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Malaria, Falciparum clinical trials

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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.

NCT ID: NCT03640403 Not yet recruiting - Anemia Clinical Trials

Intermittent Preventive Treatment to Shrink the Malaria Reservoir and relaTed Morbidities by Targeting School Children in Regions With Different Malaria Endemicities

InSMART-school
Start date: January 2019
Phase: Phase 4
Study type: Interventional

Background: In endemic settings, among school aged children, malaria accounts for about 13-50% of all school absenteeism, causes anaemia and around 50% of the mortality and impairs the educational achievement of children. Intermittent preventive treatment (IPT) of pregnant women as well as seasonal malaria chemoprevention in children under the age of five have been implemented in several sub-Saharan countries and have proven to be very effective. However, none of these IPT strategies is targeting school children. A clinical trial is being conducted to expand the IPT by testing effectiveness and safety of two antimalarial drugs Sulfadoxine-Pyrimethamine (SP) combined with either Amodiaquine (AQ) or Piperaquine (PPQ) in preventing malaria related morbidity in school aged children (IPTsc). Methods: A superiority, randomized, open label, controlled trial will enrol 3180 school children aged 5-15 years, who will receive either SP+AQ or SP+PPQ or control (no drug ), using a "balanced block design" with the "standard of care" arm as reference. The interventional treatments are given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. All study-arms receive bed nets, early diagnosis and care for malaria, and praziquantel and albendazole as mass treatment for helminthiasis. The primary endpoint are change in mean haemoglobin concentration at months 4,8,16, 12 and 20 of follow-up, and prevalence of malaria asymptomatic infections at month 0, 12 and 20. Adverse events will be monitored throughout the study. Mixed design methods will be used to assess the acceptability, cost-effectiveness and feasibility of this IPTsc as part of a more comprehensive school children health package. Discussion: The national school health programme (NSHP), Tanzania, combines schistosomiasis and soil transmitted helminthes (STH) control package under national schistosomiasis and STH control programme (NSSCP). Malaria intervention using IPTsc strategy may be integrated in NSHP with the same platform as NSSCP, however, there is limited systematic evidence to assess the operational feasibility of this approach. School aged children are a reachable target population in any endemic malaria setting. The suggested strategy will provide effective protection against malaria, hasten either the elimination process and/or diminish the reservoir and burden.

NCT ID: NCT03580824 Not yet recruiting - Malaria,Falciparum Clinical Trials

A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants

Start date: November 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.

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: NCT03462615 Not yet recruiting - Clinical trials for Plasmodium Falciparum Malaria

Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women in Papua New Guinea

Start date: April 2018
Phase: N/A
Study type: Observational

Malaria during pregnancy remains an important public health issue in endemic countries. Most cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes, such as maternal and neonatal anaemia as well as low birth weight. Infections that do not cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth restriction, premature birth, miscarriage and stillbirth. The Bill & Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a promising diagnostic and screening test for subclinical malaria during pregnancy. The overall aim is to compare the performance of novel high sensitivity rapid detection tests with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in pregnant women in Papua New Guinea

NCT ID: NCT03454048 Recruiting - Malaria,Falciparum Clinical Trials

Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2

CHMI-trans2
Start date: May 7, 2018
Phase: N/A
Study type: Interventional

This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf) gametocyte carriers for Anopheles mosquitoes.

NCT ID: NCT03453840 Recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

EXALT
Start date: February 19, 2018
Phase: Phase 4
Study type: Interventional

This project will determine the pharmacokinetic/pharmacodynamic (PK/PD) of an extended artemether-lumefantrine (AL) dosing regimen in HIV-infected children on efavirenz (EFV)-based antiretroviral therapy (ART) that is designed to improve the PK exposure and treatment efficacy of this artemisinins-based combination therapy (ACT) regimen. Our overarching goal is to inform the best treatment guidelines for young children in Africa. HIV-infected and HIV-uninfected children will be enrolled for intensive PK studies, as well as additional children for population PK studies to enhance association analyses with clinical outcomes.

NCT ID: NCT03435874 Recruiting - Malaria,Falciparum Clinical Trials

Safety and Immunogenicity of ChAd63 RH5 and MVA RH5 in Adults, Young Children and Infants Living in Tanzania

Start date: April 12, 2018
Phase: Phase 1
Study type: Interventional

This is a dose-escalation, age de-escalation randomised double-blind controlled Phase Ib trial to assess the safety, tolerability and immunogenicity of ChAd63-RH5 administered with MVA-RH5 in a heterologous prime-boost regimen. Adults (18-35 years), young children (1-6 years) and infants (6-11 months) will be enrolled in the study. Safety data will be collected for each of the vaccination regimens. The humoral and cellular immune responses generated by each of these regimens will be assessed.

NCT ID: NCT03431714 Completed - Clinical trials for Uncomplicated Falciparum Malaria

Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania

GF-TES-2017
Start date: July 14, 2017
Phase: Phase 4
Study type: Interventional

The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of different antimalarials in the country. Most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data on the performance of other artemisinin based combination therapy (ACTs) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. This study was undertaken in the same NMCP framework to assess the efficacy and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP sentinel sites of Kibaha and Ujiji from July to December 2017.