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Malaria clinical trials

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NCT ID: NCT06064591 Recruiting - Severe Malaria Clinical Trials

Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX

IMMETASEX
Start date: December 13, 2023
Phase:
Study type: Observational [Patient Registry]

Understanding the sexual conversion of the malaria parasite is essential to interrupt malaria transmission. A new tool is developed that, based on expression analysis of sexual stage biomarkers, will estimate sexual conversion rates in natural infections.

NCT ID: NCT06044805 Completed - Malaria Clinical Trials

Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax

CQ+PQ
Start date: December 19, 2022
Phase: Phase 4
Study type: Interventional

The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia. The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter. Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria. This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.

NCT ID: NCT06040346 Not yet recruiting - Malaria Clinical Trials

Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed With Plasmodium Falciparum

Start date: March 15, 2024
Phase: Phase 2
Study type: Interventional

This phase 2a open-label study to assess Meplazumab in adult patients diagnosed with Plasmodium falciparum

NCT ID: NCT06036030 Completed - Malaria Clinical Trials

Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua

MCMPFPB
Start date: January 11, 2019
Phase: Phase 2
Study type: Interventional

Comparing the efficacy of the combination treatment of bitter melon fruit extract (Momordica charantia) with primaquine (MC+PQ) against the combination of dihydroartemisinin + piperaquine + primaquine (DHP+PQ) on patients with Plasmodium falciparum and Plasmodium vivax without complications in Manokwari, West Papua, Indonesia. The research was conducted from January 2019 to April 2019 at Manokwari Regional General Hospital, West Papua. Open label, 2 parallel randomized clinical studies with Plasmodium falciparum malaria patients without complications (Study 1) and patients with Plasmodium vivax malaria without complications (Study 2). The randomized clinical trial divided in 2 treatment groups, namely the MC+PQ and DHP+PQ. The Success of the treatment was determined by the combination of blood schizontocidal therapy in radical cure. The overall final assessed results were the average value of parasitological failure, hematological measurements, liver function, kidney function, blood lipid levels, blood glucose levels and adverse events until day 42.

NCT ID: NCT05980156 Completed - Malaria,Falciparum Clinical Trials

Comparing Chemoprevention Drugs for School-based Malaria Control

Start date: February 13, 2023
Phase: Phase 4
Study type: Interventional

This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence in young children sleeping student's households to assess the impact on transmission.

NCT ID: NCT05979896 Recruiting - Malaria Clinical Trials

Chemoprevention Efficacy Study Nigeria

Start date: July 28, 2023
Phase: Phase 4
Study type: Interventional

The study aims to assess the chemoprevention efficacy of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) used in standard age-based dosing regimens used in Seasonal Malaria Chemoprevention (SMC) and SPAQ resistance marker prevalences and assocations among children 3 - 59 months in Sokoto and Kwara States, Nigeria.

NCT ID: NCT05979207 Completed - Inflammation Clinical Trials

Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP). Up to 18 participants will be enrolled in cohorts of up to 6 participants each. The study will proceed as follows for all participants: - Screening period of up to 28 days to recruit healthy adult participants. - Day 0: Intravenous inoculation with approximately 2,800 viable P. falciparum-infected red blood cells. - Days 1-3: Daily follow up via phone call or text message. - Days 4-7: Daily site visits for clinical evaluation and blood sampling to monitor malaria parasite numbers via quantitative polymerase chain reaction (qPCR). - Day 7 PM: Start of confinement within the clinical trial unit. - Day 8: Administration of a single oral dose of the IMP (MMV367). Different doses of MMV367 will be administered across and within cohorts in order to effectively characterise the PK/PD relationship. - Days 8-11: Regular clinical evaluation and blood sampling while confined to monitor malaria parasite numbers and measure MMV367 plasma concentration. - Day 11 AM: End of confinement within clinical trial unit. - Days 12-23: Outpatient follow-up for clinical evaluation and blood sampling. - Day 24: Initiation of compulsory definitive antimalarial treatment with Riamet® (artemether/lumefantrine) and/or other registered antimalarials if required. Treatment will be initiated earlier than Day 24 in the event of: - Insufficient parasite clearance following IMP dosing - Parasite regrowth following IMP dosing Characterising the pharmacokinetic/pharmacodynamic relationship of MMV367 - Participant discontinuation/withdrawal, - Investigator's discretion in the interest of participant safety. - Day 27: End of study visit for final clinical evaluation and to ensure complete clearance of malaria parasites.

NCT ID: NCT05978037 Recruiting - Malaria Clinical Trials

A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines

Start date: August 18, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. There is a great need for a safe, effective malaria vaccine and the team at University of Oxford is trying to make vaccine(s) which can prevent serious illness and death. This study is being done to assess an experimental malaria vaccine for its ability to prevent malaria illness. This is done using a 'blood-stage challenge model'. This is when volunteers are infected with malaria parasites using malaria-infected red blood cells. The vaccine we are testing in this part of the study is called "RH5.2-VLP". It is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination. RH5.2-VLP is being tested for the first time in humans in this trial. The Matrix-M adjuvant has been given to tens of thousands of people, with no major concerns, such as illness. The aim is to use this vaccine and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess: 1. The safety of the vaccine in healthy participants. 2. The response of the human immune system to the vaccine. 3. The ability of the vaccine to prevent malaria illness (Group 2 only). We will do this by giving healthy adult participants (aged 18-45) three of the vaccines and/or expose participants to malaria infection at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital in Oxford. We will then do blood tests and collect information about any symptoms that occur after vaccination. There will be 19 to 54 visits, lasting between 3 months to 2 years and 2 months.

NCT ID: NCT05974267 Recruiting - Malaria Infection Clinical Trials

Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)

Start date: November 28, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.

NCT ID: NCT05958810 Completed - Malaria,Falciparum Clinical Trials

TES of Artemether-lumefantrine for Pf in the Philippines in 2017-2018

TES
Start date: January 2, 2017
Phase:
Study type: Observational

The emergence and spread of drug resistance is a major obstacle to combating malaria. The World Health Organization (WHO) recommends that regular efficacy monitoring should be undertaken by all malaria endemic countries that have deployed artemisinin combination therapy (ACT), to help early detection of drug resistant strains of the parasite and contain their rapid spread. Artemether-lumefantrine (AL) has been the first-line antimalarial drug against uncomplicated Plasmodium falciparum malaria in the Philippines since 2009, with primaquine as an anti-relapse drug. The objective of this study is to assess the safety and efficacy of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in the Philippines. The study was conducted in three (3) municipalities (Bataraza, Brooke's Point, and Rizal) of Palawan. Single-arm prospective study of a 28-day follow-up was conducted from February 2017 to December 2018 according to the revised WHO 2014 drug efficacy study protocol. Study subjects were consenting individuals seeking care at the selected Rural Health Units, who were aged >6 months old to 59 years old with confirmed uncomplicated P. falciparum infections. AL was administered for 3 days according to body weight (Days 0, 1 and 2) and primaquine 0.75 mg/kg body weight single dose was given on Day 3 following the National Treatment Guidelines.