Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07127718

PHASE2

Preventive Strategies for Early and Late Complications of Leptospirosis

Sponsor: National Kidney and Transplant Institute, Philippines

View on ClinicalTrials.gov

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

Official title: Decreasing Leptospirosis Emergence Through Prognosis and Treatment Optimization (DeLEPTO) Project 1: Preventive Strategies for Early and Late Complications of Leptospirosis

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

678

Start Date

2024-04-12

Completion Date

2026-03

Last Updated

2025-08-17

Healthy Volunteers

Conditions

Leptospirosis

Interventions

BIOLOGICAL

Prophylactic Plasma Transfusion

ABO/Rh-type compatible fresh frozen plasma (FPP) units will be thawed to 37° prior to administration. Plasma transfusion will be administered intravenously, 1 unit for 4 hours every 12 hours. There will be two consecutive days for the transfusion for a total of 4 units.

DEVICE

Hemoperfusion

The hemoperfusion (HP) procedure will follow the standard procedure of National Kidney and Transplant Institute (NKTI) using Jafron HA330 hemoperfusion cartridge. First, an internal jugular catheter is attached to the patient. Alternatively, an arteriovenous fistula or arteriovenous graft may be placed on the patient. The patient will then be hooked to a hemodialysis machine. Blood pump speed will be set to 150-200mL/min, and HP will last for 2 to 2.5 hours. Whole blood will flow through the sorbent HA330 cartridge and back to the patient. Anticoagulation is not necessary due to the short treatment time. Hemoperfusion will be repeated after 12-24 hours for at least three days.

DEVICE

Extracorporeal Membrane Oxygenation

A veno-venous ECMO (VV ECMO) will be applied by aseptically inserting a venous cannula into the femoral veins. The patients will be hooked to an ECMO machine. Patients without significant bleeding or vascular intervention will be managed with an activated clotting time set at 140-180 sec by 800-1000 U/h of heparin. Otherwise, heparin will be titrated to maintain a partial thromboplastin time of 60-80 sec. ECMO settings are as follows: * Mean blood pressure of \>60 mm * SaO2 at \>90% with a flow of 3.5-4.5 L/min * Hematocrit at \>35% * Platelets \>50000-100000/mL * Transfusions will be done when necessary Criteria for weaning: * ABG: * pH 7.35-7.45 * PaO2 \>80 mm Hg * PCO2 \<45 mm Hg * Under the following conditions: * Gas blender FiO2 of 0.21 * Sweep gas of 0 L/min at an ECMO flow of 2 L/min * Ventilator mode (if applicable): * FiO2 of 0.6 * Tidal volume of 6 mL/kg * PEEP of 8 cmH2O * RR of 12-16/min for VV ECMO or 3 L/min of O2 via nasal prong with awakening ECMO patients

OTHER

Conventional therapy

Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.

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 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 \<8 at present. Participant has had chest compressions or CPR * Pregnancy * PPTTRT/PPTCONV: Requiring emergent dialyses * PPTTRT/PPTCONV: Significant renal impairment as defined by eGFR less than 30 * 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

Locations (3)

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

Manila, National Capital Region, Philippines

San Lazaro Hospital