Preventing early and late complications of leptospirosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional program that measures CFI levels to see if low CFI predicts pulmonary bleeding, ARDS, or death in patients with confirmed leptospirosis. Patients with confirmed infection will be treated with conventional care and some will be randomized or selected to receive preemptive plasma transfusion or hemoperfusion, while ECMO is used for those who develop severe respiratory failure. Outcomes include the occurrence of pulmonary bleeding, ARDS, and mortality, and a secondary goal is to see whether CFI identifies who benefits most from these interventions. The trial is conducted across three tertiary centers in Metro Manila and integrates bedside interventions with laboratory prognostication.

Why it matters

Who can join: the full rules

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

Where it's running

• San Lazaro Hospital
  Manila, National Capital Region, Philippines Recruiting
• National Kidney and Transplant Institute
  Quezon City, National Capital Region, Philippines Recruiting
• Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila
  Manila, National Capital Region, Philippines Active not recruiting

Study contacts

• Principal investigator: Romina A Danguilan, MD — National Kidney and Transplant Institute, Philippines
• Study coordinator: Romina Danguilan, MD
• Email: radanguilan@gmail.com
• Phone: (63)(02)8981-0300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.