Background Cutaneous leishmaniasis (CL) in Ethiopia, caused by Leishmania aethiopica, is often severe and hard to treat compared to CL caused by other species elsewhere. Miltefosine is the only oral anti-leishmanial drug, with a favorable side-effect profile compared to routinely available sodium stibogluconate (SSG), but evidence about its use for L. aethiopica is lacking. Methodology and principal findings In an observational cohort study, treatment outcomes, safety and adherence among CL patients who required systemic treatment and received miltefosine for 28 days in Boru Meda Hospital and University of Gondar Hospital were studied. Patient cure was defined as 100% flattening for non-ulcerated lesions and 100% flattening and 100% re-epithelization for ulcerated lesions. Outcomes were documented for day 28, 90 and 180, both per site, and pooled, adjusting for site as a fixed effect with effect coding. Among 94 included patients (32 in Gondar, 62 in Boru Meda), median lesion duration was 12 months, median size six cm, and mucosal involvement (46.8%) and diffuse (30.9%) lesions were common. Adherence to miltefosine was good, and side-effects were tolerable. Initial outcomes at day 28 were promising, with 68.8% and 94.0% of patients having good improvement or cure in Gondar and Boru Meda respectively. In Boru Meda, outcomes were good with 72.7% and 72.9% cure at day 90 and day 180 respectively. In Gondar, results were less promising, with only 12.5% and 26.7% cure at day 90 and day 180, although confidence intervals were wide. In pooled estimates, 48.7% of patients reached cure at day 180, and 32.3% relapsed. Outcomes were better in Boru Meda Hospital, for smaller lesions and for mucosal lesions. Conclusions/Significance Based on miltefosine’s good initial response, tolerable side-effects, tablet-form, we propose to include miltefosine for future clinical trials using extended treatment schedules, combination therapy, or targeting specific subgroups. Trial registration ClinicalTrials.gov NCT04004754.
Access to safe water, sanitation, and hygiene (WASH) is critical for preventing the spread of neglected tropical diseases (NTDs) including leprosy. WASH-related transmission factors remain largely unexplored in the leprosy transmission cycle. The aim of this project is to better understand WASH exposures among leprosy cases through a case-control study in North Gondar, Ethiopia. We hypothesized that leprosy cases were more likely to have inadequate WASH access and were more likely to have concurrent schistosomiasis, as schistosomiasis immune consequences may facilitate leprosy infection. Forty leprosy cases (forty-one controls) were enrolled, tested for Schistosomamansoni, administered a demographic and WASH survey, and assigned a WASH index score. WASH factors significantly associated with leprosy on adjusted analyses included open defecation (aOR = 19.9, 95% CI 2.2, 176.3) and lack of access to soap (aOR = 7.3, 95% CI 1.1, 49.9). S. mansoni was detected in 26% of participants and in stratified analysis those with leprosy had a 3.6 (95% CI (0.8, 15.9)) greater odds of schistosomiasis in districts bordering the lake, compared to 0.33 lower odds of schistosomiasis in districts not bordering the lake (95% CI (0.09, 1.2)). Overall, results suggest that leprosy transmission may be related to WASH adequacy and access as well as to schistosomiasis co-infection.
A fast agglutination screening test (FAST) for the detection of Leishmania antibodies in human serum samples was evaluated under harsh field conditions in northern Ethiopia. Test performance was compared with a standard serological test, namely the direct agglutination test (DAT), and with parasitology. In total, 103 suspected cases were recruited for the study. Based on parasitological examination, 49 patients were confirmed of having visceral leishmaniasis (VL) and the other 54 suspected cases were parasitologically negative. Field evaluation of FAST was possible in blood samples of 89 patients. FAST had 4 false negative results and 13 false positive results. DAT had 2 false negative results and 20 false positive results. A good degree of agreement (86.9%) was observed between FAST and DAT (kappa value 0.73). In this field-based evalauation, the sensitivity and specificity of FAST were found to be 91.1% (95% CI 77.9-97.1) and 70.5% (95% CI 54.6-82.8), respectively, compared with 95.3% (95% CI 82.9-99.2) and 62.3% (95% CI 47.9-74.9) for DAT. FAST had a high predictive value of a negative test, demonstrating that FAST could be utilised to exclude rapidly non-VL patients from a large population of suspects with fever and splenomegaly in endemic areas.
