This protocol addresses patients with clinically manifest, metastatic American mucosal leishmaniasis (ML) involving the naso-oropharyngeal mucosa, without laryngeal or pharyngeal involvement and without increased risk for respiratory obstruction.
All persons with clinically manifest, metastatic American ML warrant systemic antileishmanial therapy. The primary goals are preventing significant morbidity — including disfigurement — and potentially life-threatening complications such as aspiration pneumonia or respiratory obstruction.
Management is built around systemic antileishmanial therapy. Several agent classes are employed — including pentavalent antimonials, polyene antifungals, and an oral option — with selection guided by individual patient factors. The complete regimen, including agent selection criteria, dosing, duration, and monitoring, is available in the full protocol.
The primary endpoint is clinical cure of mucosal disease — resolution of mucosal lesions assessed by clinical criteria. Patients require follow-up beyond the first year, as the majority of relapses occur within that window.