View clinical trials related to Leishmaniasis, Visceral.
Filter by:Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance. In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.
Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To control the disease in these three countries a National kala-azar elimination program is ongoing. One of the major pillars of the elimination program is VL vector control. Currently there is a no public VL vector control program in Bangladesh. In India the program is depending on Indoor Residual Spraying with insecticides. IRS with DDT and in Nepal on Alpha-cypermethrin. The sand fly, vector of VL is already resistant to DDT and hurdles related with IRS i.e. funds, logistics and human resources make IRS unsustainable VL vector control method in Nepal. Thus alternative to IRS for VL vector control is highly desirable for the success of national kala-azar elimination program in these three countries. Through current research activities we will compare the effectiveness of three effective VL vector control methods. They are 1) Plastering of household walls with lime (a traditional method known in the study areas),treatment of possible sand-fly breeding places with lime and bleaching powder; 2) Installing durable wall lining containing deltamethrin in the main living room(s) of households; 3) Impregnation of existing bed-nets with slow release insecticide tablet containing deltamethrin. The study finding will be important for the national elimination program of the three countries through discovering the most effective VL vector control method.
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.
Background: - Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also affect the blood and immune system. One possible treatment for VL involves an experimental drug called SCH708980, which may help to prevent the immune system from becoming suppressed and worsening the VL. Researchers want to give the drug along with AmBisome(Registered Trademark), which kills the parasites, to see if it is a safe and effective treatment. Objectives: - To study the safety and effectiveness of SCH708980, alone and combined with AmBisome(Registered Trademark), as a treatment for visceral leishmaniasis. Eligibility: - Individuals 18 to 60 years of who have been diagnosed with visceral leishmaniasis in the past 4 to 5 days, are HIV-negative, and are willing to stay in the hospital for 30 days. - All participants will come from and be treated at the Kala-Azar Medical Research Center in Muzaffarpur, India. Design: - This is a two-part study. Participants will be assigned to only one part of the study. - Participants will be screened with a medical history and physical exam; blood, urine, and stool samples, spleen or bone marrow samples; spleen measurements; a chest xray; and a heart function test. - Part 1 participants will be separated into two groups: a larger group will have a selected dose of the study drug followed by AmBisome 7 days later, and a smaller group will have a placebo treatment followed by AmBisome. - Part 2 participants will have either the study drug or a placebo plus AmBisome, based on the test results from the Part 1 participants. - All participants will be monitored in the hospital for 30 days, and will have the following tests: - Regular blood samples - Urine and stool samples (day 14) - Spleen measurements (days 8, 14, 21, and 30) - Spleen or bone marrow sample (day 30 only). Participants who still have VL symptoms will give another sample on day 45. - At 6 months after the start of treatment, participants will have a follow-up visit with spleen measurements, blood and stool samples, and possible spleen or bone marrow samples
Visceral leishmaniosis (VL) is widely reported in Ethiopia, with about 30% of cases being associated with human immunodeficiency virus (HIV). In absence of antiretroviral treatment (ART), poor prognosis, high mortality and high relapse rates are characteristic of Ethiopian VL patients with HIV co-infection. Conversely, co-infection can be successfully managed via a combination of effective treatment of the initial episode, timely ART and prevention of relapses. Actually, until cellular immunity returns with ART, the patient is at risk of VL relapses, which can result in death, severe illness, reduced ART efficacy, drug-resistance and possibly transmission of drug-resistant Leishmania donovani. Patients most vulnerable to relapses are those with high levels of immunosuppression, with previous VL episodes, or with opportunistic infections (OIs). The most important factor to prevent relapses seems to be the clearance of visible parasites. Limited studies in Europe show that HIV co-infected patients may benefit from secondary prevention with antimonials (part of mainstay treatment for VL in Ethiopia) and pentamidine (PM), not used for VL treatment in Africa. Such maintenance treatment has not been studied in African VL, but the poor outcomes without secondary prevention highlight a need of better care to patients at risk of relapse. This prospective cohort study aims at documenting the patient's outcomes of secondary prophylaxis with PM in VL-HIV co-infection, in terms of time to relapse or death, safety and feasibility, before it can be considered for general use in Ethiopia. A placebo group is not included, due to the clear advantages of the intervention to the patient population.
The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30 days).
This study is aimed to compare the efficacy and safety of medications currently used in Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a combination of meglumine plus the liposomal amphotericin B formulation. The study is designed to demonstrate the difference in efficacy measured as cure rate at six months after treatment and the safety profile based on the adverse event rate observed with each intervention.
Kala azar (KA) or visceral leishmaniasis (VL) is endemic in several districts of Bangladesh with the highest incidence in Mymensingh, Pabna and Tangail districts. ICDDR,B is involved in a project for improving the surveillance of KA in Trishal, Mymensingh since 2005. Improvement of case detection is necessary for both surveillance purposes and better control. The aims of this pilot study are to assess some newer techniques for diagnosis of KA using blood and urine samples of suspected cases; and evaluate response to treatment with sodium stibogluconate to which resistance has been reported in India, considered to be a part of the same zone harboring the disease agent Leishmania donovani and transmitted by the same vector Phlebotomas argentipes (sand-fly). No data is currently available on response to sodium stibogluconate in KA patients in Bangladesh. Although a number of new drugs have been evaluated in the treatment of KA in India and Kenya, no trial has so far been conducted in Bangladesh. A team of researchers from GlaxoSmithKline (UK) had recently visited Bangladesh to evaluate if it would be possible to conduct a Phase-III clinical trial with sitamaquine. They interacted with scientists of ICDDR,B and expressed their interest to help develop ICDDR,B's capacity in order to include Bangladesh as one of the sites for the planned, multi-centre, Phase-III trial of sitamaquine; India and Nepal are two other possible sites for the trial. The aims of the proposed study are to train physicians and laboratory personnel in preparation for the future drug trial(s) on KA as well as to compare different tests for its diagnosis that might improve case detection at the field level and used for research purposes. The investigators will also examine in greater detail the different Leishmania species circulating in the area of Mymensingh and whether treatment failure and occurrence of Post Kala azar Dermal Leishmaniasis (PKDL) is associated with certain species.
This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.
This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.