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Malaria, Falciparum clinical trials

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NCT ID: NCT02329301 Completed - Malaria Clinical Trials

Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia

Start date: September 2014
Phase: N/A
Study type: Interventional

To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD malaria case incidence and cohort infection incidence in areas of high and low malaria transmission and in a program-relevant manner that will permit adoption and adaptation for wider-scale deployment.

NCT ID: NCT02325180 Completed - Malaria, Falciparum Clinical Trials

Artemisinin-based Combination Therapy for Treatment of Plasmodium Falciparum Malaria in North Sumatera, Indonesia

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This is a prospective, open label, randomised controlled trial to assess the safety and efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria infection. Molecular markers for antimalarial resistance will also be assessed and the presence of molecular markers in the parasites will be associated with treatment outcomes.

NCT ID: NCT02252640 Completed - Clinical trials for Plasmodium Falciparum Malaria

A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess two types of new malaria vaccines in different combinations. The study will enable us to assess: 1. The ability of the vaccines to prevent malaria infection. 2. The safety of the vaccines in healthy participants. 3. The response of the human immune system to the vaccines. We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under carefully regulated conditions. We will follow participants closely to observe if and when they develop malaria. If the vaccine combination provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. We will also recruit 4 individuals to be control subjects - these participants won't receive any vaccinations but will be challenged with malaria. Vaccinated volunteers who do not develop malaria infection in the blood after being infected with malaria by mosquito bite the first time may be invited back to be again infected with malaria in a repeat challenge experiment. This would happen approximately 5-7 months after the first challenge. The purpose of this second challenge will be to see how long the protection of the investigational vaccine against malaria lasts.

NCT ID: NCT02237586 Completed - Malaria Clinical Trials

Effect of Plasmodium Falciparum Exposure and Sickle Cell Trait on Infection Rates and Kinetics After IV Administration of PfSPZ Challenge

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) administration in three groups with different malaria immunity-status: 1. Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA) 2. Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS) 3. Adults without previous malaria episodes without sickle cell trait (HbAA) Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear positivity after challenge will be assessed. If in any of the groups with a history of lifelong malaria exposure, 50% or less of individuals become thick blood smear positive during the 28 days post injection of PfSPZ Challenge, the dose will be increased 4-fold to 12,800 PfSPZ in this group.

NCT ID: NCT02181088 Completed - Malaria Clinical Trials

A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.

NCT ID: NCT02132299 Completed - Malaria Clinical Trials

Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults

Start date: April 2014
Phase: Phase 1
Study type: Interventional

This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ Vaccine) administered intravenously (IV).

NCT ID: NCT02123290 Completed - Clinical trials for Plasmodium Falciparum Malaria

DSM265 Phase IIa Investigation Treating Plasmodium Falciparum or Vivax

Start date: January 2016
Phase: Phase 2
Study type: Interventional

This will be a Proof-of-concept / Phase IIa, open label study to examine the efficacy of DSM265 in uncomplicated Plasmodium vivax and Plasmodium falciparum blood-stage malaria in adult patients. A minimum of two cohorts (20 patients) and a maximum of 6 cohorts (60 patients, 3 dose levels) will be tested. The starting dose of DSM265 for the first P. vivax and P. falciparum cohorts will be 400 mg. This dose is expected to show complete clearance of parasites by microscopy by Day 7 and a decrease in recrudescence rate assessed at Day 14 (success criteria for dose de-escalation and continuation of the study).

NCT ID: NCT02115516 Completed - Malaria Clinical Trials

Safety and Protective Efficacy of Intravenous Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chemoprophylaxis

Start date: April 2014
Phase: Phase 1
Study type: Interventional

TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled human malaria infection (CHMI).

NCT ID: NCT02089841 Completed - Clinical trials for Plasmodium Falciparum Malaria

Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.

ALE
Start date: May 2012
Phase: Phase 4
Study type: Interventional

Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.

NCT ID: NCT02084602 Completed - Malaria, Falciparum Clinical Trials

Assessment of Artesunate/Mefloquine in the Peruvian Amazon

Artesunate
Start date: June 18, 2014
Phase: Phase 4
Study type: Interventional

There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border. The purpose of this research study, is to assess the in vitro and in vivo efficacy of combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia and other important outcomes.