Preventive Strategies for Early and Late Complications of Leptospirosis
ConditionLeptospirosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Kidney and Transplant Institute, Philippines
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prophylactic Plasma Transfusion
- Hemoperfusion
- Extracorporeal Membrane Oxygenation
- Conventional therapy
Treatment groups
678 Participants
are divided into 4 treatment groupsSponsors and collaborators
National Kidney and Transplant Institute, Philippines
Lead sponsor
San Lazaro Hospital, Philippines
Collaborator
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Philippines
Collaborator
Department of Science and Technology, Philippines
Collaborator
Source ClinicalTrials.gov