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Leishmaniasis, Cutaneous clinical trials

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NCT ID: NCT03999970 Completed - Clinical trials for Leishmaniasis, Cutaneous

A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol

FLYBITE
Start date: October 3, 2019
Phase: N/A
Study type: Interventional

The disease leishmaniasis mainly occurs in hot and tropical countries, affects millions of people and causes around 20,000 deaths across the world every year. Leishmaniasis is caused by the Leishmania parasite and is transmitted by sand flies. The parasite is tiny and not visible to the naked eye, whereas the particular sand fly is visible but small and inconspicuous. There are different types of leishmaniasis around the world and some can be very serious. They affect the skin (cutaneous leishmaniasis) or the internal organs of the body (visceral leishmaniasis). Some of the milder forms will produce skin problems which will be localised, whilst other forms of leishmaniasis will cause widespread skin changes. The skin lesions of cutaneous leishmaniasis can be disfiguring if left untreated. There are some treatments for leishmaniasis available but many of them are not easy to use or don't work well. Therefore new treatments and vaccines are needed that prevent or work against leishmaniasis. A solution being adopted for other diseases, which the investigators now wish to adopt for leishmaniasis is to develop a 'Controlled human infection model' (CHIM). These models involve deliberate exposure of individuals to an infection, in order to better understand how the disease works and to test potential vaccines and treatments. They have contributed vital scientific knowledge that has led to advances in the development of drugs and vaccines. This is an initial study using uninfected (disease-free) sand flies, taking place at the University of York. The information from this study will help us to develop a model in the future using infected sand flies so that the investigators can assess any future vaccines against Leishmaniasis. The investigators will also hold a focus group after the sand fly biting study to explore the experiences of individuals taking part in this study.

NCT ID: NCT03969134 Completed - Clinical trials for Leishmaniasis, Cutaneous

A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL

Start date: April 6, 2020
Phase: Phase 2
Study type: Interventional

This trial is designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp. Doses will be administered at a single time point.

NCT ID: NCT03929016 Completed - Clinical trials for Visceral Leishmaniasis

Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects

Start date: April 4, 2019
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT03837431 Completed - Clinical trials for Cutaneous Leishmaniases

Cutaneous Leishmaniasis Diagnostic Study

Start date: February 13, 2019
Phase:
Study type: Observational

The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.

NCT ID: NCT03829917 Completed - Clinical trials for Cutaneous Leishmaniasis, American

Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis

Start date: February 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Cure rate for L braziliensis bolivian CL has been 70%-80% for standard systemic and local monotherapies. It would benefit patients if cure rates could be consistently >90%, so testing a combination of two treatments is proposed. The most attractive systemic therapy is the only oral agent, miltefosine during 28 days, and the most attractive local therapy is application of Paromomycin cream for 28 days.

NCT ID: NCT03445897 Completed - Clinical trials for Leishmaniasis, Cutaneous

Miltefosine Plus IL Pentamidine for Bolivian CL

Start date: January 31, 2016
Phase: Phase 2
Study type: Interventional

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

NCT ID: NCT03435419 Completed - Clinical trials for Cutaneous Leishmaniases

Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan

CLeishPOCAFG
Start date: April 16, 2016
Phase: N/A
Study type: Observational

New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using more accurate and field-amenable methods.

NCT ID: NCT03303898 Completed - Clinical trials for Leishmaniasis, Cutaneous

ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE -

Asymptoleish
Start date: November 10, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03294161 Completed - Leishmaniasis Clinical Trials

Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

Start date: December 2014
Phase: Phase 2
Study type: Interventional

A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the treatment of Cutaneous Leishmaniasis in Bahia, Brazil.

NCT ID: NCT03096457 Completed - Clinical trials for Leishmaniasis, Cutaneous

Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

Start date: April 15, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.