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Malaria clinical trials

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NCT ID: NCT06225297 Not yet recruiting - Malaria Clinical Trials

Evaluation of a Package of Interventions to Reduce the Burden of Malaria in the Urban Daaras of Touba, Senegal

Start date: January 2024
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the effectiveness of the use of adapted insecticide-treated mosquito nets combined with extended DHA-PQ-based seasonal chemoprevention for all ages and behavior change communication in reducing the burden of malaria in relation to standards of protection and care among students (taalibés) in the daaras (Koranic schools) of Touba, Senegal.

NCT ID: NCT06182176 Not yet recruiting - Malaria Clinical Trials

Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control

MALHELMIN
Start date: May 27, 2024
Phase: N/A
Study type: Interventional

Malaria remains a major health problem, especially among children living in sub-Saharan Africa where more than 90% of the disease and deaths occur. Adding to this high burden among the children is the co-existence of parasitic worms in their intestines and urinary tract. The combined infection of malaria and parasitic worms in these children has additive adverse effects of anaemia, poor physical and cognitive development, and death. Existing control programmes for the parasitic worms are operating sub-optimally despite the 2012 London Declaration on Neglected Tropical Diseases (NTDs) 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 as the London Declaration on NTDs has achieved more than 75% treatment coverage and prevented 75-85% of cases of uncomplicated and severe malaria in children. The remarkable success of SMC has led to the recent WHO recommendation for its extension to other at-risk age groups and in highly seasonal malaria transmission settings outside the Sahel region. This encouraging development supports the need to explore the possibility of integrating helminth control programmes with other successful delivery platforms such as SMC. However, limited empirical evidence exists on an integrated approach that integrated the control of malaria and parasitic worms in a safe, acceptable, easy-to-deliver and effective manner. To address this knowledge gap, the investigators conducted a randomised controlled trial in the first stage of this project to establish the feasibility and safety of integrating helminth control with SMC among Senegalese children. This second stage will assess the effectiveness and cost-effectiveness of using SMC platform to deliver deworming drugs to preschool and school-aged children living in communities where the burden of malaria and parasitic worms is high in central Ghana. One thousand, two hundred children aged 1-14 years will be randomly assigned equally to two study communities where antimalarial (SMC) drugs and deworming drugs will be administered in combination to the children living in one study community, and antimalarial (SMC) drugs alone will be delivered to the children living in the second study community. The effectiveness of the combined delivery will be determined by checking whether the combined antimalarial and deworming drugs prevent anaemia in the children who receive the combined drugs compared to the children who receive antimalarial drugs only. We will also determine the cost and cost-effectiveness of this approach by estimating the incremental cost savings due to cases of moderate and severe anaemia averted by giving antimalarial and deworming drugs together to the children. The findings of this study would provide evidence to boost public health recommendations for an integrated control of malaria and parasitic worms among children living in the poorest countries of the world. The findings may also reinforce the empirical evidence that the future direction of healthcare systems in developing countries should be comprehensive health management rather than vertical management of a single disease.

NCT ID: NCT06179732 Completed - Malaria Clinical Trials

Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities

Start date: June 5, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial. By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.

NCT ID: NCT06173206 Not yet recruiting - Malaria Clinical Trials

Parasite Clearance and Protection From Infection (PCPI) in Cameroon

Start date: May 15, 2024
Phase: Phase 3
Study type: Interventional

The Cameroon PCPI study will measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP. The total number of participants is expected to be 900 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 450 children will be assigned to the SP group, 250 to the SPAQ group, and 200 to the AS group. The results of this study will allow to measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP.

NCT ID: NCT06172686 Not yet recruiting - Clinical trials for Controlled Human Malaria Infection

In-vivo Transmission Model in Semi-immune Adults

Start date: January 9, 2024
Phase: Phase 1
Study type: Interventional

Controlled human malaria infection (CHMI) has revolutionized the development of malaria vaccines. It involves the administration of either known numbers of sporozoites or infected erythrocytes to healthy human volunteers under a controlled environment. The use of highly sensitive molecular malaria diagnostic methods informs treatment decisions before symptom development and allows the characterization of parasite growth dynamics. Sporozoite CHMI has safely been used in six countries in Africa providing a platform to assess the efficacy of candidate malaria vaccines and study the natural immunity to malaria. Blood stage CHMI involves administration of known number of Artemether Lumefantrine sensitive infected erythrocytes in healthy volunteers, and it is a more sensitive model for modelling parasite growths and study the efficacy of blood-stage malaria vaccines. It has been safely used in Australia and Europe but not in Africa. Adaptation of this model by administration of combination of suboptimal and optimal antimalarial drugs lead to increased gametocytaemia, and infection rates in mosquitoes following standard membrane feeding assay. Such adaptation allows the model to be used to study parasite transmission from human to mosquitoes and evaluate transmission blocking malaria interventions. There is an urgent need to establish an in vivo model for early-stage clinical evaluation of transmission blocking interventions (TBI) in volunteers living in malaria endemic countries. This would allow rapid and cost-effective way to down-select transmission blocking candidate malaria vaccine and gametocidal antimalarial drugs before larger, more complex, and expensive field efficacy studies are conducted. A study done in naïve individual showed 100% success in establishing a malaria infection using 2800 P. falciparum infected RBCs, while a recent study (manuscript in development) has demonstrated success in establishing infection in Tanzanian semi-immune individuals with low malaria exposure using 1000 P. falciparum infected RBCs. We will use 1000 ALU-sensitive 3D7 P. falciparum infected RBCs to establish an in vivo transmission model for studying Transmission blocking interventions and assess the efficiency of two antimalarial drugs regimens (Piperaquine and doxycycline) to induce high levels of gametocytaemia and mosquito infection rates in healthy African adults. We will also investigate the determinants of successful transmission to mosquitoes including underlying immune responses to both asexual and sexual malaria antigens, asexual parasite dynamics and gametocyte burden, sex ratio of male and female gametocytes, and the relationship between gametocyte density and mosquito infection rate

NCT ID: NCT06166498 Not yet recruiting - Malaria Clinical Trials

Parasite Clearance and Protection From Infection (PCPI) in Zambia

Start date: February 15, 2024
Phase: Phase 3
Study type: Interventional

The Zambia PCPI study will measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP. The total number of participants is expected to be 600 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 400 children will be assigned to the SP group and 200 to the AS group. The results of this study will allow to measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP.

NCT ID: NCT06162078 Recruiting - Clinical trials for Maternal Malaria During Pregnancy - Baby Not Yet Delivered

Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida

EPI-PAM
Start date: August 25, 2023
Phase:
Study type: Observational [Patient Registry]

The overarching aims of this study are to longitudinally determine the occurrence of pregnancy in a cohort of nulligravida at the community level and to estimate the burden of malaria infection during the course of the pregnancy till delivery.

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: NCT06148792 Not yet recruiting - Vivax Malaria Clinical Trials

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

TADORE
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question[s] it aims to answer are: - is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) - is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) - is the tolerability and safety of TQRevised acceptable - is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.