💬In plain words
What the trial is, and whether it could suit you
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 antibiotic
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
* 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 less than 8 at present. Participant has had chest compressions or CPR
* Pregnancy
* PPTTRT/PPTCONV: Requiring emergent dialyses
* 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
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