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Malaria clinical trials

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NCT ID: NCT04558528 Completed - Malaria Clinical Trials

Innovation Platform

Start date: October 1, 2020
Phase:
Study type: Observational

In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.

NCT ID: NCT04558515 Completed - Malaria Clinical Trials

Automated Microscopy Evaluation Study

AutoMic
Start date: February 1, 2020
Phase:
Study type: Observational

Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise. To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features. In this study, a prospective evaluation of miLabâ„¢ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.

NCT ID: NCT04546633 Recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria

KALUMI
Start date: February 16, 2021
Phase: Phase 2
Study type: Interventional

This study aims to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of age) with uncomplicated P. falciparum malaria. There is an unmet medical need for anti-malarial treatment with a new mechanism of action to reduce the probability of developing resistance.

NCT ID: NCT04545905 Completed - Malaria Clinical Trials

Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso

Start date: September 22, 2020
Phase:
Study type: Observational

Burkina Faso will be deploying next-generation ITNs through mass campaigns in pre-determined provinces. As part of New Nets Project's initiative to catalyze the market introduction of next-generation ITNs, enhanced surveillance activities will be conducted to support observational impact analyses. As part of this enhanced surveillance, malaria infection prevalence is being measured through annual cross-sectional surveys during peak transmission periods using rapid diagnostic tests (RDTs) in children aged 6 to 59 months (under 5 years). It will also include strengthened routine data collection at all health facilities in the districts. The present study aims to leverage the planned cross-sectional surveys and strengthened routine data conducted by the New Nets Project in three of the study districts (Banfora, Gaoua, and Orodara) to assess (1) whether the malaria infection prevalence data collected during antenatal care (ANC) surveillance correlates with these estimates of community infection prevalence in children 6 to 59 months and (2) if intervention coverage data (particularly ITN ownership and use) collected from ANC surveillance are valid and representative of the population as a whole. These additional data could catalyze a new model of surveillance for malaria, and greatly simplify evaluation of the impact of new interventions, as ANC surveillance could potentially replace or supplement cross-sectional household surveys and provide more granular and timely data. All pregnant women attending first ANC visit at seven health facilities in each study district and who are 20 years old or older or in a union will be eligible for enrollment. Potential participants will be approached during their visit by a health facility worker. During group counselling sessions at initial intake, women will be informed of this pilot surveillance activity, and written informed consent will be obtained from each woman individually prior to routine ANC testing. All consenting women attending ANC first visit at a participating health facilities will be tested for malaria using an RDT and asked to complete a study questionnaire which will include questions about the participant's net use, and care seeking behavior. It is expected to take 15 minutes to complete. Women who test positive for malaria will be given treatment according to national guidelines. There is no additional benefit to individual participants. The specific objectives of this ANC surveillance pilot are to: 1. Determine the prevalence of malaria infection and coverage of malaria control interventions among pregnant women attending their first ANC visit. 2. Assess the correlation between ANC surveillance parasite prevalence from this study, malaria incidence measured from health facilities, and parasite prevalence collected by the New Nets Project during cross-sectional household surveys. 3. Analyze the correlation between health seeking and net use/access in the ANC surveillance and health seeking behavior compared to the cross-sectional survey

NCT ID: NCT04529434 Recruiting - Malaria Clinical Trials

Star Homes Project 2

SHP2
Start date: January 4, 2022
Phase: N/A
Study type: Interventional

Malaria, pneumonia and diarrhoea causes a lot of illness in children in Tanzania and the study want to find better ways of protecting people against these diseases and want to find out if the type of house design can affect the general health of children living in the house.

NCT ID: NCT04516317 Completed - Severe Malaria Clinical Trials

Very Severe Malaria Treated by Intravenous Artesunate

Palustar
Start date: August 10, 2020
Phase:
Study type: Observational

In endemic areas, Plasmodium falciparum malaria exacts a huge public health toll, causing close to half a million deaths each year. In non-endemic industrialized areas, imported malaria may develop. In France, around 5000 imported cases occured annually, including 10-15% of severe malaria. The criteria for defining severe malaria in endemic areas are established by the World Health Organization (WHO), and have been adjusted for severe imported malaria. In France, in order to optimize management, severe imported malaria is separated into two groups: very severe malaria (VSM) and less severe malaria (LSM). Briefly VSM included coma and/or shock and/or respiratory failure and/or acidosis and/or hyperlactatemia and/or death during hospitalization. In France, severe imported malaria is treated with intravenous artesunate. Little is known about the management of imported VSM in the ICU with intravenous artesunate. In a French national multicentric retrospective frame, the main objective of the present study is to describe in detail: epidemiology, management, outcome and prognostic of very severe imported malaria treated with intravenous artesunate during the period 2011-2019. The second objective is to retrospectively compare two groups : VSM treated with intravenous artesunate in the ICU during 2011-2019 versus VSM treated with intravenous quinine in the ICU during 2000-2010.

NCT ID: NCT04494854 Completed - Malaria Clinical Trials

Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.

PREPAP
Start date: September 1, 2020
Phase:
Study type: Observational

The aim of this study is to analyze the perceptions, representations and expe-riences of malaria prophylaxis in patients born in endemic areas and living in France. This analysis could lead to better understanding and communication between the medical profession and patients in malaria. It would also provide patient-specific responses to their expectations, as to their families.

NCT ID: NCT04478370 Recruiting - Malaria Clinical Trials

Characterizing Humoral Immune Response to Mosquito Bites

SG6
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

The characteristics of the humoral response directed against mosquito saliva antigens are not known precisely. This is a major limitation for using immunological markers as an outcome in epidemiological trials and as an indicator for operational deployment of interventions. Recent advances in the assembly of the genome of some Anopheles and Aedes mosquito vector species has facilitated the identification of new candidate peptides in silico, using the sequences of orthologous salivary gland proteins and B-cell prediction algorithms. The objective of this study is to assess the humoral immune response directed against candidate peptides following controlled exposure to laboratory-adapted colonies of An. minimus, An. maculatus and An. dirus, Ae. aegypti and Ae. albopictus. This research will provide essential information to identify and validate immunological markers of human exposure to malaria and dengue mosquito vectors in Southeast Asia. Immunological markers would be useful to understand transmission dynamics and predict the risk of transmission as part of a surveillance system, and to assess the efficacy of vector-control interventions in entomological trials or during operational deployment of interventions in the region.

NCT ID: NCT04473768 Completed - Malaria,Falciparum Clinical Trials

Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children

DeNTS
Start date: February 1, 2021
Phase:
Study type: Observational

In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection, display high levels of antibiotic resistance and have a high case fatality rate (15%). In Kisantu hospital in the Democratic Republic of Congo (DR Congo), NTS account for 75% of bloodstream infection in children and many children are co-infected with Plasmodium falciparum (Pf) malaria. NTS bloodstream infection presents as a non-specific severe febrile illness, which challenges early diagnosis and, as a consequence, prompt and appropriate antibiotic treatment.Moreover, at the first level of care, frontline health workers have limited expertise and diagnostic skills and, as a consequence, clinical danger signs that indicate serious bacterial infections are often overlooked. Basic handheld diagnostic instruments and point-of-care tests can help to reliably detect danger signs and improve triage, referral and the start of antibiotics, but there is need for field implementation and adoption to low-resource settings. Further, it is known that some clinical signs and symptoms are frequent in NTS bloodstream infections. The integration of these clinical signs and symptoms in a clinical decision support model can facilitate the diagnosis of NTS bloodstream infections and target antibiotic treatment. The investigators aim to develop such a clinical decision support model based on data from children under five years old admitted to Kisantu district referral hospital in the Democratic republic of the Congo. While developing the model, the investigators will focus on the signs and symptoms that can differentiate NTS bloodstream infection from severe Pf malaria and on the clinical danger signs that can be assessed by handheld diagnostic instruments and point-of-care tests. The deliverable will be a clinical decision support model ready to integrate in an electronic decision support system.

NCT ID: NCT04456634 Completed - Malaria Clinical Trials

Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of Ruxolitinib With Artemether-lumefantrine

Start date: September 10, 2020
Phase: Phase 1
Study type: Interventional

Phase 1, single -center study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics& pharmacodynamics.