Visceral Leishmaniasis
Conditions
Interventions
This is a open-label randomized controlled two-arm clinical trial. A total of 82 patients admitted to the Institute of Tropical Diseases Nathan Portela (IDTNP) for the treatment of Visceral Leishmani
Sponsors
Instituto de Doenças Tropicais Nathan Portela - IDTNP
CIATEN - Centro de Inteligência em Agravos Tropicais Emergentes e Negligenciados
Eligibility
Inclusion criteria
Inclusion criteria: Patients with confirmed visceral leishmaniasis; both genders; without age restrictions, who agree to participate voluntarily by signing the Free and Informed Consent Term and the Minor's Assent Term, in patients aged between six and 18 years
Exclusion criteria
Exclusion criteria: Patients using anticoagulant or antiplatelet medication at the time of admission; recent diagnosis or history of thrombosis at any vascular site; congenital or acquired hemostasis disorders; need for dialysis, surgery or an invasive procedure; known or suspected hypersensitivity to any study drug; recent or past history of seizures; history of dengue fever or Severe Acute Respiratory Syndrome Coronavirus 2 infection in the last 30 days; having received specific anti-Leishmania treatment in the last 90 days; having received antifibrinolytic treatment in the last 48 hours or blood products in the last 360 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to detect a 50% reduction in the disseminated intravascular coagulation score in the first seven days of treatment for visceral leishmaniasis using the score recommended by the International Society of Thrombosis and Hemostasis (ISTH), which has the following four components: number of platelets (quantity/mm3), D-dimer dosage (µg/L), Prothrombin activity time-TAP) (seconds) and fibrinogen dosage (mg/dL) | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to detect a difference of 50% in the improvement of inflammation parameters verified by the reduction in serum levels of C-reactive protein, by reducing the levels of cytokines interferon gamma (IFN-?), interleukin six (IL-6), interleukin one beta (IL-1B), CXCL8 chemokine, interleukin 10 (IL-10), interleukin 12 (IL-12) and Tumor Necrosis Factor alpha (TNF-a) and 50% reduction in fibrinolysis with reduced dimer levels D | — |
Countries
Brazil
Contacts
Public ContactCarlos Costa
Instituto de Doenças Tropicais Nathan Portela - IDTNP
Outcome results
None listed