RecruitingPhase 2

Preventive Strategies for Early and Late Complications of Leptospirosis

Philippines678 participantsStarted 2024-04-12

Plain-language 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

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Previ…

What they're measuring

Determination of CFI levels via qPCR and via ELISA

Timeframe: At baseline and Day 1 post-treatment, assessed up to study completion, an average of 3 years

Hospital Days

Timeframe: From admission to discharge from the hospital, assessed up to study completion, an average of 3 years

Occurrence of Mortality

Timeframe: 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

Timeframe: From admission to discharge from the hospital, assessed up to study completion, an average of 3 years

Trial details

NCT IDNCT07127718

SponsorNational Kidney and Transplant Institute, Philippines

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Romina Danguilan, MD

(63)(02)8981-0300 radanguilan@gmail.com

View on ClinicalTrials.gov More Leptospirosis trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determination of CFI levels via qPCR and via ELISA

Timeframe: At baseline and Day 1 post-treatment, assessed up to study completion, an average of 3 years

Hospital Days

Timeframe: From admission to discharge from the hospital, assessed up to study completion, an average of 3 years

Occurrence of Mortality

Timeframe: 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

Timeframe: From admission to discharge from the hospital, assessed up to study completion, an average of 3 years