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Malaria clinical trials

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NCT ID: NCT05874271 Recruiting - Vivax Malaria Clinical Trials

Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea

SCOPE
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax. P. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allows it to escape detection and treatment. Importantly, they are susceptible only to 8 aminoquinolines such as primaquine. However, primaquine is associated with risk of haemolysis in individuals with a genetic condition, called glucose-6-phosphate dehydrogenase (G6PD) deficiency. Additionally, the recommended 14-day prolonged treatment regimen is associated with poor treatment adherence, hence ineffective primaquine treatment. Innovative solutions to the radical cure of both the blood and liver stages of P. vivax are urgently required. The PNG National Department of Health has requested a pragmatic study of the feasibility and cost-effectiveness of implementing point-of-care G6PD testing followed by high-dose, short-course primaquine treatment regimens for patients with P. vivax malaria. This revised case management is to be combined with practicable enhancements to patient education, supervision, malariometric surveillance and pharmacovigilance. This will be a before-after longitudinal health facility-based study implemented at Napapar and Mugil health centres and Baro and Wirui clinics. A staged approach for the implementation of the revised case management strategy will be used, including patient education and counselling, community-based clinical review, with mixed methods evaluation.

NCT ID: NCT05856357 Recruiting - Anemia Clinical Trials

Perennial Malaria Chemoprevention (PMC) in Côte d'Ivoire

Start date: August 11, 2023
Phase:
Study type: Observational

The Plus Project will assess the impact, operational feasibility, efficacy, effectiveness, and cost-effectiveness of PMC. Specifically, the impact evaluation will involve monitoring a passive cohort of all children in the study area reporting all doses of SP received and the number of confirmed cases of malaria and anaemia, as well as a prospective active cohort of children who will have seven home visits over an 18-month period. The total number of participants is expected to be approximately 1568 children in the areas served by 19 health centres in Côte d'Ivoire. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.

NCT ID: NCT05842954 Recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum Malaria

KALUMA
Start date: March 7, 2024
Phase: Phase 3
Study type: Interventional

This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.

NCT ID: NCT05829187 Completed - Clinical trials for Uncomplicated Plasmodium Falciparum

Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency

MCHUPF
Start date: November 1, 2022
Phase: Phase 2
Study type: Interventional

Currently, the first-line combination of artemisinin, piperaquine and prima-quine is quite effective in controlling malaria, however, the threat of spread of drug-resistant parasites has been reported. A study is conducted to assess the efficacy and safety extract of bitter melon (Momordica charantia/MC) regimens compared to the combination of dihydroartemisinin piperaquine primaquine (DHP+PQ) on the sexual and asexual stage of P. Falciparum uncomplicated in Sumba Barat Daya District, Indonesia

NCT ID: NCT05816330 Completed - Malaria Clinical Trials

L9LS MAb in Malian Adults

Start date: May 25, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.

NCT ID: NCT05801198 Not yet recruiting - Malaria,Falciparum Clinical Trials

Addressing Asymptomatic Plasmodium Reservoirs to Accelerate Malaria Elimination and Eradication in Rwanda.

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

The investigators believe that to effectively achieve malaria elimination in Rwanda, it is critical to target the human reservoirs of Plasmodium falciparum using local and readily available Artemisia tea. Asymptomatic infections detectable by PCR are important reservoirs because they often persist for months and harbor gametocytes, the parasite stage infectious to mosquitoes. Lessons learnt from this study will be of critical importance for health decision makers with regard to potential malaria control. MSc and PhD students will be trained and the impact of this research project will be enormous on the socioeconomic transformation of Rwanda.

NCT ID: NCT05796193 Not yet recruiting - Malaria Clinical Trials

Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote d'Ivoire

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

The investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte d'Ivoire. The primary objective of the project is to evaluate the efficacy of chlorfenapyr-pyrethroid and piperonyl-butoxide (PBO) synergist-pyrethroid LLINs on malaria case incidence in children aged 6 months to 10 years compared to standard pyrethroid-only LLINs. The secondary objectives are to evaluate the efficacy of the two intervention LLINs compared to the standard LLIN on a) malaria infection prevalence in the general population (both children and adults), b) vector density and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, changes in phenotypic resistance intensity and selection for molecular resistance mechanisms at baseline and 12 months post-LLIN distribution, in sentinel villages in each treatment arm will be investigate. It is vital to demonstrate that these next generation LLINs which are becoming the standard of care in Sub Saharan AFRICA, are superior to standard py-LLIN in the most extreme resistance areas as this is likely where alternative interventions will be most needed to keep malaria control on track. The trial will generate the first epidemiological evidence on the efficacy of PBO nets compared to py-LLIN in West Africa.

NCT ID: NCT05790889 Recruiting - Malaria,Falciparum Clinical Trials

A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.

Start date: April 3, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso

NCT ID: NCT05788094 Recruiting - Malaria Clinical Trials

ACT vs CQ With Tafenoquine for P. Vivax Mono-infection

ACTQ
Start date: June 26, 2023
Phase: Phase 4
Study type: Interventional

In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020 ASTMH Annual Meeting) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019 NEJM; Watson et al. 2022a Elife). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.

NCT ID: NCT05776017 Recruiting - Malaria,Falciparum Clinical Trials

MSP3-CRM-Vac4All/ Alhydrogel® Vaccine

Start date: March 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Two-arm, randomized, double-blinded and controlled clinical trial to first assess the safety and tolerability of the vaccine in a Phase 1b trial and proceed to assess its efficacy against clinical malaria in young children living in highly seasonal malaria areas of Mali