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Malaria 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: NCT06257810 Completed - Malaria Clinical Trials

Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the inappropriate use of antibiotics (discontinuation or non-initiation) and optimize the clinical management and prognosis of patients.

NCT ID: NCT06225700 Completed - Malaria Clinical Trials

Clinical Validation of Novel Malaria Diagnostic Tools for POC Point-of-Care Testing

Start date: March 1, 2023
Phase:
Study type: Observational

The aim of this study is to perform a performance evaluation of novel diagnostic tools for detecting malaria in malaria-endemic countries. At the beginning of 2022, FIND launched a call for innovation with the distinct aim to identify malaria innovations that have the potential to address the technical and operational limitations of current malaria RDTs, particularly in view of the emergence of P. falciparum parasites with hrp2/3 deletions, the need for improved tools to identify all Plasmodium species and/or the need for improved surveillance. This study will generate valuable data on the performance of these novel non-HRP2-based tests and inform FIND and developers on technical and operational assay optimization requirements for accelerated access of these tools to market.

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: 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: NCT05958797 Completed - Malaria Clinical Trials

TES of Chloroquine for Pv in the Philippines in 2016

TES
Start date: January 4, 2016
Phase:
Study type: Observational

Chloroquine (CQ) is officially used as a first-line drug of Plasmodium vivax malaria in the Philippines. In this study, the therapeutic efficacy of CQ for the treatment of uncomplicated P. vivax malaria in three (3) municipalities (Bataraza, Brooke's Point and Rizal) of Palawan was evaluated using the World Health Organization protocol with a follow-up of 28 days and additional 2 days (Day 31 and 34) for hemoglobin monitoring after primaquine treatment. Study subjects were febrile individuals between > 6 months old and 59 years old with confirmed uncomplicated P. vivax infections. Chloroquine was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2), and primaquine following the National Treatment Guidelines. During the 1 year period that this report covers, there were 8,305 individuals were screened.

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).