View clinical trials related to Malaria.
Filter by:In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent Preventive Treatment in pregnant women with Sulphadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization's recommended malaria control strategies in sub-Saharan African countries. The strategy overcomes the risk of misdiagnosis of malaria in pregnant women by treating them all with SP according to predetermined schedules, but the strategy is now threatened by the spread of Plasmodium parasite resistant strains. As a necessary alternative, Intermittent Screening and Treatment in pregnancy (ISTp), aims on the monthly screening of pregnant women with a malaria rapid diagnostic test (RDT) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. The ISTp depends on the performance of the diagnostic tests, and the use of ultrasensitive RDTs (us-RDTs), which have a higher analytical sensitivity than conventional RDTs, should improve the efficacy of the strategy. Unlike IPTp-SP, ISTp prevents overuse of antimalarials and thus limits drug pressure on malaria parasites. This advantage could be potentiated by using, for pregnant women, an ACT that is not yet used or should not be used in the field for other strata of the population. The recently approved new ACT combination, Pyronaridine - Artesunate (Pyramax®) is the ideal candidate for this purpose. This study will compare the effects of the ISTp using an us-RDT and Pyramax® (ISTp-US-Py) with the standard IPTp-SP on maternal malaria indicators (malaria infection, parasite density), maternal anemia, spontaneous abortions or intrauterine deaths during pregnancy, fetal morbidity (preterm birth, low birth weight, small for gestational age) and neonatal mortality at delivery in both study groups through conducting a randomized clinical trial enrolling second trimester pregnant women in Maternité Esengo Health Center, located in Kisenso, Kinshasa, the Democratic Republic of the Congo (DRC), a malaria perennial transmission area. The results generated from this study will be essential for the National Malaria Control Program in the selection and implementation of new malaria control policies and addresses the effectiveness of IPTp-SP decline among pregnant women in the DRC.
Bakground In Burkina Faso, since the adoption of this new malaria treatment policy in 2005, several studies evaluating the efficacy and tolerance of ACTs have been carried out by different research teams at different sites according to an irregular chronology and according to different methods. Studies conducted in children 6 to 59 months with supervised use of ACTs indicate adequate clinical and parasitological response rates varying between 93% to 98% after correction to the PCR at day 28. With the introduction of seasonal malaria chemoprevention (SMC) by the Sulfadoxine-Pyriméthamime/amodiaquine combination in almost all health districts of Burkina Faso, ASAQ is no longer recommended for the treatment of uncomplicated malaria in the areas covered by this intervention. In 2017, DHA-PPQ was added to the national treatment guidelines as a first-line treatment option. The therapeutic efficacy study carried out in 2017-2018 by the CNRFP showed a PCR-corrected treatment failure rate of over 10% with the AL combination. However, molecular analyzes have not shown the presence of mutations at position 580 on the PfK-13 gene which is associated with resistance to artemisinin derivatives. The combination artesunate-pyronaridine (As-Pyr) was recently added to the WHO Prequalified Medicines List and Essential Medicines List. In 2019, it received regulatory marketing authorization to be used as a treatment for malaria in Burkina Faso. Burkina Faso (along with the Niangoloko and Bobo Dioulasso centers) was one of the countries where clinical trials p ar the As-Pyr association were led. This combination has been found to be effective and well tolerated in Burkina Faso. The combinations of AL and DHA-PPQ were observed to be well tolerated in previous efficacy studies. The combinations DHA-PPQ and As-Pyr could potentially replace AL as first-line treatment in Burkina Faso if the results of these planned therapeutic efficacy studies continue to show a high rate of failures with AL. The herein study aims to assess the efficacy and safety of AL, DHA-PPQ and As-Pyr in the treatment of uncomplicated malaria in children in three health districts in Burkina Faso, namely the health districts of Banfora, Nanoro and de Gourcy. This study will provide PNLP and the Ministry of Health with additional data and evidence on the safety and efficacy of these treatments against malaria in Burkina Faso. Primary objective The primary objective is to assess the clinical and parasitological efficacy of AL, DHA-PPQ and AS-Pyr in the treatment of uncomplicated P. falciparum malaria in children aged 6 months to 12 years, corrected by PCR on day 28 (AL) or 42 (DHA-PPQ & AS-Pyr). Study settings The study will be conducted at the medical center (CMA of Niangoloko, the Clinical Research Unit of Nanoro (URCN) and the medical center with surgical antenna (CMA) of Gourcy. Populations Febrile patients of both sexes aged between 6 months and 12 years with confirmed uncomplicated P. falciparum mono-infestation who wellcome for an outpatient visit to the health facilities. Procedures It will be a multicenter, randomized, open-label, three-arm study involving three sites representing the three epidemiological facies of malaria in Burkina Faso. The three therapeutic combinations (AL, DHA-PPQ and As-Pyr) will be tested in different sites with different characteristics of transmission and resistance of malaria. Children with uncomplicated malaria who meet the criteria for inclusion in the study will be recruited and treated with the combination of AL or DHA-PPQ or As-Pyr. They will be monitored for 28 days for the AL group and 42 days for the DHA-PPQ and AS-Pyr arm. The follow-up will consist of scheduled control visits during which clinical examinations and laboratory tests will be carried out. A total of 1050 children will be enrolled in the study. Main results 1. The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or adequate clinical and parasitological response. 2. The frequency and nature of adverse events. 3. The blood concentration of lumefantrine on day 7
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In line with this WHO recommendation, Rwanda Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether-lumefantrine (ALN), which has been used in Rwanda for the last 14 years) and dihydroartemisinin-piperaquine (DHA-PPQ), another WHO-approved drug for the treatment of uncomplicated malaria which, though, has not been used in Rwanda, is being considered for adoption as a second line or alternative first line treatment. The objective of this study is to inform the decisions or actions made by a public health authority (Rwanda Rwanda Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Rwanda. Jhpiego's Impact Malaria project in Rwanda, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Rwanda MOH in its effort to evaluate the efficacy of ALN and DHA-PPQ in the treatment of children with uncomplicated malaria. The study is being conducted by Rwanda MOH, with technical support and funding by PMI-USAID through Jhpiego in Rwanda.
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In line with this WHO recommendation, Kenya Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether lumefantrine (AL), and dihydroartemisinin-piperaquine (DHP), the first and second line treatment of uncomplicated malaria in Kenya. The objective of this study is to inform the decisions or actions made by a public health authority (Kenya Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Kenya. Jhpiego's Impact Malaria project in Kenya, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Kenya MOH in its effort to evaluate the efficacy of AL and DHP in the treatment of children with uncomplicated malaria. The study is being conducted by Kenya MOH, with technical support and funding by PMI-USAID through Jhpiego in Kenya.
Spatial repellents are chemical-based devices that when placed in a room, make that room non-conducive for mosquitoes. These tools can be used to help in the fight against vector borne diseases such as malaria and dengue. However, their efficacy in reducing mosquito biting and therefore malaria transmission has never been evaluated in Africa. This study will evaluate the efficacy of a spatial repellent in reducing mosquito biting on human beings and measure the impact any reduced biting will have on malaria transmission. The investigators will recruit and follow-up 5,984 children between 6 months and <10 years of age in Busia County to determine how many times they will be infected with malaria in villages where the investigators will have distributed spatial repellents and compare the rate of infection to villages where the investigators will not have distributed the repellent devices. Additionally, the investigators will measure whether the distribution of spatial repellents in one village will drive mosquitoes to their neighboring houses thereby increasing malaria transmission in those areas. The children participating in the study will be divided into 3 groups (cohorts). The first group will be followed up during the first 4 months before any intervention is distributed and the purpose here will be to determine that the villages are comparable. After this, the investigators will recruit the next group of participants and follow them up for 1 year and repeat this again for another year. During the follow-up, the children will be asked to come to the health facility where they will be tested for malaria using RDT or blood slide for microscopy. Every two weeks, a member of the study team will come to the participant's house and ask them if they had any history of fever. If the participants had fever, they will be tested for malaria. All children who turn out to be positive for malaria by RDT will be treated free of charge. At the same time, the investigators shall also perform mosquito collections to determine the impact of spatial repellents on the density of Anopheles mosquitoes.
