Preventive Strategies for Early and Late Complications of Leptospirosis
NCT ID: NCT07127718
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
678 participants
INTERVENTIONAL
2024-04-12
2026-03-31
Brief Summary
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* 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
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Detailed Description
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Within the Decreasing Leptospirosis Emergence through Prognosis and Treatment Optimization (DeLEPTO) program's vision of developing tools to increase the survival of leptospirosis patients, this project will explore the avenue of novel tertiary care. Specifically, the program will look into the possibility of CFI repletion using plasma transfusion, cytokine depletion strategies using hemoperfusion (HP), and extracorporeal membrane oxygenation (ECMO). It would be interesting to see how such interventions could work individually or in a pipeline with other proposed interventions. In addition to plasma therapy, ECMO was observed to improve outcomes in severe leptospirosis. As a secondary endpoint, it would also be interesting to know if CFI can prognosticate who will benefit the most from such interventions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prophylactic Plasma Component Therapy with Conventional Treatment (PPTTRT)
This serves as the case arm for prophylactic plasma transfusion (PPT).
Participants in the PPTTRT arm will receive transfusion if the peripheral blood mononuclear cell (PBMC) complement factor I (CFI) quantitative real-time polymerase chain reaction (qPCR) deltaCT is found to be at least 25 or more. These participants will also be receiving standard of care treatment.
Participants in the PPTTRT arm with PBMC CFI qPCR deltaCT less than 25 will only be receiving standard of care treatment.
If a participant is found to have a Murray score of greater than or equal to 2.75 over the course of the hospital stay, they will undergo extracorporeal membrane oxygenation (ECMO).
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.
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
Conventional therapy
Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.
Conventional Treatment (PPTCONV)
This serves as the control arm for prophylactic plasma transfusion (PPT).
Participants in the PPTCONV arm will only be receiving standard of care treatment.
If a participant is found to have a Murray score of greater than or equal to 2.75 over the course of the hospital stay, they will undergo extracorporeal membrane oxygenation (ECMO).
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
Conventional therapy
Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.
Hemoperfusion Treatment with Conventional Treatment (HPTRT)
This serves as the case arm for hemoperfusion (HP).
Participants in the HPTRT arm will receive hemoperfusion and standard of care.
Participants with a Murray score of greater than or equal to 2.75 will undergo extracorporeal membrane oxygenation (ECMO) as a rescue treatment.
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.
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
Conventional therapy
Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.
Conventional Treatment (HPCONV)
This serves as the control arm for hemoperfusion (HP).
Participants in the HPCONV arm will only be receiving standard of care.
Participants with a Murray score of greater than or equal to 2.75 will undergo extracorporeal membrane oxygenation (ECMO) as a rescue treatment.
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
Conventional therapy
Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.
Interventions
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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.
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.
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
Conventional therapy
Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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San Lazaro Hospital, Philippines
UNKNOWN
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Philippines
UNKNOWN
Department of Science and Technology, Philippines
UNKNOWN
National Kidney and Transplant Institute, Philippines
OTHER
Responsible Party
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Romina A. Danguilan
Deputy Executive Director for Medical Services
Principal Investigators
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Romina A Danguilan, MD
Role: PRINCIPAL_INVESTIGATOR
National Kidney and Transplant Institute, Philippines
Locations
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Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila
Manila, National Capital Region, Philippines
San Lazaro Hospital
Manila, National Capital Region, Philippines
National Kidney and Transplant Institute
Quezon City, National Capital Region, Philippines
Countries
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Central Contacts
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Facility Contacts
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References
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Document Type: Study Protocol and Statistical Analysis Plan
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SJREB 2024-70
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Identifier Source: org_study_id
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