Actively Recruiting
Preventive Strategies for Early and Late Complications of Leptospirosis
Led by National Kidney and Transplant Institute, Philippines · Updated on 2026-04-13
678
Participants Needed
3
Research Sites
150 weeks
Total Duration
On this page
Sponsors
N
National Kidney and Transplant Institute, Philippines
Lead Sponsor
S
San Lazaro Hospital, Philippines
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Preventive Strategies for Early and Late Complications of Leptospirosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Acute fever of 38°C for at least two days plus at least one of the following: muscle pain, jaundice, headache, meningeal irritation, low urine output, or red eyes
- Positive leptospirosis test by microscopic agglutination test (MAT) with titer ≥1:400, or positive latex agglutination test, or positive IgG/IgM lateral flow test, or positive PCR, or positive blood culture
- For plasma transfusion or conventional therapy groups: no need for ventilator support
- For hemoperfusion groups: acute kidney injury requiring dialysis or vasopressor support after fluid resuscitation with a SOFA score less than 15
- For ECMO group: Murray score ≥2.75
You will not qualify if you...
- History of chronic kidney disease or ongoing dialysis
- Diseases causing coughing up blood such as bronchiectasis
- Blood disorders, cancer, severe heart disease, HIV infection, cavitary pulmonary tuberculosis, liver cirrhosis, or severe malnutrition (weight under 35 kg)
- Recent cardiac arrest or current coma with Glasgow Coma Scale less than 8
- Pregnancy
- For plasma transfusion or conventional therapy groups: requiring emergency dialysis, significant lung disease (P/F ratio less than 300 or obvious respiratory distress), severe neurological symptoms, low blood pressure or need for vasopressors, or unstable circulation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila
Manila, National Capital Region, Philippines, 1000
Active, Not Recruiting
2
San Lazaro Hospital
Manila, National Capital Region, Philippines, 1003
Actively Recruiting
3
National Kidney and Transplant Institute
Quezon City, National Capital Region, Philippines, 1100
Actively Recruiting
Research Team
R
Romina Danguilan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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