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Malaria, Falciparum clinical trials

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NCT ID: NCT04251351 Recruiting - Acute Kidney Injury Clinical Trials

Effect of Paracetamol on Kidney Function in Severe Malaria

PROTECtS
Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

A randomised open labeled, parallel-group, controlled trial to assess the efficacy of paracetamol to reduce kidney dysfunction caused by cell-free haemoglobin-mediated oxidative damage in paediatric patients with falciparum malaria complicated by intravascular haemolysis.

NCT ID: NCT03947190 Recruiting - Malaria,Falciparum Clinical Trials

A Study to Determine if New Types of Malaria Vaccines Are Safe, Effective and Lead to Immunity in Kenyan Adults

Start date: August 31, 2022
Phase: Phase 2
Study type: Interventional

This is a phase IIb clinical trial in malaria-exposed individuals to assess the immunogenicity, safety and efficacy of the two vaccines in the context of controlled human malaria infection, P. falciparum sporozoite challenge (PfSPZ Challenge).

NCT ID: NCT03923725 Recruiting - Clinical trials for Plasmodium Falciparum Malaria (Uncomplicated)

A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.

DeTACT-Africa
Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.

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: NCT03511443 Recruiting - Malaria,Falciparum Clinical Trials

Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections

Start date: October 2, 2017
Phase: N/A
Study type: Interventional

A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings. A common indication is that more studies should be carried out to optimize the ACD strategy to the local context, or to provide evidence for the adoption of improved methods. One possible improved method is the use of more accurate diagnostic tools, such as the hsRDT proposed in this study, with an increased capacity to detect lower levels of parasitemia. It can provide a timely and relevant contribution for their development of national Standard Operating Procedures for a screening tool in the reactive case detection strategy.

NCT ID: NCT02604966 Recruiting - Clinical trials for Drug Resistant Malaria Due to Plasmodium Falciparum

P. Falciparum Resistance to Artemisinin in Vietnam

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

At the end of 2012, the Institute of Tropical Medicine in collaboration with National Institute of Malariology Parasitology and Entomology (NIMPE) conducted a study in Quang Nam province, central Vietnam, to assess the efficacy of the national DHA-PPQ regimen for the treatment of uncomplicated P. falciparum malaria infections, both in adults and in children. Results showed that about 30% of the study participants were parasitaemic at day 3. Parasite clearance rate was estimated at 6.2h, which was comparable to figures from Pailin, Cambodia, where artemisinin resistance were previously reported . However, results from this study have to be interpreted bearing in mind that: (i) the age-based drug dosing scheme used has been criticized as insufficient to clear parasites and (ii) DHA-PPQ drugs used (Artecan™), Vietnam, are not produced under Good Manufacturing Practices (GMPs). However, those results prompted the NMCP and WHO to declare Quang Nam, Binh Phuoc, Dak Nong, and Gia Lai provinces as a "Tier I area" (credible evidence of artemisinin resistance) in May 2013. By end of 2014 a fifth province, Khanh Hoa, was declared Tier I (Dr Hong, Personal Communication). Except for the south-eastern province of Binh Phuoc, artemisinin resistance has never been confirmed with an artemisinin based monotherapy in Central Vietnam. Therefore, in order to confirm artemisinin resistance in Central Vietnam , a study with oral artemisinin-based monotherapy, using WHO prequalified AS and DHA-PPQ and recommended dosing scheme of 4mg/kg/day for AS and DHA, is needed. In the arm where study participants are treated with 3 days of AS monotherapy, treatment will be followed by an additional 3-day course of DHA-PPQ to effectively clear all parasites. The aim of the present study is to confirm artemisinin resistance in Central Vietnam by assessing P. falciparum clearance time and rate after AS monotherapy (WHO recommended dosage). The investigators will conduct a two-arm open label, randomized study, with one arm receiving AS monotherapy for 3 days + 3-day of DHA-PPQ, and a second arm receiving 3 days of DHA-PPQ.

NCT ID: NCT01944189 Recruiting - Malaria, Falciparum Clinical Trials

Artemether/ Lumefantrine: A Study of the Effect of Local Food on Pharmacokinetics and Population Pharmacokinetics

Start date: September 2013
Phase: Phase 4
Study type: Interventional

Despite preventive programs, effective case management is still the cornerstone in malaria control. This study is as a strategy towards improved recommendations in resource limited countries during artemether -lumefantrine (AL) treatment in order to maximize the public health benefits. This is observational population pharmacokinetics study with a nested comparative bioavailability study.The study is intended to describe the variability in lumefantrine blood levels among under five year old Ugandan children with uncomplicated falciparum malaria receiving current standard artemether-lumefantrine dose regimens. Findings will form a basis for development of rational dosage recommendations. The nested comparative bioavailability study will explore effect of profiled local food intake (maize porridge plus vegetable oil versus milk) on lumefantrine uptake. As a strategy towards improved recommendations in resource limited countries during AL treatment in order to maximize the public health benefits. As a secondary objective we will correlate the variability in lumefantrine uptake to malaria treatment outcome and safety profile in this population. Research hypotheses 1. The population pharmacokinetic profile of lumefantrine among under five year old children in Uganda with uncomplicated falciparum malaria is not affected by demographic factors. 2. There is no difference in the bioavailability of lumefantrine when artemether-lumefantrine is received with maize porridge plus vegetable oil versus milk among under five year old Ugandan children treated for uncomplicated falciparum malaria.

NCT ID: NCT01713517 Recruiting - Malaria, Falciparum Clinical Trials

Impact of Insecticide Resistance on Vector Control

Start date: April 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.

NCT ID: NCT01038063 Recruiting - Malaria Clinical Trials

Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period

Start date: October 2010
Phase: Phase 4
Study type: Interventional

A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).