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Malaria, Falciparum clinical trials

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NCT ID: NCT03896724 Completed - Malaria,Falciparum Clinical Trials

Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso

Start date: May 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a double blind randomised controlled clinical trial to evaluate the efficacy of R21 adjuvanted with Matrix-M in healthy 5-17 month old children in a malaria endemic area.

NCT ID: NCT03882528 Completed - Malaria,Falciparum Clinical Trials

Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54

Start date: March 4, 2019
Phase: Phase 1
Study type: Interventional

Objectives: Primary: • To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data) Secondary: - To assess safety of the new lot of P falciparum parasites - To assess the kinetics of detecting parasitemia and parasite clearance by quantitative polymerase chain reaction (qPCR) as compared to blood smear - To obtain plasma samples to restore the testing control pool for malaria serology testing and for future malaria research

NCT ID: NCT03867331 Completed - Malaria,Falciparum Clinical Trials

To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers

Start date: March 13, 2019
Phase: Phase 1
Study type: Interventional

This study is a proof-of-concept, first in human, Phase I, single center study designed to evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in healthy, malaria-naïve adult volunteers. The VLPM01 product will be adjuvanted with alhydrogel. The study design was based on the FDA's guidance "General Principles for the Development of Vaccines to protect Against Global Infectious Diseases" (2011).

NCT ID: NCT03783299 Completed - Clinical trials for Plasmodium Falciparum Malaria

Targeted Active Case Detection Among High Risk Populations in Southern Lao Peoples Democratic Republic

Start date: November 28, 2017
Phase: Phase 4
Study type: Interventional

This study assesses the effectiveness of targeted active case detection among high-risk populations in Southern Lao Peoples Democratic Republic (PDR). The investigators hypothesize that active case detection using the next generation of HRP-2 rapid diagnostic tests (RDTs) can help bridge gaps in identification of high-risk asymptomatic individuals with low density parasitemia, allowing for targeting of this reservoir and thereby reducing transmission. The investigators hypothesize that active case detection (testing and treating positive cases) with these RDTs will lead to a reduction in P. falciparum transmission.

NCT ID: NCT03773536 Completed - Clinical trials for Plasmodium Falciparum Malaria

Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar

AcoV
Start date: May 9, 2017
Phase: Phase 4
Study type: Interventional

The general objective of this study is to assess the therapeutic efficacy and safety of artesunate + amodiaquine combined with a single low dose of primaquine (0.25 mg/kg) for the treatment of uncomplicated P. falciparum malaria patients in Zanzibar. The specific objectives are: - To determine the clinical and parasitological efficacy of artesunate + amodiaquine and primaquine in the treatment of uncomplicated Plasmodium falciparum infection. - To differentiate recurrent infections during follow-up, i.e. recrudescence from new infections, by polymerase chain reaction (PCR). - To evaluate the incidence of adverse events, particularly with regards to potential hematological adverse events of primaquine. - To determine the polymorphism of molecular markers associated with artesunate + amodiaquine tolerance/resistance. - To formulate recommendations, which will enable the Zanzibar Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated or not. - To determine efficacy rate of the first line treatment compared to the first efficacy trial thirteen years ago.

NCT ID: NCT03768908 Completed - Clinical trials for Plasmodium Falciparum Malaria

Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005

ACOII
Start date: January 5, 2005
Phase: Phase 4
Study type: Interventional

The primary objective of the study was to determine the PCR-APCR up to day 42 in children <60 months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+ amodiaquine (ASAQ) or artemether-lumefantrine (AL; Coartem®). Secondary objectives included: clinical and laboratory assessment of drug tolerability and safety, evaluation of possible correlation between drug bioavailability and clinical outcome, comparison of efficacy data with the pre-implementation "ACO I" study, parasite and fever clearance, gametocyte carriage, and possible selection of mutations related to quinoline resistance.

NCT ID: NCT03764527 Completed - Clinical trials for Plasmodium Falciparum Malaria

Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar

AcoI
Start date: November 1, 2002
Phase: Phase 4
Study type: Interventional

The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®. Secondary objectives were to determine safety and possible selection of mutations related to the resistance of the tested drugs.

NCT ID: NCT03660839 Completed - Clinical trials for Plasmodium Falciparum Infection

Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria

Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and the area under the curve (AUC) of OZ439 as pharmacokinetic (PK) predictor. Secondary Objectives: - To evaluate the exposure-response of OZ439 combined with FQ on crude Day 28 ACPR. - To evaluate the dose response of OZ439 combined with FQ on PCR-corrected and crude Day 28 ACPR. - To evaluate the dose-response of OZ439 combined with FQ on selected secondary endpoints. - To evaluate the safety and tolerability of different dosages of OZ439 in combination with FQ and FQ alone. - To characterize the PK of OZ439 in plasma, and of FQ and its active metabolite SSR97213 in blood.

NCT ID: NCT03580824 Completed - Malaria,Falciparum Clinical Trials

A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants

Start date: April 30, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.

NCT ID: NCT03454048 Completed - Malaria,Falciparum Clinical Trials

Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2

CHMI-trans2
Start date: May 7, 2018
Phase: N/A
Study type: Interventional

This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf) gametocyte carriers for Anopheles mosquitoes.