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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Philippines
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila
ACTIVE_NOT_RECRUITING
Manila
San Lazaro Hospital
NOT_YET_RECRUITING
Manila
National Kidney and Transplant Institute
RECRUITING
Quezon City
Contact Information
Primary
Romina Danguilan, MD
radanguilan@gmail.com
(63)(02)8981-0300
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2026-03
Participants
Target number of participants: 678
Treatments
Experimental: 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).
Active_comparator: 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).
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: National Kidney and Transplant Institute, Philippines
Collaborators: Department of Science and Technology, Philippines, Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Philippines, San Lazaro Hospital, Philippines

This content was sourced from clinicaltrials.gov

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