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| Name | Class |
|---|---|
| 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 |
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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:
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:
This study aims to determine the clinical utility of complement factor I (CFI) as a prognosticator in patients with complicated leptospirosis without severe pulmonary complications and to determine if its guidance to preemptive measures can lead to a reduction in adverse clinical outcomes, specifically the occurrence of pulmonary bleeding and acute respiratory distress syndrome (ARDS), and mortality. Hence, the results of the study may lead to novel treatment approaches that can be readily applied in clinical practice. The decision to provide preemptive non-invasive therapies or early intensive care admission could lead to significant breakthroughs in managing the disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Plasma Component Therapy with Conventional Treatment (PPTTRT) | Experimental | 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). |
|
| Conventional Treatment (PPTCONV) | Active Comparator | 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). |
|
| Hemoperfusion Treatment with Conventional Treatment (HPTRT) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic Plasma Transfusion | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of CFI levels via qPCR and via ELISA | Baseline blood samples will be obtained for CFI qPCR and ELISA upon enrollment. Post-treatment blood samples will be obtained for ELISA. Correlation of values of qPCR results to ELISA data will be performed using Pearson correlation (r2 of 0.80 or higher will be considered highly correlated). Test for concordance using Kendall's W will be done. | At baseline and Day 1 post-treatment, assessed up to study completion, an average of 3 years |
| Hospital Days | Hospital days will be computed from the date of admission to the date of discharge. Mortality or discharge against medical advice will be penalized with a maximum stay of at least 30 days. | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Occurrence of Mortality | Mortality is defined as death occurring to be related to the natural course of the present condition of leptospirosis or its complication, but not more than two weeks upon discharge by attending physician after being assessed as well recovered, or the like. | From admission to discharge from the hospital or date of death, assessed up to study completion, an average of 3 years |
| Presence of Significant Pulmonary Involvement | As in leptospirosis (Weil's syndrome) plus evidence of pulmonary injury as indicated by (1) the need for mechanical ventilator support, (2) P/F ratio <200,(3) gross hemoptysis, OR (4) chest x-ray result consistent with leptospirosis-related pulmonary changes. | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Renal Replacement Therapy | Number of days requiring dialysis during hospital stay. | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Need for Inotropic Support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romina Danguilan, MD | Contact | (63)(02)8981-0300 | 1004 | radanguilan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Romina A Danguilan, MD | National Kidney and Transplant Institute, Philippines | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila | Active, not recruiting | Manila | National Capital Region | 1000 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23543869 | Background | Milhem MM, Knutson T, Yang S, Zhu D, Wang X, Leslie KK, Meng X. Correlation of MTDH/AEG-1 and HOTAIR Expression with Metastasis and Response to Treatment in Sarcoma Patients. J Cancer Sci Ther. 2011 Dec 29;S5(4):004. | |
| 33048966 | Background | Popugaev KA, Bakharev SA, Kiselev KV, Samoylov AS, Kruglykov NM, Abudeev SA, Zhuravel SV, Shabanov AK, Mueller T, Mayer SA, Petrikov SS. Clinical and pathophysiologic aspects of ECMO-associated hemorrhagic complications. PLoS One. 2020 Oct 13;15(10):e0240117. doi: 10.1371/journal.pone.0240117. eCollection 2020. |
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The patient information will not be shared at present as the study is still ongoing and there is intellectual property involved. However, general IPD, such as age, sex, and affliction, will be shared, together with important clinical outcomes such as mortality and incidence of renal and or pulmonary complications, only after appropriate intellectual property protection.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2026 | Apr 7, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2026 | Apr 7, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D007922 | Leptospirosis |
| ID | Term |
|---|---|
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D006464 | Hemoperfusion |
| D015199 | Extracorporeal Membrane Oxygenation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| Conventional Treatment (HPCONV) | Active Comparator | 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. |
|
|
|
| Hemoperfusion | Device | 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 | Device | 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:
Criteria for weaning:
|
|
|
| Conventional therapy | Other | Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary. |
|
|
Number of days requiring inotropic support to attain MAP >65 and number of days requiring each inotrope
| From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Need for Emergent Invasive Respiratory Support | Inability to maintain Sp02 >92% on maximum non-invasive respiratory support | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Presence of Refractory Hypotension | Occurrence of systolic blood pressure less than 90 mm Hg, OR mean arterial pressure less than 65 mm Hg, OR a decrease of 40 mm Hg in systolic blood pressure compared to baseline: unresponsive to crystalloid fluid challenge of 20 to 40 mL/kg OR requiring vasopressor support | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Presence of Significant Renal Involvement | As in leptospirosis (Weil's syndrome), plus evidence of severe acute kidney injury as indicated by the need for emergency dialysis due to intractable acidosis, hyperkalemia, uremic encephalopathy or pericarditis. | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Need for Extracorporeal Membrane Oxygenation (ECMO) assessed via Murray score | A participant is considered for Extracorporeal Membrane Oxygenation (ECMO) when he/she attains a Murray score of greater than or equal to 2.75. The Murray score is a scale used to assess the severity of acute lung injury in acute respiratory distress syndrome (ARDS). A Murray score of 0 means there is no lung injury; a score of 0.1-2.5 means there is mild to moderate lung injury; and a score of greater than 2.5 means there is severe lung injury. | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Need for Extracorporeal Membrane Oxygenation (ECMO) assessed via Horowitz Index for Lung Function (P/F Ratio) | A participant is considered for Extracorporeal Membrane Oxygenation (ECMO) when he/she attains the a Horowitz Index for Lung Function (P/F Ratio) of less than 200. The Horowitz Index for Lung Function (P/F Ratio) is the ratio of arterial oxygen partial pressure (PaO2) and the fractional inspired oxygen (FiO2). A P/F ratio of greater than 300 mmHg indicates absence of ARDS; 201-300 mmHg is mild ARDS; 101-200 mmHg is moderate ARDS; and less than or equal to 100 is severe ARDS. | From admission to discharge from the hospital, assessed up to study completion, an average of 3 years |
| Intensive Care Unit (ICU) Days | Number of days patient is required to stay in ICU (date out of ICU will be date ordered by the attending physician) | From admission into ICU to date out of ICU, assessed up to study completion, an average of 3 years |
| San Lazaro Hospital | Recruiting | Manila | National Capital Region | 1003 | Philippines |
|
| National Kidney and Transplant Institute | Recruiting | Quezon City | National Capital Region | 1100 | Philippines |
|
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| D007239 | Infections |
| D013514 | Surgical Procedures, Operative |
| D012138 | Respiratory Therapy |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |