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Malaria, Falciparum clinical trials

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NCT ID: NCT06300970 Completed - Malaria Clinical Trials

Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia

Start date: August 9, 2022
Phase: Phase 4
Study type: Interventional

To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia.

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: 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: 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.

NCT ID: NCT05958693 Completed - Malaria,Falciparum Clinical Trials

TES of Artemether-lumefantrine for Pf in the Philippines in 2015

TES
Start date: January 5, 2015
Phase:
Study type: Observational

Artemether-lumefantrine has been used as a first-line treatment for uncomplicated Plasmodium falciparum infection since 2009 in the Philippines. The 28 day therapeutic efficacy study was conducted between February 2015 and December 2015, in accordance with WHO guidelines in the three (3) municipalities (Bataraza, Brookes and Rizal) of Palawan. Attempt was made to include Panglima-Sugala, Tawi-Tawi; however, due to the decline in the number of malaria cases, no evaluable subject was enrolled. The study subjects were febrile individuals between > 6 months old and 59 years old with confirmed uncomplicated P. falciparum. They were treated with artemether-lumefantrine (20 mg and 120 mg, respectively) administered 3 days (Days 0, 1 and 2) according to body weight. Primaquine (0.75 mg base/kg body weight single dose) was given on Day 3. Outcomes were classified as early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF) and adequate clinical and parasitological response (ACPR).

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: NCT05550909 Completed - Malaria,Falciparum Clinical Trials

Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali

NECTAR4
Start date: October 17, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine-amodiaquine (ALAQ) with and without a single dose of 0.25mg/kg primaquine (PQ). Outcome measures will include infectivity to mosquitoes at 2, 7 and 14 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.

NCT ID: NCT05507970 Completed - Malaria,Falciparum Clinical Trials

First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367

Start date: July 29, 2022
Phase: Phase 1
Study type: Interventional

This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated. In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels. In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state. In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days. Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.

NCT ID: NCT05287893 Completed - Malaria Clinical Trials

Pyronaridine in Healthy Adult Participants Infected With Blood Stage Malaria

Start date: April 4, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, adaptive study that will utilise the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile of pyronaridine. Up to 18 healthy, malaria naïve adult participants are planned to be enrolled into this study, in cohorts of up to six participants each. Following a screening period of up to 28 days, cohorts of up to 6 healthy participants will be enrolled. Each participant will be inoculated intravenously on Day 0 with P. falciparum infected erythrocytes. Participants will be followed up daily on Days 1 to 3, and will attend the clinical unit once on Days 4, 5, 6 and 7 for clinical evaluation and blood sampling. Participants will be admitted to the clinical trial unit on Day 8 for a single oral dose of pyronaridine. Different doses of pyronaridine will be administered across and within cohorts. Participants will be randomised to a dose group on the day of dosing. The highest dose of pyronaridine administered will be no more than 720 mg; the lowest dose administered will be no less than 180 mg. Each subsequent cohort will be composed of up to 3 dose groups. The Safety Data Review Team (SDRT) will review all available safety and tolerability data from the previous cohort/s prior to inoculation of the next cohort. Participants will be confined in the clinical unit for at least 96 h (Days 8 - 12) to monitor the safety and tolerability of pyronaridine dosing. Upon discharge from the clinical unit participants will be monitored on an outpatient basis up to Day 50±2. Participants will receive compulsory antimalarial rescue treatment with Riamet® (artemether/lumefantrine) on Day 47±2 or earlier.