View clinical trials related to Visceral Leishmaniasis.
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.
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
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.
The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess the association between malnutrition and visceral leishmaniasis (VL). It was conducted in Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical, anthropometric, biochemical, immunological, parasitological and sociodemographic data of school age children from VL high prevalence communities were collected in December 2009, May 2010 and February 2011.
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of visceral leishmaniasis.
The overall objective of this trial is to identify a safe and effective treatment for visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients. Patients will receive either Ambisome alone or Ambisome in combination with Miltefosine. Patients who do not undergo treatment failure will be given a VL prophylactic treatment with Pentamidine one month after the end of the study treatment.
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.