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Malaria, Falciparum clinical trials

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NCT ID: NCT03814616 Recruiting - Malaria,Falciparum Clinical Trials

Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections

Start date: October 3, 2018
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy of Pyramax administered for three-day, two-day or one day, in clearing a P. falciparum infection in asymptomatic carriers.

NCT ID: NCT03813108 Recruiting - Malaria,Falciparum Clinical Trials

Safety and Efficacy of NF135 CPS Immunization

CPS135
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This is an open label, randomized, controlled clinical trial. The primary aim of this project is to determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxis against homologous and heterologous challenge infection.

NCT ID: NCT03806465 Not yet recruiting - Mortality Clinical Trials

Malaria Vaccine Evaluation Programme

MVPE
Start date: January 2019
Phase:
Study type: Observational

This is an evaluation of feasibility, safety and impact of the RTS,S/AS01 vaccine introduction, implemented in a pilot programme by Ministries of Health using an expanded schedule of their routine EPI contacts in moderate to high malaria transmission settings in Ghana, Kenya and Malawi. The Ministries of Health in Ghana, Kenya and Malawi plan to introduce the malaria vaccine, sub nationally. This provides an opportunity in each country to evaluate the following : 1. To evaluate the programmatic feasibility to deliver a 4 dose schedule; 2. To collect information on a larger scale on the safety of the malaria vaccine with focus on cerebral malaria and meningitis; 3. To evaluate the impact of the malaria vaccine on all cause mortality.

NCT ID: NCT03783299 Enrolling by invitation - 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: NCT03726593 Recruiting - Clinical trials for Plasmodium Falciparum Malaria (Drug Resistant)

Drug Combinations of Atovaquone-Proguanil (AP) With ACT

APACT
Start date: October 4, 2018
Phase: Phase 4
Study type: Interventional

Investigators are conducting this study due to recent reports of many of existing malaria drugs becoming less effective for treatment of malaria. The drugs may not always kill all the parasites, therefore not all patients with malaria are being cured. The main objective of the study is to find out which malaria drugs and what drug combinations are still effective in Cambodia, an area of multi-drug resistance where 4-5 artemisinin-based combination therapies have shown inadequate response, below that established by the World Health Organization (WHO). New drug combinations (taking more than one drug for malaria at the same time), as long as well tolerated, can provide cure in patients that harbor parasites not responsive to standard first-line medications. Human genetic testing will be done to identify patients who may have suboptimal response to treatments and to study the differences in human gene expression to explain why some persons are at higher risk of complications during treatment. Markers of drug resistance to commonly used antimalarial drugs will also be evaluated and shared with national malaria program (CNM) to better guide future malaria treatment decisions in Cambodia.

NCT ID: NCT03697668 Recruiting - Clinical trials for Plasmodium Falciparum Malaria (Drug Resistant)

Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites

Artesynib
Start date: September 17, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide a new drug combination for a better treatment of P. falciparum for a faster parasite clearance and to counteract artemisinin resistance.

NCT ID: NCT03660839 Recruiting - 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 5, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To show the contribution of OZ439 to the clinical and parasiticidal effect of OZ439/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 AUC of OZ439 as PK predictor. Secondary Objective(s): - To evaluate the dose response of OZ439 combined with FQ on PCR-corrected ACPR and crude Day 28 ACPR, and on other 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.