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Plasmodium Falciparum clinical trials

View clinical trials related to Plasmodium Falciparum.

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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: NCT04788862 Completed - Malaria Clinical Trials

A Study of Blood-stage Controlled Human Plasmodium Falciparum Malaria Infection in Tanzania

Start date: July 18, 2022
Phase: N/A
Study type: Interventional

This will be a single-centre, open label trial to determine the safety and feasibility of CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to healthy Tanzanian adults with varying prior exposure to P. falciparum.

NCT ID: NCT04661579 Completed - Clinical trials for Plasmodium Falciparum

RTS,S/AS01E Hypo-immuno-responsiveness Study

Start date: November 6, 2020
Phase: Phase 2
Study type: Interventional

The proposed trial design has been developed to answer several questions related to the nature of RTS,S vaccine efficacy in African adults that may be influenced by concurrent and/or past P. falciparum infection leading to a state of immunologic hypo-responsiveness. The proposed study design encompasses five groups. Three groups (Groups 1, 2, and 3) will be administered RTS,S/AS01E on a 0, 1, 7 month schedule with Dose 3 delivered as a 1/5th fractional dose. Two groups (Groups 4 and 5) will be administered a comparator vaccine on a 0, 1, 7 month schedule.

NCT ID: NCT03452475 Completed - Clinical trials for Plasmodium Falciparum

Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children

TACTKenya
Start date: March 7, 2018
Phase: Phase 3
Study type: Interventional

This open-label randomised controlled clinical trial will compare the safety, tolerability, therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine, arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with uncomplicated falciparum malaria in Kilifi, Kenya. This study will also provide an up to date insight on the current presence of antimalarial resistance in this site. In addition, all children will be treated with a single low dose of primaquine, dosing is age based. The investigators will recruit 219 patients aged 2 years to 12 years with acute uncomplicated falciparum malaria in Kilifi County Hospital.

NCT ID: NCT03172221 Completed - Diagnoses Disease Clinical Trials

Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women

HSRDT MiP
Start date: July 25, 2017
Phase:
Study type: Observational

This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.

NCT ID: NCT03138096 Completed - Malaria,Falciparum Clinical Trials

Safety and Protective Efficacy of Pb(PfCS@UIS4)

PbVac
Start date: May 29, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that immunization of humans with P. berghei will induce a cross-species immune response without the risk of a breakthrough infection. To further increase the potential for protective efficacy, the P. falciparum circumsporozoite (CS)- protein gene has been integrated in the P. berghei parasite, generating a genetically modified P. berghei parasite, abbreviated as Pb(PfCS@UIS4).

NCT ID: NCT03132402 Completed - Clinical trials for Plasmodium Falciparum

ELISA Validation of Hypersensitive Rapid Diagnostic Test Results for Detection of P. Falciparum

ELISA
Start date: June 1, 2017
Phase:
Study type: Observational

Elimination of P. falciparum (PF) malaria across a territory requires universal access to treatment of clinical cases for communities, and specific targeting of places or population groups where malaria transmission persists in spite of generalized access to treatment. In particular, a large prevalence of carriers of PF parasites is suspected to be one of the reasons for malaria persistence. The fact that these carriers are not developing symptoms allow them to harbour and transmit parasites over long periods of time. They are likely to contribute significantly the transmission in their community and even beyond it according to their movement patterns. Identifying these pockets of high asymptomatic carriage is a key component of the malaria elimination strategy, as it allows targeting specific interventions, such as targeted mass-treatment, to quickly drain the asymptomatic reservoir. Strategically to achieve this goal we need to be able to identify quickly and reliably the villages or groups of villages in which the asymptomatic reservoir is large and should be addressed by targeted mass drug administration (MDA). There are no point of care tests currently available to detect asymptomatic carriers accurately. The available Rapid Diagnostic Tests (normal RDT) are designed to diagnose clinically relevant malaria infections. However their sensitivity for asymptomatic malaria carriers is low, since most of these individuals harbor parasitaemias below RDT detection thresholds. Currently, we are relying on high volume blood surveys, in which a small sample of the village population provides a 2mL venous blood sample that can be analysed by ultra-sensitive qPCR. This technique allows detecting very low parasitaemias. However it is a high cost test and technical requirements to use qPCR limit the number of samples that can be tested. In addition as the analysis must be done in a laboratory, the time needed for shipment and analysis results in delays of 4 to 8 weeks between survey and result. Surveying remote, poorly resourced areas adds to the challenge as the samples must be shipped from the field to the laboratory, on cold chain, within 24 to 48h from blood draw. To ensure that asymptomatic individuals are diagnosed in a cost effect and feasible manner, it is vital that a more sensitive RDT is made available for use in the field. Depending on its performance, a sensitive RDT could be used for prevalence surveys to target MDA, or directly for interventions based on treatment of positive individuals (reactive case detection or mass screening and treatment). A new hypersensitive RDT (hsRDT) has now been developed but before it can be utilised for elimination surveys we need to validate both its technical properties (sensitivity and specificity) and its usefulness in the field to detect PfHRP2 presence compared to a gold standard control ELISA (Enzyme Linked Immuno-Sorbent Assay) test. This will allow confirmation of false- and true- positive among samples.

NCT ID: NCT02895568 Completed - Clinical trials for Plasmodium Falciparum

Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

Start date: September 16, 2016
Phase:
Study type: Observational

This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.

NCT ID: NCT02692963 Completed - Malaria Clinical Trials

Safety and Protective Efficacy of BCG Vaccination Against Controlled Human Malaria Infection

BCG-EHMI
Start date: April 2016
Phase: Phase 2
Study type: Interventional

The Bacillus Calmette-Guérin (BCG) vaccine, a live attenuated Mycobacterium bovis vaccine, has been used to prevent tuberculosis for almost a century, and it is still the most used vaccine in the world. There is also circumstantial and indirect evidence that BCG vaccination can protect against malaria. Investigators hypothesize that BCG vaccination can offer protection against malaria in the Controlled Human Malaria Infection (CHMI) model. A total of 20 healthy male and female volunteers will participate in this randomized, single-blind clinical trial. Volunteers will be randomized to receive either BCG vaccination (BCG vaccine SSI) (group 1, n=10) or no treatment (group 2, n=10). Five weeks after vaccination of group 1 volunteers, all volunteers will undergo a CHMI administered by the bites of five P. falciparum infected Anopheles mosquitoes.

NCT ID: NCT02418962 Completed - Malaria Clinical Trials

Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated PfSPZ Vaccine in Equatoguinean Adults

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, placebo-controlled, double-blind trial to assess the safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI). The study to be conducted in Baney District, Bioko Island, Equatorial Guinea (EG), will be to establish whether three doses of the higher regimen - three doses of 2.7x10^5 PfSPZ of the PfSPZ Vaccine administered at 8 week intervals - is as well-tolerated and efficacious in malaria exposed African adults as the five dose regimens. Specifically, the trial will address the following objectives: is the three dose regimen: 1. Safe and well tolerated in Equatoguinean (EG) adults. 2. As immunogenic in EG adults as is the five-dose regimen of 1.35x10^5 PfSPZ in Tanzanian and U.S. adults or as three-, four- and five-dose regimens of 2.7x10^5 PfSPZ being tested in Tanzanian, Malian and U.S. adults. In addition, as an exploratory objective, the volunteers in the EG trial will be followed longitudinally to measure the incidence of malaria during the initial six months following immunization, providing a preliminary assessment of efficacy.