Associated-risk determinants for anthroponotic cutaneous leishmaniasis treated with meglumine antimoniate: A cohort study in Iran

Background The control of cutaneous leishmaniasis (CL) is facilitated by knowledge of factors associated with the treatment failures in endemic countries. The aim of this evaluation was to identify the potential risk determinants which might affect the significance of demographic and clinical characteristics for the patients with anthroponotic CL (ACL) and the outcome of meglumine antimoniate (MA) (Glucantime) treatment. Methodology/Principal findings This current was executed as a cohort spanning over a period of 5 years which centered in southeastern part of Iran. Altogether, 2,422 participants were evaluated and 1,391 eligible volunteer patients with ACL caused by Leishmania tropica were included. Overall, 1,116 (80.2%) patients received MA intraleisionally (IL), once a week for 12 weeks along with biweekly cryotherapy, while 275 (19.8%) patients received MA alone (20 mg/kg/day for 3 weeks) (intramuscular, IM). The treatment failure rate in ACL patients was 11% using IL combined with cryotherapy plus IM alone, whilst 9% and 18.5% by IL along with cryotherapy or IM alone, respectively. Multivariate logistic regression model predicted 5 major associated-risk determinants including male (odds ratio (OR) = 1.54, confidence interval (CI) = 1.079-2.22, p = 0.018), lesion on face (OR = 1.574, CI = 1.075-2.303, p = 0.02), multiple lesions (OR = 1.446, CI = 1.008-2.075, p = 0.045), poor treatment adherence (OR = 2.041, CI = 1.204-3.46, p = 0.008) and disease duration > 4 months (OR = 2.739, CI = 1.906-3.936, p <= 0.001). Conclusions/Significance The present study is the original and largest cohort of ACL patients who treated with MA. A comprehensive intervention and coordinated action by the health authorities and policy-makers are crucial to make sure that patients strictly follow medical instructions. Early detection and effective therapy < 4 months following the onset of the lesion is critical for successful treatment of the patients. Since a significant number of patients are still refractory to MA, reducing man-vector exposure and development of new effective alternative drugs are essential measures against ACL due to L. tropica. Author summary Cutaneous leishmaniasis (CL) is a serious neglected tropical disease with social stigma and associated disfiguring with health burden, especially in poor endemic regions of the world. Iran is among the seven high burden CL-infected countries. Limited data are available in regarding to CL treatment and related risk determinants. Parasitologically confirmed ACL patients caused by Leishmania tropica were treated over a 5-year period (2012-2016), with IL meglumine antimoniate (MA) (Glucantime), combined with cryotherapy or with IM MA alone. The objective of this study was to identify the potential risk factors that are associated with response to treatment. The ensuing results with both therapeutic routes identified 5 major risk determinants namely male patients, lesion on face, multiple lesions, poor treatment regimen and disease duration >4 months. The extent to which medical instructions related to patients, therapy and the healthcare system should be seriously monitored. This requires multidisciplinary actions to address specific barriers which directly threaten the treatment outcome. Furthermore, early detection and prompt treatment <4 months following the disease duration together with implementations of public health education and prophylactic measures should receive priority in high risk areas.