View clinical trials related to Malaria.
Filter by:This is a cluster-randomized placebo-controlled clinical trial to evaluate the additive benefit of Ivermectin (IVM) (or Placebo) mass drug administration (MDA) to dihydroartemisinin-piperaquine (DP) MDA for malaria control in a moderate to low malaria-endemic setting as an adjunctive strategy to existing programmatic malaria control measures. The regime of DP and IVM will target both human reservoirs of Plasmodium falciparum and the Anopheles gambiae vector respectively, with the aim of interrupting transmission. The trial will be conducted on the Bijagos Archipelago, where islands (clusters) will be randomised to receive seasonal DP and IVM or DP and Placebo MDA. The primary outcome will be the prevalence of infection with Plasmodium falciparum in all age groups detected by nucleic acid amplification testing during the peak malaria transmission season after two years of intervention.
Sickle Cell Anaemia (SCA) is an inherited disease that makes the body produce red blood cells with abnormal sickle-shaped cells. The sickle-shaped cells are rigid, not flexible and break up easily resulting in anaemia. The abnormal cells also stick to the vessel walls, causing a blockage that slows or stops the flow of blood. When this happens, oxygen cannot reach nearby tissues. The lack of oxygen can cause attacks of sudden, severe pain, called pain crises, stroke or damage to important organs such as the spleen. All of these can lead to death. These attacks can occur without warning and are often started and made worse by infections such as malaria. Therefore, in many countries in Africa where malaria is common, children with SCA are given malaria medicines to prevent the infection. However, many of the medicines do not work effectively, are too difficult to take or they have side effects, resulting in poor adherence. The aim of this study is to find safe, acceptable and effective medicines for malaria prevention in children with SCA in eastern and southern Africa. The investigators propose to conduct a study to find out whether giving weekly doses of dihydroartemisinin-piperaquine, also called DP, is safe, more effective, acceptable and cost-effective than the current strategy of monthly sulphadoxine-pyrimethamine (SP) to prevent malaria in children with sickle cell anaemia. Overall, 548 children aged 6 months to 15 years will be chosen randomly to receive either weekly DP or monthly SP for about 18 months. To test if the study medicine is effective, the study will compare the case burden of malaria. The investigators will also monitor every child for any type of illness, blood transfusions and other complications of sickle cell anaemia and admissions to the hospital. In addition, the study will evaluate the impact of DP on the development of resistance by malaria parasites. The study will also include nested safety studies on the effect of DP on the heart. All study participants will receive all the other usual care and treatments, including patient education on home care, and daily penicillin if younger than 5 years. If proven safe and efficacious, chemoprophylaxis with DP may decrease the incidence of malaria in children with SCA, prevent ill-health and deaths, and improve wellbeing.
To study if a proactive strategy of weekly household visits by community health workers (CHWs) to identify people with malaria symptoms, offer diagnostic testing, and treatment for those with positive tests in Chadiza District, Eastern Province, can decrease malaria incidence and prevalence compared to conventional community case management.
Malaria remains a major public health concern in Cameroon especially among vulnerable groups such as children less than five years and pregnant women. Artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) have been used for the treatment of uncomplicated Plasmodium falciparum in Cameroon since 2004. Worldwide, several studies among children have reported high efficacy and safety of artemisinin-based combination therapies (ACTs). There is paucity of data to support the continuous use of ASAQ and AL in Cameroon. The main objective of this study is to assess the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria in the Center Region of Cameroon. A randomized, open-labelled, controlled clinical trial comparing artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) will be carried out from 5th April to 31st December, 2021 at six hospitals in the Center Region of Cameroon. The study participants shall include febrile patients aged 6 months to 10 years with confirmed uncomplicated P. falciparum infection. Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1. A minimum sample of 76 patients will be required for the study. With a 20 % increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be enrolled for each of the two study arms. The study will recruit a total of 184 patients. However, since 6 sites will be involved, a minimum of 30 participants shall be enrolled per site. Drug intake will be done under strict supervision on days 0, 1 and 2. Follow-up visits will be performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to differentiate between recrudescence and new infection.
