disease, HIV, cavitary PTB, Cirrhosis by ultrasound, severe malnutrition (Weight of less than 35kg) * Post cardiac arrest or those with GCS less than 8 at present. Participant has had chest compressions or CPR * Pregnancy * PPTTRT/PPTCONV: Requiring emergent dialyses * PPTTRT/PPTCONV: Significant lung pathology as defined by P/F ratio less than 300, or obvious respiratory distress * PPTTRT/PPTCONV: Presence of severe neurological symptoms * PPTTRT/PPTCONV: Hypotension (or need for vasopressor support) * PPTTRT/PPTCONV: Ongoing hemodynamic instability

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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

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

  • Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila

    ACTIVE_NOT_RECRUITING

    Manila, National Capital Region, 1000, Philippines

  • National Kidney and Transplant Institute

    RECRUITING

    Quezon City, National Capital Region, 1100, Philippines

  • San Lazaro Hospital

    RECRUITING

    Manila, National Capital Region, 1003, Philippines

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