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Malaria, Falciparum clinical trials

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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: 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: NCT05197751 Active, not recruiting - Malaria,Falciparum Clinical Trials

MSP3-CRM-Vac4All/ Alhydrogel® Malaria Vaccine

MSP3CRMV4All
Start date: December 1, 2021
Phase: Phase 1
Study type: Interventional

First-in-Human, Randomised, Dose-Finding Single Center Study to evaluate three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel® : 3 µg, 10 µg and 30 µg

NCT ID: NCT04800055 Active, not recruiting - Malaria Clinical Trials

Attractive Targeted Sugar Bait Phase III Trial in Zambia

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04318002 Active, not recruiting - Malaria,Falciparum Clinical Trials

Safety and Immunogenicity of RH5.1/Matrix-M in Adults and Infants Living in Tanzania

Start date: January 25, 2021
Phase: Phase 1
Study type: Interventional

This is an age de-escalation, dose-escalation open label randomised trial studying the safety and immunogenicity of RH5.1/Matrix-M, administered intramuscularly in healthy adults, young children and infants in Tanzania

NCT ID: NCT04300309 Active, not recruiting - Clinical trials for Plasmodium Falciparum Malaria

Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

CALINA
Start date: December 21, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria.

NCT ID: NCT04280692 Active, not recruiting - Malaria,Falciparum Clinical Trials

Controlled Human Malaria Infection Transmission Model - Phase A

CHMI-TransMod
Start date: August 22, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is to develop a model to test the efficacy of vaccines and/or drugs designed to block transmission of malaria to mosquitoes and to identify the targets of transmission-blocking immunity to malaria.

NCT ID: NCT04149106 Active, not recruiting - Malaria,Falciparum Clinical Trials

Seasonal Malaria Chemoprevention With Dihydroartemisin Piperaquin vs. Sulfadoxine-pyrimethamin+Amodiaquin

Start date: July 1, 2019
Phase: Phase 3
Study type: Interventional

Seasonal Malaria Chemoprevention (SMC) for children less than five years old is one the high impact interventions against malaria in sub-Saharan Africa (SSA). Since 2016, the Government of Mali and partners through the National Malaria Control Program has deployed SMC countrywide during high malaria transmission season with a total of four (4) rounds per year. Sulfadoxine-Pyrimethamine (SP) with Amodiaquine (AQ) are the drugs used for SMC. However, SP is also used for Intermittent preventative treatment (IPTp) for pregnant women while AQ has been used for decades for treatment of uncomplicated malaria. The proposed study will examine the effect of SMC with Sulfadoxine+Amodiaquine (SP+AQ) extension to older age, the efficacy of Dihydroartemisin-Piperaquine (DHA-PQ) when used for SMC, social, cultural, economic and health systems factors associated with effective implementation of SMC. The specific aims of this study are to: 1] Assess the effect of SMC (SP+AQ) on malaria incidence and infection prevalence in different age groups across sites; 2] Study the effect of SMC (DHA-PQ) compared to SMC (SP-AQ) among children less than 10 years; 3] Determine the cost-effectiveness for each treatment regimen; ) 4] Explore factors determining effective SMC implementation including coverage of children targeted to receive treatment by community distributors, receipt of a full course of treatment, perception of medications by parents and health care providers, and sustainability; and 5) Establish a district based system to identify severe cases. The expected outcomes of this work, upon completion of our specific aims, include 1) Recommendations to Malian health officials and other partners for improving implementation of SMC and alternative drug to SP+AQ for SMC, and 2) Guidelines for routine monitoring of SMC implementation.

NCT ID: NCT04079621 Active, not recruiting - Malaria Clinical Trials

Short Course Radical Cure of P. Vivax Malaria in Nepal

Start date: October 27, 2021
Phase: Phase 4
Study type: Interventional

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

NCT ID: NCT04009343 Active, not recruiting - Clinical trials for Uncomplicated Falciparum Malaria

Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials

Start date: June 19, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Single-center phase II/III clinical investigation of the pharmacokinetics and pharmacodynamics of artemether-lumefantrine and dihydroartemisinin-piperaquine for gametocyte clearance and post-treatment chemoprotection in Zambian children with uncomplicated falciparum malaria.