The MiMBa (Malaria in Mothers and Babies) Pregnancy Registry aims to generate robust evidence on the safety of a range of antimalarials when used in pregnancy, particularly in the first trimester. This will be a multi-country observational study and will be deployed in several field sites in Africa.
Malaria represents a major public health concern in sub-Sahara Africa. Seasonal malaria chemoprevention (SMC) is one of the largest preventive measures. It consists to administer Amodiaquine+Sulfadoxine-Pyrimethamine to children aged 3-59 months on a monthly basis during the peak malaria transmission season. Despite its implementation, the burden of malaria is still very high in children under five years old in Burkina Faso. This raises questions about other hidden factors that can negatively affect the effectiveness of SMC intervention. Huge effort aiming at preventing human-vector contact were deployed such as the large-scale distribution of insecticide treated bed nets. Healthy humans are only infected via mosquitos if there are parasites reservoir around. Yet, there is no strategy aiming at protecting healthy humans from parasites reservoir. Under these circumstances, multiples humans sharing the same habitat could continually entertain the transmission cycle despite adequate existing measures. This would obviously jeopardize the expected impact of the SMC and the global effort to control the disease. In such context, we postulate that screening and treating malaria SMC-children's roommates could greatly improve the impact of SMC intervention and reduce malaria transmission in endemic settings. The goal of our study is to improve the impact of SMC intervention in terms of reducing malaria morbidity and mortality in children under five years. Primary objectives include assessing whether SMC + children's roommates screening and treatment with Dihydro-artemisinin-piperaquine (DHAPPQ) is more effective than current routine implementation of SMC alone as well as the assessment of the tolerance and safety of AQSP and DHAPPQ. Secondary objectives include the assessment of the impact of the new strategy on the circulating parasite population in terms of selection of resistant strains and the assessment of determinants such as adherence and acceptability of the strategy. Methodology: The study will be carried out in the Nanoro health district catchment area in Burkina Faso. This will be a randomized superiority trial. The unit of randomization will be the household and all eligible children from a household will be allocated to the same study group to avoid confusion. Households with 3 - 59 months old children will be assigned to either (i) control group (SMC alone) or (ii) intervention (SMC+ roommates screening with standard HRP2-RDT and treatment if positive) or (iii) intervention (SMC+ roommates screening with highly sensitive RDT and treatment if positive). The sample size will be 789 isolated households per arm, i.e. around 1,578 children under CPS coverage and 2,630 roommates expected. They will be followed-up for 24 months to fully cover two consecutive malaria transmission seasons and then two SMC cycles. Children will be actively followed-up during the malaria transmission seasons while in the dry seasons the followed-up will be passive. Conclusion: The project will respond to a major public health concern by providing evidence of the efficacy of a new strategy which should necessarily complement the existing ones to achieve best impact in malaria control and elimination. The project is lifesaving and could be scaled up easily at country and regional level in case of promising results. In addition, if successful, the project will reinforce the capacity of the IRSS/CRUN by offering training opportunities to young researchers.
The trial will evaluate the efficacy of ATSB deployment plus universal coverage of a WHO core vector control (VC) interventions over two transmission seasons on a minimum 30% reduction in cohort clinical disease incidence, confirmed case incidence, and parasite prevalence, as compared with VC alone. Measurement of entomological outcomes, assessment of acceptability and barriers to uptake and consistent use of ATSB, safety and adverse event monitoring and estimation of the cost and cost-effectiveness of ATSB will also occur.
The primary objective of the study is to demonstrate and quantify the protective efficacy of a single Spatial Repellent (SR) product, in reducing malaria infection in a human cohort. The study design will be a prospective cluster Randomized Control Trial (cRCT).
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available C-Reactive Protein (CRP) test kit run on a laboratory machine as a reference test for CRP.
This will be a single-centre, open label trial to determine the safety and feasibility of CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to healthy Tanzanian adults with varying prior exposure to P. falciparum.