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Malaria clinical trials

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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

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

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

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: NCT03754322 Recruiting - Malaria Clinical Trials

The Impact of Molecular Diagnosis of Malaria With LAMP in Pregnant Women

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Malaria is one of the major public health problems in sub-Saharan Africa. It contributes significantly to maternal and fetal morbidity and mortality in affected countries. The aim of this study is to evaluate the impact of enhanced case detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a prospective study design. A pilot prospective diagnostic efficacy study will be conducted from October 2018 until October 2019 in pregnant mothers at three sites in Ethiopia. Both symptomatic and asymptomatic first trimester mothers will be included in the study and individually randomized to either standard of care or one of two enhanced cased detection arms using LAMP for malaria. Mothers in the first trimester will be enrolled during a seven month period from October 2018 to October 2019 and then followed until delivery. Given the rate of pregnant mothers at the three sites, we anticipate 500 mothers in total enrolled in the study during the study period. In the first standard of care arm, venous blood sample will be collected from each study participant and the presence of Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women who test positive for malaria will be referred and treated for malaria with quinine or artemisin combination therapies (ACTs) as per national guidelines. In the second (test) arm, mothers will be tested by a commercially available CE-approved LAMP malaria test at each clinic visit in lieu of microscopy. In the third (test) arm, mothers whether symptomatic or asymptomatic will be tested by both microscopy and LAMP for malaria at each clinic visit and treated if positive by either test. Pregnant mothers who require treatment will be referred and treated with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The primary outcomes are (i) maternal anemia (ii) infant anemia at birth and (iii) fetal birth weight in each of the three arms.

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

Drug Combinations of Atovaquone-Proguanil (AP) With ACT

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: NCT03719599 Recruiting - Malaria Clinical Trials

Plasmodium and Other Parasites in Pregnant Women and Children Around Margibi and Montserrado Counties, Liberia

Start date: December 19, 2018
Study type: Observational

Background: The disease malaria affects many people in Liberia and other parts of Africa. It is caused by germs that are spread by mosquito bites. It may be mild but can be serious or can lead to death if not diagnosed and treated. Children younger than 5 years old and pregnant women are most at risk of malaria. Worms also infect many people in Liberia. They can be caused by mosquito bites or by touching soil or still water. Worm infections can be mild or serious. Doctors in Liberia and their NIH partners want to learn more about these diseases in women and children. Objective: To measure how much malaria and worm infections there are in pregnant women and children in two counties of Liberia. Eligibility: Pregnant women ages 18 and older and children ages 6 12 months seeking routine care at C.H. Rennie Hospital or the Duport Road Health Center Design: Participants will be screened with questions about their health or their child s health. Participants will be asked further questions about their health and about their home life. Participants will give a small amount of blood by finger prick. This will be tested to see if they have malaria or some types of worms, and for research studies. Participants who are sick from malaria will be treated at a study clinic. Treatment will follow standards of the Liberia and/or the World Health Organization.

NCT ID: NCT03707353 Not yet recruiting - Malaria Clinical Trials

An Efficacy Study of IV Boosting With ChAd63/MVA ME-TRAP

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

Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in African infants. Current malarial control strategies are threatened by emergence of parasite resistance to drug treatment and resistance of the mosquito vector to certain insecticides. A deployable malaria vaccine is therefore a key strategy for reducing malaria mortality and progressing towards global eradication, but those in clinical trials are currently someway short of WHO targets. ChAd63 ME-TRAP and MVA ME-TRAP are leading candidate vaccines being developed by Adrian Hill's group at the University of Oxford, and collaborators. Since 2007, testing of these vaccines intramuscularly in over 900 volunteers has shown them to be safe, well tolerated and capable of delivering partial efficacy against malaria infection. This study will be the first time studying the efficacy of giving a boosting dose of the vaccines intravenously in what the investigators call a "prime-target" strategy. It follows very encouraging pre-clinical work showing this route can target desirable immune responses to the liver to fight a crucial stage of malaria infection. An ongoing recent phase I study is dose escalating both these vaccines intravenously as a single dose prior to commencing this trial where intramuscular and intravenous doses will be combined for the first time. The investigators will initially recruit 46 healthy UK adult volunteers who will be enrolled into 4 vaccination arms (10 volunteers each) and an unvaccinated control group (6 volunteers) who will undergo a controlled human malaria infection (CHMI). These are standardised, carefully supervised infection experiments used internationally to assess vaccine efficacy. As this is the first time giving intramuscular and intravenous doses of these vaccines in a combined schedule, the investigators will closely profile the safety and immune response during the vaccination follow-up. All trial activity will take place in Oxford.

NCT ID: NCT03707041 Not yet recruiting - Malaria Clinical Trials

Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model

Start date: December 2018
Phase: Phase 1
Study type: Interventional

This is a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P. falciparum sporozoite infection model. Healthy men and women, aged 18 to 45 years will be enrolled in 3 study cohorts and will be administered either P218 or placebo twice, 48 hours apart. Subjects in cohorts 2 and 3 will be inoculated with P. falciparum sporozoites. Enrolment in cohorts will proceed sequentially, to facilitate review of data by a Safety Review Team (SRT) before proceeding with a subsequent cohort. In cohort 1, safety and tolerability of P218 will be assessed. In cohorts 2 and 3, chemoprotective activity of P218 against malaria infection will be assessed, as well as the Influence of time of initiation of the P218 treatment on the protective effect.

NCT ID: NCT03705624 Recruiting - Malaria Clinical Trials

P. Falciparum Infection Dynamics and Transmission to Inform Elimination

Start date: August 6, 2018
Phase: N/A
Study type: Interventional

In the current randomized trial, the investigators will test the ability of two experimental approaches to malaria infection management to reduce malaria transmission potential. Compounds in Saponé, Burkina Faso, will be randomized to conventional malaria control (comparator arm), enhanced community case management (CCM; experimental arm 1) or CCM supplemented with monthly screening and treatment (MSAT) regardless of symptoms followed by treatment of detected infections (CCM + MSAT; experimental arm 2). The interventions will be implemented over two transmission seasons and the dry season they enclose.

NCT ID: NCT03695770 Recruiting - Malaria Clinical Trials

Evaluation of a New Malaria Control Strategy Amongst Gold Miners Working Illegally in French Guiana (Malakit)

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

Illegal gold miners in French Guiana, a French overseas territory ('département') located in Amazonia, often carry malaria parasites (up to 46.8%). While the Guiana Shield Region aims at malaria elimination, the high prevalence of Plasmodiumin this hard-to-reach population in conjunction with frequent incorrect use of artemisinin-based anti-malarials could favor the emergence of resistant parasites. Due to geographical and regulatory issues in French Guiana, usual malaria control strategies cannot be implemented in this particular context.Therefore, new strategies targeting this specific population in the forest are required. Numerous discussions among health institutions and scientific partners from French Guiana, Brazil and Suriname have led to an innovative project based on the distribution of kits for self-diagnosis and self-treatment of Plasmodium infections. The kit-distribution will be implemented at "resting sites", which are areas across the border of French Guiana regularly frequented by gold miners. The main objective is to increase the appropriate use and complete malaria treatment after a positive malaria diagnosis with a rapid test, which will be evaluated with before-and-after cross-sectional studies. Monitoring indicators will be collected from health mediators at the time of kit distribution and during subsequent visits, and from illegal gold miners themselves, through a smartphone application. The project funding is multisource, including Ministries of Health of the three countries, WHO/PAHO, and the European Union.