From the Guidelines
Leishmaniasis is a diverse group of syndromes caused by protozoa of the genus Leishmania, and its treatment depends on the type and severity of infection, with the primary goals of therapy being to prevent mortality and morbidity, as outlined in the 2016 clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH) 1.
Diagnosis of Leishmaniasis
Diagnosis of leishmaniasis typically involves identifying the parasite through microscopic examination of tissue samples, blood tests for antibodies, PCR testing to detect parasite DNA, or culture methods. The diagnosis is often made based on the clinical presentation, which can vary depending on the species of Leishmania and the immune response of the host.
- Cutaneous leishmaniasis (CL) is the most common syndrome worldwide and is characterized by skin lesions that typically ulcerate after weeks to months.
- Mucosal leishmaniasis (ML) is a less common presentation that can cause destructive lesions of the naso-oropharyngeal/laryngeal mucosa.
- Visceral leishmaniasis (VL) is a potentially life-threatening condition that requires prompt evaluation and treatment, as it can disseminate throughout the reticuloendothelial system and occasionally affect other organ systems.
Treatment of Leishmaniasis
The treatment of leishmaniasis can be challenging, and the primary goals of therapy are to prevent mortality and morbidity, with the only US Food and Drug Administration (FDA)–approved medications being intravenous liposomal amphotericin B (L-AmB) for VL, and oral miltefosine for CL, ML, and VL caused by particular species 1.
- For CL, treatment options include topical paromomycin, local heat therapy, cryotherapy, or systemic medications like miltefosine (2.5 mg/kg/day for 28 days) or amphotericin B (3-5 mg/kg/day for 15-20 days).
- For VL, treatment with liposomal amphotericin B (3 mg/kg/day for 5-10 days) is recommended, as it has a high response rate and can prevent mortality.
- The therapeutic strategy depends on the infecting species, the severity of infection, and the patient's immune status, with the objective of treatment being clinical healing, not parasitologic cure.
- Patients should be monitored for treatment response and potential side effects, which can include kidney damage, heart problems, or liver dysfunction depending on the medication used.
From the FDA Drug Label
Leishmaniasis is a disease caused by Leishmania species, which can cause visceral, cutaneous, or mucosal leishmaniasis. Visceral leishmaniasis is characterized by clinical signs and symptoms such as fever, splenomegaly, and cytopenia, confirmed by the presence of Leishmania amastigotes in aspirates of spleen or bone marrow. Cutaneous leishmaniasis is characterized by skin ulcers with a minimum area of 50 mm^2, parasitologically confirmed, without mucosal involvement. Diagnosis of leishmaniasis is made by detecting Leishmania amastigotes in aspirates of spleen or bone marrow (for visceral leishmaniasis) or by parasitological confirmation of skin ulcers (for cutaneous leishmaniasis). Treatment of leishmaniasis includes oral miltefosine (IMPAVIDO) for 28 consecutive days, with dosages based on weight: * 30 kg to 44 kg: one 50 mg capsule twice daily with food * 45 kg or greater: one 50 mg capsule three times daily with food The efficacy of miltefosine in the treatment of leishmaniasis has been evaluated in clinical trials, with final cure rates of 94% for visceral leishmaniasis and definite cure rates for cutaneous leishmaniasis 2, 2, 2.
Key points:
- Diagnosis: Detection of Leishmania amastigotes in spleen or bone marrow aspirates (visceral) or parasitological confirmation of skin ulcers (cutaneous)
- Treatment: Oral miltefosine (IMPAVIDO) for 28 days, with weight-based dosing
- Efficacy: Final cure rates of 94% for visceral leishmaniasis and definite cure rates for cutaneous leishmaniasis
From the Research
Definition and Transmission of Leishmaniasis
- Leishmaniasis is a vector-borne disease caused by protozoan parasites of the genus Leishmania, transmitted by phlebotomine female sand flies of the genera Phlebotomus and Lutzomyia 3, 4.
- The disease can cause visceral (VL), cutaneous (CL), and mucocutaneous (ML) forms, with over 20 well-recognized Leishmania species known to infect humans 3.
Diagnosis of Leishmaniasis
- Diagnosis of leishmaniasis previously relied on invasive techniques, but now serological tests using the recombinant kinesin antigen (rK39) and molecular methods (polymerase chain reaction) are considered the best options 3.
- Other diagnostic techniques include direct microscopic examination, enzyme-linked immunosorbent assay, latex agglutination, and immunochromatographic strip testing 5, 6.
Treatment of Leishmaniasis
- Therapy for leishmaniasis ranges from local treatment of cutaneous lesions to systemic therapy for disseminated CL, ML, and VL 3.
- Agents with efficacy against leishmaniasis include amphotericin B, pentavalent antimonial drugs, paromomycin, and miltefosine 3, 7, 6.
- However, no single therapy for VL currently offers satisfactory efficacy along with safety, and the growing resistance to traditional treatments has compelled scientists to search for new efficient compounds 3, 6.