This protocol applies to patients with clinically manifest, metastatic American mucosal leishmaniasis of the naso-oropharyngeal mucosa — without laryngeal or pharyngeal involvement and without increased risk of respiratory obstruction — in whom first-line systemic antileishmanial therapy has not achieved mucosal cure.
The patient has clinically manifest, metastatic American mucosal leishmaniasis involving the naso-oropharyngeal mucosa, with no laryngeal or pharyngeal involvement and no increased risk of respiratory obstruction. All persons in this situation should receive systemic antileishmanial therapy, given the goals of preventing morbidity — such as disfigurement — and mortality from complications such as aspiration pneumonia or respiratory obstruction.
First-line systemic antileishmanial therapy was administered but did not achieve the required treatment goal: clinical cure of the mucosal disease (resolution of mucosal lesions), as assessed by clinical criteria. The majority of relapses occur within the first year. This protocol defines the management step that follows that failure.
Depending on the clinical setting, options may include reinduction with the initially used agent or a switch to a different therapeutic approach. Combination strategies are also among the considerations. The complete regimen selection criteria, sequencing, and clinical algorithm are available in the full structured protocol.
Clinical cure of the mucosal disease — resolution of mucosal lesions — assessed by clinical criteria.
DOI: 10.1093/cid/ciw670
All persons with clinically manifest, metastatic, American ML should receive systemic antileishmanial therapy, with the goals of preventing morbidity (eg, disfigurement) and mortality (eg, from aspiration pneumonia or respiratory obstruction).
In some settings, reinduction therapy with the agent initially used may be justified.
Alternatives to consider for some persons/settings include monotherapy with a different medication or, potentially, combination therapy, such as with pentoxifylline.
In a double-blind, placebo-controlled clinical trial, conducted in an L. (V.) braziliensis–endemic area (Bahia State) among persons with nasal ML, all 11 persons who received a 30-day course of combination therapy with parenteral SbV (20 mg/kg/day) plus oral pentoxifylline (400 mg thrice daily) were classified as cured, without relapse during approximately 2 years of follow-up, compared with 7 of 12 (58%) persons who received SbV therapy plus placebo.
Response to antileishmanial treatment of ML typically is assessed by clinical criteria.
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