Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT07127718
Eligibility Criteria:
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 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 \<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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07127718
Study Brief:
Protocol Section:
NCT07127718