Preventing early and late complications of leptospirosis
Decreasing Leptospirosis Emergence Through Prognosis and Treatment Optimization (DeLEPTO) Project 1: Preventive Strategies for Early and Late Complications of Leptospirosis
We will test whether measuring complement factor I (CFI) can predict who will develop lung damage from leptospirosis and whether treatments—plasma transfusion, hemoperfusion, or ECMO—help people with complicated leptospirosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 678 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | National Kidney and Transplant Institute, Philippines Academic / other |
| Locations | 3 sites (Manila, National Capital Region and 2 other locations) |
| Trial ID | NCT07127718 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2 interventional program that measures CFI levels to see if low CFI predicts pulmonary bleeding, ARDS, or death in patients with confirmed leptospirosis. Patients with confirmed infection will be treated with conventional care and some will be randomized or selected to receive preemptive plasma transfusion or hemoperfusion, while ECMO is used for those who develop severe respiratory failure. Outcomes include the occurrence of pulmonary bleeding, ARDS, and mortality, and a secondary goal is to see whether CFI identifies who benefits most from these interventions. The trial is conducted across three tertiary centers in Metro Manila and integrates bedside interventions with laboratory prognostication.
Who should consider this trial
Good fit: People with acute, laboratory-confirmed leptospirosis who have fever and compatible symptoms and who meet site criteria (for example, not yet ventilator-dependent for prophylactic arms, with dialysis-requiring AKI considered for the hemoperfusion arm) are eligible.
Not a fit: Patients with mild leptospirosis that is resolving without complications, those without laboratory confirmation, or those already on prolonged mechanical ventilation or with irreversible organ failure are unlikely to benefit from the tested interventions.
Why it matters
Potential benefit: If successful, using CFI to guide early plasma or hemoperfusion and timely ECMO could reduce pulmonary bleeding, ARDS, and deaths from leptospirosis.
How similar studies have performed: ECMO has been reported to improve outcomes in severe leptospirosis in prior case series, while plasma repletion and hemoperfusion for cytokine or complement modulation are less well studied and remain largely experimental in this disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Manila, National Capital Region and 2 other locations
- Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila — Manila, National Capital Region, Philippines (Active_not_recruiting)
- San Lazaro Hospital — Manila, National Capital Region, Philippines (Recruiting)
- National Kidney and Transplant Institute — Quezon City, National Capital Region, Philippines (Recruiting)
Study contacts
- Principal investigator: Romina A Danguilan, MD — National Kidney and Transplant Institute, Philippines
- Study coordinator: Romina Danguilan, MD
- Email: radanguilan@gmail.com
- Phone: (63)(02)8981-0300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.