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Background: Treatment guidance for children and older adult patients affected by cutaneous leishmaniasis (CL) is unclear due to limited representation of these groups in clinical trials. Methods: We conducted a collaborative retrospective study to describe the effectiveness and safety of antileishmanial treatments in children ≤ 10 and adults ≥ 60 years of age, treated between 2014 and 2018 in ten CL referral centers in Latin America. Results: 2,037 clinical records were assessed for eligibility. Of them, the main reason for non-inclusion was lack of data on treatment follow-up and therapeutic response (182/242, 75% of children and 179/468, 38% of adults). Data on 1,325 eligible CL patients (736 children and 589 older adults) were analyzed. In both age groups, disease presentation was mild, with a median number of lesions of one (IQR: 1–2) and median lesion diameter of less than 3 cm. Less than 50% of the patients had data for two or more follow-up visits post-treatment (being only 28% in pediatric patients). Systemic antimonials were the most common monotherapy regimen in both age groups (590/736, 80.2% of children and 308/589, 52.3% of older adults) with overall cure rates of 54.6% (95% CI: 50.5–58.6%) and 68.2% (95% CI: 62.6–73.4%), respectively. Other treatments used include miltefosine, amphotericin B, intralesional antimonials, and pentamidine. Adverse reactions related to the main treatment were experienced in 11.9% (86/722) of children versus 38.4% (206/537) of older adults. Most adverse reactions were of mild intensity. Conclusion: Our findings support the need for greater availability and use of alternatives to systemic antimonials, particularly local therapies, and development of strategies to improve patient follow-up across the region, with special attention to pediatric populations. Author summary: Cutaneous leishmaniasis (CL) is a vector-borne disease caused by a parasite called Leishmania that affects more than 1 million people worldwide each year and mostly causes chronic skin ulcers. The first line treatment continues to be systemic antimonials, despite drawbacks such as numerous daily injections and toxic side effects. Some groups, including children and older adults, are usually not included in clinical trials and, therefore, specific treatment guidance for them is uncertain due to the scarcity of robust evidence. RedeLEISH, a Latin American network of leishmaniasis researchers, conducted a retrospective study of the medical records of children ≤ 10 years of age and adults ≥ 60 years of age, treated between 2014 and 2018 in ten CL referral centers in the region, with the aim of learning about and documenting the effectiveness and tolerability of routine antileishmanial treatments, and ultimately contributing to improving the management of these patient groups. Our findings, based on 1,325 eligible patients' records (589 adults ≥ 60 years of age and 736 children ≤ 10 years of age), showed that in both age groups the disease presents predominantly in a mild form, but that the most commonly used treatment, systemic antimonials, has limited effectiveness. This supports and encourages greater use of local therapies, and other treatment alternatives in these special populations. The results of this study also highlight the need to develop strategies for better follow-up of routine CL treatment and determination of effectiveness, as lack of such information was the principal criterion for exclusion of patients screened for eligibility, and less than 50% of eligible patients had information on two or more follow-up visits. [ABSTRACT FROM AUTHOR]

Background: Tegumentary leishmaniasis (TL) is a parasitic disease that can present a cutaneous or mucocutaneous clinical form (CL and MCL, respectively). The disease is caused by different Leishmania species and transmitted by phlebotomine sand flies. Bolivia has one of the highest incidences of the disease in South America and the diagnosis is done by parasitological techniques. Our aim was to describe the clinical and immunological characteristics of CL and MCL patients attending the leishmaniasis reference center in Cochabamba, Bolivia, in order to gain updated clinical and epidemiological information, to evaluate the diagnostic methods used and to identify biomarkers related to clinical disease and its evolution. Methodology/Principal findings: The study was conducted from September 2014 to November 2015 and 135 patients with lesions compatible with CL or MCL were included. Epidemiological and clinical data were collected using a semi-structured questionnaire. Two parasitological diagnostic methods were used: Giemsa-stained smears and culture of lesion aspirates. Blood samples obtained from participants were used to measure the concentrations of different cytokines. 59.2% (80/135) were leishmaniasis confirmed cases (CL: 71.3%; MCL: 28.7%). Sixty percent of the confirmed cases were positive by smears and 90.6% were positive by culture. 53.8% were primo-infections. Eotaxin and monokine induced by IFN-γ presented higher serum concentrations in the MCL clinical presentation compared to CL cases and no-cases. None of the cytokines presented different concentrations between primo-infections and secondary infections due to treatment failure. Conclusions/Significance: In Bolivia, parasitological diagnosis remains the reference standard in diagnosis of leishmaniasis because of its high specificity, whereas the sensitivity varies over a wide range leading to loss of cases. Until more accurate tools are implemented, all patients should be tested by both smears and culture of lesion aspirates to minimize the risk of false negatives. Our results showed higher concentrations of several cytokines in MCL compared to CL, but no differences were observed between CL and no-cases. In addition, none of the cytokines differed between primary and secondary infections. These results highlight the need of further research to identify biomarkers of susceptibility and disease progression, in addition to looking at the local cellular immune responses in the lesions. Author summary: Tegumentary leishmaniasis is a parasitic disease caused by different Leishmania species and transmitted by phlebotomine sand flies. The disease is distributed worldwide and it can present a cutaneous or mucocutaneous clinical form. The clinical outcomes of the disease depend on factors inherent to the parasite, the vector and the host. Bolivia has one of the highest incidences of the disease in South America, where the diagnosis is mainly done by parasitological techniques. The present study was conducted from September 2014 to November 2015 with 135 patients attending the leishmaniasis reference centre in Cochabamba (Bolivia). We aimed to describe the clinical, epidemiological and immunological characteristics of leishmaniasis patients to gain knowledge on tegumentary leishmaniasis and evaluate the suitability of the diagnostic methods used. In South America, Giemsa-stained smears and the culture of lesion aspirates remain the reference standards in diagnosis because of their high specificity, however the sensitivity varies over a wide range resulting in some loss of case detection. Until more accurate tools are implemented, all patients should be screened by both tests to minimize the risk of false negatives. Additionally, for better disease management, identification of biomarkers of susceptibility and disease progression would be desirable. [ABSTRACT FROM AUTHOR]