View clinical trials related to Leishmaniasis, Visceral.
Filter by:This study will evaluate the of the loop-mediated amplification assay (LAMP) as a diagnostic as well as a Test-of-Cure (ToC) for visceral leishmaniasis (VL) in an endemic area in Ethiopia. Furthermore, we aim to further development of the direct-blood PCR-Nucleic Acid Lateral-Flow Immuno-Assay (dB-PCR-NALFIA) as a novel diagnostic tool for VL and its subsequent evaluation in the field.
This study will evaluate how the test medicine DNDI-0690 is taken up and broken down by the body and will also look at the safety and tolerability of the test medicine after a single dose. This is the first time the test medicine DNDI-0690 will be administered to humans.
According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. The main approach for VL diagnosis involves antibody detection using the rK39 rapid diagnostic test (RDT) and alternatively the direct agglutination test (DAT) to confirm clinically suspected cases. Suspected cases with negative rK39 RDT and/or DAT results are referred to facilities where examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available. Unfortunately, the diagnostic performance of rK39 in eastern Africa is suboptimal, particularly in settings with a high VL/HIV co-infection rate. A recently developed RDT, based on the recombinant antigen rK28, may overcome this problem, with studies reporting better performance than the rK39. However, data are not definitive, as studies comparing rK28 RDTs with rK39 RDT are limited. Another recently developed RDT detects immunoglobulin G1 (IgG1) specific to Leishmania and has shown promising results in the Indian subcontinent. This study aims to undertake a multi-country assessment of the performance of rK28 and IgG1 RDTs, as compared to the currently used rK39 RDT.
The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients with Visceral Leishmaniasis under fed condition
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.
Leishmaniasis is considered by the WHO as emerging and uncontrolled diseases. They are the second leading cause of death and the fourth leading cause of morbidity in tropical diseases. Leishmaniasis is parasitic reticulo-endotheliosis, the pathogenic agent of which is a flagellated protozoan belonging to the genus Leishmania. It is estimated that there are about 2 million new cases per year. Effective treatments against visceral leishmaniasis are few and resistance problems appear. To date, only a canine vaccine is available protecting dogs from the development of canine leishmaniasis to L. infantum. In man, in parallel clinical cases, leishmaniasis is characterized by a large number of asymptomatic carriers. This is the case in the Alpes-Maritimes where 50% of the inhabitants of the hinterland of Nice are carriers of the parasite. the investigators wish to study the protective immune response to the parasite and more particularly to the asymptomatic carriers. Indeed, these patients were infected with the parasite and did not develop the disease. Understanding the protective immune response in these patients against the parasite is therefore paramount in the development of a human leishmaniasis vaccine. For this purpose, the investigator wants to make an ex vivo study of the immune response of lymphocytes coming from asymptomatic carriers after stimulation by Leishmania vaccine peptides. It also wants to describe the immune response, after stimulation by these peptides, in the lymphocytes of subjects asymptomatic carriers and lymphocytes from subjects not infected with the parasite and comparing them. This study is unicentric and non-randomized. It wishes to recruit 20 asymptomatic carriers of L. Infantum and 10 uninfected subjects. They will be selected from our database. A simple blood sample will be taken. After verification by quantitative PCR and western blotting of their status towards leishmaniasis, the team will divide them into two groups (asymptomatic or healthy). Then the blood samples will be sent to the team of Jean Loup Lemesre of the Laboratory INTERTRYP - UMR177 of the IRD in Montpellier. ELISPOT analysis and assay of cytokines and proteases to describe the immune response of the two groups and to compare them. In addition, cell typing will be performed by flow cytometry to determine the type of lymphocytes involved in the immune response against Leishmania peptides. HLA typing will also be performed to validate the HLA coverage of the peptides tested. Finally, an analysis of the transcryptome will be carried out, which will allow to identify the differential expression of genes and metabolic pathways involved in the immune response and thus to understand how asymptomatic people can control the infection.
Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh. Since 2005 a national kala-azar elimination program is going on in the country. The program has preparatory, attack, consolidation and maintenance phases. The target of the program is to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in VL endemic upazilas of the country. The program is heading successfully to its consolidation phase. During attack phase house to house search for VL suspects and also suspects with Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly control to reduce the transmission of the disease. Since in the consolidation phase the VL case load is many times less than that in the attack phase, house to house search for VL and PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore there is a need for alternative methods for active search of VL and PKDL cases and method for sand fly control, appropriate for the consolidation phase. In the present study the investigators propose to investigate the efficacy of Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group Methods: A cluster randomized controlled design to measure sand fly density reduction at intervention household as well as sand fly mortality by entomological methods. Outcome measures/variables: reduction of sand fly density at intervention household and sand fly corrected mortality on intervention surfaces compare to control households/conditions.
This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult and children VL patients in Eastern Africa.
This is a multicenter, non-comparative, open-label clinical trial to assess the Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy and Pharmacodynamics (PD) will be assessed as secondary outcomes. The proposed study aims to assess whether drug exposure in children can be increased to equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28 days in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present study is also expected to provide the basis for minimum time to reach sufficient drug exposure for miltefosine activity to guide optimal treatment duration to be used in combination therapy for visceral leishmaniasis. The PK data will be assessed in this trial using a compartmental population PK approach.
Hypothesis: Primary hypothesis: 1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on body weight and height) for 12 weeks is safe with a cure rate of ≥95%. Secondary hypothesis: 2. Development of PKDL in children and adolescent is genetically predisposed and is associated with IL-10 & IFN-gamma gene polymorphism causing high and low serum level of IL-10 and IFN-gamma respectively. 3. Nutritional & environmental factors such as low serum vitamin E, A, D, Zn & arsenic exposure are associated with PKDL.