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Malaria clinical trials

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NCT ID: NCT06155448 Active, not recruiting - Malaria Clinical Trials

Perennial Malaria Chemoprevention (PMC) Effect Study

PMCEffect
Start date: August 8, 2023
Phase: N/A
Study type: Interventional

The Malaria Consortium Nigeria (MC) will coordinate a trial of PMC in Osun State, Nigeria with strategic support from the National Malaria Elimination Programme of the Government of Nigeria (NMEP) and financial support from the BMGF. The primary purpose of the study is to provide evidence of the impact of PMC on malaria burden and related clinical outcomes, and its operational feasibility for policy decision and the inclusion of PMC into upcoming programme and funding cycles for its National Malaria Control Strategic Plan. The objectives are: 1. To evaluate the impact of PMC in children aged 2-18 months on key child health outcomes including malaria burden, hospitalisations, and anaemia. 2. To describe indicators of operational feasibility of PMC by identification and measurement of key determinants of successful uptake and implementation of PMC.

NCT ID: NCT06153862 Active, not recruiting - Malaria Clinical Trials

Africa Ready Malaria Screening

ARMS
Start date: September 23, 2022
Phase: N/A
Study type: Interventional

This study aims to develop immuno-analytical assays for testing the titres of malaria antibodies in Ghanaian patients' and/or donors' sera using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens.

NCT ID: NCT06076213 Active, not recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo

TES2022
Start date: May 1, 2023
Phase: Phase 4
Study type: Interventional

Malaria remains a public health concern, despite efforts that are invested in the disease control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the treatment of uncomplicated malaria. However, reported cases of mutations that confer to Plasmodium falciparum resistance to artemisinin (the main component of ACTs) constitute a threat to malaria control, particularly in Sub Saharan Africa. Therefore, the recommendation of the World Health Organization to conduct regularly test efficacy studies in endemic countries is paramount. The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 for the treatment of uncomplicated Plasmodium falciparum malaria in eight surveillance sites around DRC.

NCT ID: NCT05736679 Active, not recruiting - Malaria Clinical Trials

EaveTubes for Vector Control

Start date: March 23, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether In2Care EaveTubes (ETs) as a stand-alone tool can reduce malaria in an area where transmission is driven by insecticide-resistant Anopheles gambiae. Children who live in homes with ETs will be monitored for malaria infection and compared to children living in homes without ETs in Côte d'Ivoire where there is universal coverage of long lasting insecticide nets and pyrethroid resistance is high.

NCT ID: NCT05581641 Active, not recruiting - Malaria Clinical Trials

Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

Start date: December 15, 2022
Phase: Phase 1
Study type: Interventional

This first-in-human clinical trial, is a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, an ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (PfCSP). BNT165b1 will be evaluated at three dose levels (DLs) to select a safe and tolerable dose in a 3-dose schedule.

NCT ID: NCT05567016 Active, not recruiting - Malaria Clinical Trials

CHILD (Child Health and Infection With Low Density) Malaria

Start date: July 18, 2023
Phase: N/A
Study type: Interventional

This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania

NCT ID: NCT05478954 Active, not recruiting - Malaria Clinical Trials

Chemoprevention Efficacy Study in Burkina Faso

Start date: July 15, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine whether Seasonal Malaria Chemoprevention (SMC) remains effective in the health district of Nanoro in the Centre-Ouest region or Boussé in the Plateau Central region. It also aims to assess the protective efficacy of the antimalarial drugs used in SMC in the target population and to investigate levels of parasite resistance in the study districts. According to the results, this trial should provide the evidence needed to change the drugs used in SMC. A Type II hybrid effectiveness-implementation study design will be used to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the antimalarial drugs used. The study consists of two components: 1) Conducting a prospective cohort study to determine the protective efficacy of the drug combination Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) (if SPAQ provides 28 days of protection from infection) and whether drug concentrations and/or resistance influence the duration of protection; 2) Conducting a resistance markers study in symptomatic patients in the research district.

NCT ID: NCT05471544 Active, not recruiting - Malaria Clinical Trials

Effectiveness, Feasibility and Acceptability of Seasonal Malaria Chemoprevention in Aweil South County in South Sudan

Start date: July 18, 2022
Phase: Phase 3
Study type: Interventional

This study aims to explore whether SMC is an effective intervention in the context of Northen Bahr el Gazal state, South Sudan. It also aims to assess the protective efficacy of the antimalarials used in SMC in the target population and investigate levels of parasite resistance in the study counties. If successful, this trial should provide the evidence for SMC to be included in malaria programming and policy in South Sudan. A Type II hybrid effectiveness-implementation study design will be used to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the antimalarial drugs used. The study consists of five components: 1) A series of cross-sectional surveys establishing confirmed malaria cases in children; 2) A prospective cohort study to determine the protective efficacy of SPAQ (if SPAQ provides 28 days of protection from infection) and whether drug concentrations and/or resistance influence the duration of protection; 3) A resistance markers study in children 3-59 months in the research county; 4) Modelling the protective effect of SPAQ in South Sudan to determine where SMC could be a suitable malaria prevention strategy in other areas of the country, and 5) A process evaluation to understand feasibility and acceptability of the SMC intervention in South Sudan.

NCT ID: NCT05426187 Active, not recruiting - Clinical trials for Malaria in Pregnancy

Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Received Placental Malaria Vaccine

PRIMVACLongT
Start date: February 18, 2022
Phase:
Study type: Observational

Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years Sample Size: 90 Study duration: 21 months Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery. Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial Co Primary objectives - To assess the dynamics of humoral immune response to the vaccine antigen during long term follow up of the study participants - To evaluate the functional durability of the humoral immune responses of women who participated in the phase 1b vaccine trial compared to women of the same age Secondary objectives - To assess the cellular immune response during the follow-up period - To assess the incidence of clinical malaria on study participants - To assess the prevalence of Placental Malaria in study participants and adverse outcomes such as maternal anemia, low birth weight, stillbirth and prematurity.

NCT ID: NCT05354258 Active, not recruiting - Malaria Clinical Trials

Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children

MALHELMIN
Start date: June 16, 2022
Phase: N/A
Study type: Interventional

Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children