Active clinical trials for "Leishmaniasis"

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.

Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40% of the cases. DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to relevant drug toxicity, high morbidity due to a long lasting disease, with an important socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate than historic cure rates of pentavalent antimony in the treatment of disseminated leishmaniasis.

Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.

The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.

Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

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.

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.

A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral leishmaniasis incidence. The intervention unit is the village (400-1000 people). The study is designed to detect a 50% reduction in Leishmania donovani incidence in intervention compared to control clusters over 2 years. 24 clusters (selected as high incidence during previous years) will be randomly allocated to intervention or control. Following health education, and with informed consent, all households in intervention villages will receive free Permanets (from September 2006). Net usage will be monitored and new nets provided if required. Control villages will not be given untreated nets, as - although commonly used in this region - their effectiveness against sandflies has not been proven. Pre-intervention infection status of villagers (>2 yrs) will be evaluated serologically from finger-prick blood (and past/current disease status noted). Incident infections will be recorded by 3-monthly active search for clinical cases, and by annual serological diagnoses to detect subclinical infections. All villagers (>2yrs) will be leishmanin skin tested at the end of the trial for further subclinical infection detection, and sera from a sub-sample will be tested for antibodies to sandfly saliva antigens (a measure of sandfly exposure). All clinical cases will be given free treatment. Free Permanets will be provided to control villages after the trial. Complementary studies involve entomological surveillance by light traps in a sample of houses and social/economic questionnaire surveys. The entomological surveys will test whether community-wide use of LLINs provides any mass effect, which could protect those in the community who fail to use LLIN for any reason.

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 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.