Preventive Strategies for Early and Late Complications of Leptospirosis

Recruiting now · Phase 2

Conditions studied: Leptospirosis

In brief

The goal of this clinical trial is to learn if complement factor I (CFI) works to predict development of complications in participants with leptospirosis. It will also learn if plasma transfusion, hemoperfusion, and extracorporeal membrane oxygenation works to treat participants with leptospirosis. The main questions it aims to answer are: * Does a low level of CFI predict the development of lung damage in participants with leptospirosis? * Does plasma tranfusion lower the chances of participants getting lung damage from leptospirosis? * Does hemoperfusion work to remove harmful materials from the blood of participants with leptospirosis? * Does extracorporeal membrane oxygenation increase the chance of survival in participants with lung damage? Researchers will compare plasma tranfusion and hemoperfusion to conventional therapy (standard of care for leptospirosis, including antibiotics, fluids, and other treatment that the doctor deems necessary) to see if these novel therapies work to treat leptospirosis. Participants will: * Give blood samples for the study of CFI * Receive conventional therapy and/or plasma transfusion for 4 times in 2 days, OR * Receive conventional therapy and/or hemoperfusion for at least 3 days, AND/OR * Receive extracorporeal membrane oxygenation if their condition worsens

Key facts

Study ID: NCT07127718
Run by: National Kidney and Transplant Institute, Philippines
People needed: 678
Starts: 2024-04-12
Expected to finish: 2027-03-01
Last updated by the study team: 2026-04-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

San Lazaro Hospital — Manila, National Capital Region, Philippines (enrolling)
National Kidney and Transplant Institute — Quezon City, National Capital Region, Philippines (enrolling)
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila — Manila, National Capital Region, Philippines

Full record on ClinicalTrials.gov

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