NCT07127718 Preventive Strategies for Early and Late Complications of Leptospirosis
| NCT ID | NCT07127718 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Kidney and Transplant Institute, Philippines |
| Condition | Leptospirosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 678 participants |
| Start Date | 2024-04-12 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 678 participants in total. It began in 2024-04-12 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Romina A Danguilan, MD
PRINCIPAL INVESTIGATOR
National Kidney and Transplant Institute, Philippines
Frequently Asked Questions
Who can join the NCT07127718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Leptospirosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07127718 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07127718 currently recruiting?
Yes, NCT07127718 is actively recruiting participants. Contact the research team at radanguilan@gmail.com for enrollment information.
Where is the NCT07127718 trial being conducted?
This trial is being conducted at Manila, Philippines, Manila, Philippines, Quezon City, Philippines.
Who is sponsoring the NCT07127718 clinical trial?
NCT07127718 is sponsored by National Kidney and Transplant Institute, Philippines. The principal investigator is Romina A Danguilan, MD at National Kidney and Transplant Institute, Philippines. The trial plans to enroll 678 participants.