Background Ethiopia has over 3,200 new cases of leprosy diagnosed every year. Prevention remains a challenge as transmission pathways are poorly understood. Susceptibility and disease manifestations are highly dependent on individual host-immune response. Nutritional deficiencies, such as protein-energy malnutrition, have been linked to reduced cell-mediated immunity, which in the case of leprosy, could lead to a higher chance of active leprosy and thus an increased reservoir of transmissible infection. Methodology/Principal findings Between June and August 2018, recently diagnosed patients with leprosy and individuals without known contact with cases were enrolled as controls in North Gondar regional health centers. Participants answered survey questions on biometric data, demographics, socioeconomic situation, and dietary habits. Descriptive statistics, univariate, and multivariate logisitic regression examined associations between undernutrition, specifically body mass index (BMI), middle upper arm circumference (MUAC), and leprosy. Eighty-one participants (40 cases of leprosy, 41 controls) were enrolled (75% male) with an average age of 38.6 years (SD 18.3). The majority of cases were multibacillary (MB) (90%). There was a high prevalence of undernutrition with 24 (29.6%) participants underweight (BMI <18.5) and 17 (21%) having a low MUAC. On multivariate analysis, underweight was significantly associated with leprosy (aOR = 9.25, 95% CI 2.77, 30.81). Also found to be associated with leprosy was cutting the size of meals/skipping meals (OR = 2.9, 95% CI 1.0, 8.32) or not having enough money for food (OR = 10, 95% CI 3.44 29.06). Conclusions/Significance The results suggest a strong association between leprosy and undernutrition, while also supporting the framework that food insecurity may lead to undernutrition that then could increase susceptibility to leprosy. In conclusion, this study highlights the need to study the interplay of undernutrition, food insecurity, and the manifestations of leprosy.
BackgroundDespite extensive control measures and a declining number of human reservoirs, the incidence of leprosy in excess of 200,000 new cases each year suggests that alternative pathways of transmission may play a role in continued endemicity. Parasitic coinfection and limited water, sanitation, and hygiene (WASH) have been suggested to predispose individuals to Mycobacterium leprae infection and were further explored in this study.MethodsLeprosy cases and uninfected controls were recruited from areas around North Gondar, Ethiopia throughout 2019. Participants completed dietary and WASH surveys in addition to providing stool for helminth microscopic diagnosis and urine for Schistosoma mansoni Point-of-care circulating cathodic antigen (POC-CCA)™ rapid diagnostic testing. A similar methodology was employed for a case–control study of leprosy previously conducted by our research team in North Gondar from May to October of 2018. To more comprehensively evaluate associations between the above exposures and leprosy, data from the present 2019 study and the previous 2018 study were combined in select multivariate logistic regression analyses.ResultsA total of 47 men (59%) and 33 women (41%) participated in this study with an average age of 40 (SD 15.0 years). Most leprosy cases were multibacillary (93%). There was a high prevalence of parasitic coinfection among both cases (71%) and controls (60%). WASH insecurities were also widespread. On multivariate analysis, lack of soap for handwashing [aOR= 2.53, 95% CI (1.17, 5.47)] and the lack of toilet facilities [Adjusted odds ratio (aOR)= 2.32, 95% CI (1.05, 5.12)] were significantly associated with leprosy. Positive directionality was identified for a number of other inputs, including helminth infection [aOR= 3.23, 95% CI (0.85, 12.35)].ConclusionsTaken together, these findings strengthen previous research conducted in 2018 implicating poor WASH conditions as a driver of leprosy infection. Leprosy remains the leading infectious cause of disability in the world. As such, future research should explore the above susceptibilities in more depth to curtail the global burden of disease.
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