This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) vaccinated with three doses of a synthetic derivative of the CS protein of Plasmodium vivax to determine their protective efficacy. Then volunteers will be subject to an infectious challenge (Controlled Human Malaria Infection) to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.
This study outlines a plan for conducting a routine assessment of malaria infection prevalence and intervention coverage using antenatal care (ANC) attendees. This will be a non-randomized assessment of the potential to use pregnant women attending their first ANC visit as a pragmatic sentinel population to monitor prevalence of malaria and the coverage of malaria control interventions. The use of a questionnaire, to include standard malaria rapid diagnostic testing, will be piloted with consenting women attending their first ANC visit at 21 individual health facilities across three of the New Net Project pilot study districts in western Mozambique: seven facilities each from Changara, Chemba, and Guro Districts. The results of the ANC questionnaires will be analyzed to see how well they correlate to similar malaria prevalence and intervention coverage estimates obtained during the contemporary community-based cross-sectional surveys administered during New Net Project pilot evaluation activities. As part of the New Nets Project, Mozambique is deploying next-generation ITNs through mass campaigns in pre-determined provinces. The present study aims to leverage planned New Nets Project cross-sectional surveys and strengthened routine case surveillance data in three of the study districts (Changara, Guro, and Chemba) to assess (1) whether the malaria infection prevalence data collected during ANC surveillance correlates with the cross-sectional survey 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 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 facility 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 use of insecticide-treated bed nets (ITNs) has contributed to the substantial reduction in malaria cases and deaths. This progress is threatened by increasing resistance to commonly used insecticides in important mosquito vector populations. Newly developed, next-generation ITNs that use two insecticides, or an insecticide synergist and an insecticide, are effective at killing resistant mosquitoes, but large-scale uptake of these nets has been slow due to higher costs and lack of enough evidence to support broad policy recommendations. This observational study will occur alongside a pilot distribution of next-generation ITNs in two regions of Mozambique. Over three years, data on the entomological and epidemiological impact of the different ITN types will be collected. Data collection will occur in six districts: two districts receiving the dual-active ingredient ITN Interceptor® G2 (BASF: alphacypermethrin + chlorfenapyr); one district that will receive the dual-active ingredient ITN Royal Guard® (Disease Control Technologies: alphacypermethrin + pyriproxyfen); one district receiving an ITN containing an insecticide plus an insecticide synergist , Olyset®Plus (Sumitomo Chemical: permethrin + piperonyl butoxide); and two districts receiving the standard pyrethroid-only ITNs DuraNet® (Shobikaa Impex Private Limited: alphacypermethrin). Data will be collected on malaria vector bionomics, disease epidemiology, and ITN use in order to help better demonstrate the public health value of next-generation ITNs and to support donors, policymakers, and National Malaria Control Programs in their ITN decision-making and planning processes.
This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its antimalarial efficacy, safety, and tolerability. This study also evaluates whether or not a fixed dose of the pharmacoenhancer cobicistat when given in combination with SJ733 significantly improves drug efficacy.
Optimal is a Randomized clinical trial to optimize treatment of malaria in HIV -malaria co infected patients. It has been demonstrated that, when the antimalarial drug Artemether Lumefantrine is co administered with Efavirenz based ART in HIV-malaria co-infected individuals, sub therapeutic levels of the drug are achieved hence resulting in poor malaria treatment outcomes. The study then hypothesizes that, : HIV-malaria co-infected individuals receiving efavirenz-based ART plus a double-dose or 5-day course of artemether-lumefantrine will achieve higher and adequate artemether-lumefantrine serum concentrations with adequate 42-day treatment outcomes compared to individuals with HIV-malaria co-infection receiving efavirenz-based ART plus a standard-dose of artemether-lumefantrine.