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Malaria clinical trials

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NCT ID: NCT01624337 Terminated - Malaria Clinical Trials

Malaria Prevention Cambodia

MPC
Start date: May 2012
Phase: N/A
Study type: Interventional

Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.

NCT ID: NCT01615822 Terminated - Malaria Clinical Trials

Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers

Start date: August 2012
Phase: Phase 1
Study type: Interventional

OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.

NCT ID: NCT01445938 Terminated - Malaria Clinical Trials

Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Start date: October 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria Secondary Objectives: - To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs) - To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A

NCT ID: NCT01442168 Terminated - Malaria, Falciparum Clinical Trials

Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

Start date: September 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation. The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).

NCT ID: NCT01290601 Terminated - Malaria Clinical Trials

Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults

Start date: September 15, 2003
Phase: Phase 2
Study type: Interventional

This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3 days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse (hypnozoite eradication). It will also further establish the safety and tolerability of these doses of tafenoquine.

NCT ID: NCT01107145 Terminated - Clinical trials for Plasmodium Vivax Malaria

Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)

PAACT-PV
Start date: February 2011
Phase: Phase 4
Study type: Interventional

The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent relapse. As primaquine can not be used in pregnant women, these women remain at risk of relapse. As there is increasing concern about chloroquine resistant P. vivax in this region, there is a need to identify alternative treatment options. The artemisinin combination therapies are recommended for use against P. falciparum infections in pregnant women after the 1st trimester; additional data are needed to support the use of these drugs against P. vivax.

NCT ID: NCT01082731 Terminated - Malaria Clinical Trials

Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil

PAACT-PF
Start date: November 2010
Phase: Phase 4
Study type: Interventional

Data on the burden of MIP in low transmission areas, such as Latin America, are very limited; there is even less information on the efficacy of case management of MiP. The treatment recommendations for MiP in Latin American countries have been changing rapidly in recent months; currently, either artemether-lumefantrine (AL) or mefloquine-artesunate (MA) is the first line treatment for P. falciparum (depending on country); however, no data exists on the efficacy of these drugs for the treatment of malaria in pregnancy in Latin America to support their use. We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety and efficacy of the present therapies, AL and MA. We hypothesize that the drugs will both be efficacious for use in pregnant women in Brazil.

NCT ID: NCT01024686 Terminated - Malaria Clinical Trials

Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine

Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess safety and tolerability of escalating doses of a genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy malaria-naive adults. The study will also assess preliminary efficacy of p52-/p36- GAP vaccine following primary experimental challenge with P. falciparum sporozoites. Lastly, the study will assess immunogenicity of p52-/p36- GAP in malaria-naïve healthy adults and preliminary efficacy of p52-/p36- GAP vaccine following primary experimental re-challenge with P. falciparum sporozoites.

NCT ID: NCT00988507 Terminated - Clinical trials for Plasmodium Falciparum Infection

Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

FARM
Start date: October 2009
Phase: Phase 2
Study type: Interventional

Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment. Secondary objectives: - To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment. - To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone. - To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.

NCT ID: NCT00964691 Terminated - Malaria Clinical Trials

A Randomized Controlled Trial for Intermittent Preventive Treatment in Pregnancy With Fansidar in Solomon Islands

IPTpRCT
Start date: August 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effectiveness of intermittent preventive treatment in pregnancy (IPTp) with Sulphadoxine-pyrimethamine compared to chloroquine prophylaxis in Honiara, Solomon Islands for prevention of malaria and it's adverse effects in pregnancy.