Effectiveness of intralesional sodium stibogluconate for the treatment of localized cutaneous leishmaniasis at Boru Meda general hospital, Amhara, Ethiopia: Pragmatic trial

Background: Cutaneous leishmaniasis (CL) is generally caused by Leishmania aethiopica in Ethiopia, and is relatively hard to treat. Sodium stibogluconate (SSG) is the only routinely and widely available antileishmanial treatment, and can be used systemically for severe lesions and locally for smaller lesions. There is limited data on the effectiveness of intralesional (IL) SSG for localized CL in Ethiopia and therefore good data is necessary to improve our understanding of the effectiveness of the treatment. Methodology/Principal findings: A pragmatic (before and after Quazi experimental) study was done to assess the effectiveness of intralesional SSG among localized CL patients at Boru Meda general hospital, Northeast Ethiopia. Patients who were assigned to intralesional SSG by the treating physician were eligible for this study. Study subjects were recruited between January and August 2021. Infiltration of intralesional SSG was given weekly to a maximum of six doses. However, when a patient’s lesions were already cured before getting 6 doses, treatment was not conintued, and patient were only asked to come for lesion assessment. Skin slit smears (SSS) were taken each week until they became negative. Outcomes were assessed at day 90, with patients who had 100% reepithelization (for ulcerative lesions) and/or flattening (for indurated lesions) defined as cured. Multi-level logistic regression was done to assess factors associated with cure. Conclusion: Our findings revealed that intralesional sodium stibogluconate resulted in a cure rate of around 60%, with almost all patients experiencing injection site pain. This emphasizes the need for local treatment options which are more patient-friendly and have better cure rates. Author summary: Cutaneous leishmaniasis (CL) is a neglected tropical disease that is quite common in Ethiopia. This is caused by Leishmania aethiopica, which results in severe lesions that do not seem to respond well to treatment. In Ethiopia, sodium stibogluconate is the most widely used treatment for leishmaniasis, but data on the effectiveness of intralesional sodium stibogluconate for localized CL is scarce. We recorded treatment outcomes and adverse events of patients with localized CL lesions who were treated with intralesional SSG up to six times with one injection administered every week. Patients were followed for 90 days, after which the cure rate was assessed. Among 83 patients enrolled, 72 were seen for outcome assessment. Less than 60% of patients were cured, despite having received at least 5 doses of treatment. Almost all patients reported injection site pain as a side-effect. The low cure rate and a high proportion of patients reporting pain indicate that intralesional sodium stibogluconate is not ideal as a treatment regimen. Cryotherapy or thermo therapy could be a better alternative, but a comparative clinical trial is needed to provide concrete evidence as to which treatment should be recommended.