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New treatment option for Leptospirosis
Official title Preventive Strategies for Early and Late Complications of Leptospirosis
ClinicalTrials.gov ID: NCT07127718
What this study is testing
What is Prophylactic Plasma Transfusion?
Prophylactic Plasma Transfusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leptospirosis.
Also referred to as Prophylactic Plasma Component Transfusion, Plasma Transfusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- people with acute fever (38ºC for at least two days) and at least one of the following: myalgia, jaundice, headache, meningeal irritation, oliguria...
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- people 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...
- 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...
- HPTRT/HPCONV: SOFA SCORE less than 15
- ECMO: A Murray score of greater than or equal to 2.75
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Manila, National Capital Region, Philippines
- Quezon City, National Capital Region, Philippines
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manila, National Capital Region, Philippines; Quezon City, National Capital Region, Philippines. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.