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Malaria clinical trials

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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.

NCT ID: NCT03689036 Recruiting - Malaria Clinical Trials

Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon: Defining a Roadmap to Malaria Elimination

Start date: April 2, 2018
Study type: Observational

A population baseline longitudinal study in a major residual malaria hotspot in Brazil to: 1. identify risk factors for residual malaria infection and disease at individual and household level, 2. identify and quantify population changes in P. vivax and P. falciparum to detect reintroductions and to estimate parasite population complexity at baseline and after interventions and 3. describe changing dynamics of malaria incidence and parasitemia prevalence over time, and to assess potential effects of combinations of interventions on malaria control and elimination using mathematical models. The study will be developed in Mâncio Lima, a residual malaria hotspot in northwestern Brazil. The population of study is approximately 2,000 subjects aged 3 months and up, who correspond to all the residents of 20% of the households of the urban area of Mâncio Lima. Will be made Active (ACD) and Passive Case Detection (PCD) every 6 months, over 5 years. (symptom based surveying; microscopy-based diagnosis). Each visit will include interview, physical examination and collection of 100 μL of blood (finger prick) to malaria diagnosis by smear, RDT and qPCR. If the subject will be positive by smear or RDT (rapid diagnostic test for malaria), despite of presence of symptoms, ≥ 20 mL of venous blood will be draw of them to immunology and parasite genetics study and the immediate treatment per MOH(Ministry of Health) guidelines will be performed. Subjects with smear or RDT negative, will be followed for symptoms over the next 6 months. If it is subsequently found to be smear/RDT-positive by PCD, the treatment will be performed. Clinical and epidemiological characteristics of malaria, genetic characteristics of the population of Plasmodium and changing dynamics of malaria transmission will be analyzed.

NCT ID: NCT03671109 Not yet recruiting - Malaria Clinical Trials

Improving Maternal heAlth by Reducing Malaria in African HIV Women

Start date: February 2019
Phase: Phase 3
Study type: Interventional

Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylacis (CTXp) and antieretoviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.

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: NCT03648411 Not yet recruiting - Clinical trials for Asymptomatic Infections

Drug Resistance Among Asymptomatic Infection

Start date: August 2018
Study type: Observational

A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar.

NCT ID: NCT03641534 Recruiting - Malaria Clinical Trials

Monitoring of Perfusion in Sepsis and Malaria

Start date: June 4, 2018
Study type: Observational

Sepsis and severe malaria together contribute to an estimated 13 million deaths annually, a great burden of which is in low-income countries. Optimal fluid management is critical yet remains one of the most challenging clinical care elements as volume overload precipitates pulmonary edema and volume restriction may exacerbate acute kidney injury. These complications of sepsis and severe malaria significantly increase mortality, particularly in resource-limited settings lacking mechanical ventilation and renal replacement therapy. Point-of-care ultrasound and passive leg raise testing are two easily implementable, safe and non-invasive clinical bedside fluid assessment tools that could be applied towards developing a fluid management algorithm in low resource settings. Similarly, simple tissue perfusion measures can facilitate understanding of precise indications or contraindication to fluid and vasopressor therapy. However, the performance of these tools has yet to be confirmed in these settings. Accurate assessment of pulmonary tolerance and fluid responsive patients could aid to tailor vasopressor and fluid therapy to the patient condition and disease phase, thus preventing or detecting iatrogenic pulmonary edema and other pulmonary complications. As there is currently limited evidence supporting fluid management recommendations for severe malaria and sepsis in low-resource settings, the potential application of these management tools could optimize supportive therapy and improve outcomes in these populations. The main activity proposed is a prospective, observational study of patients with sepsis and severe malaria to describe the relationship between fluid therapy and vasopressor therapy against measures of tissue perfusion and pulmonary congestion in adult patients with severe malaria or severe sepsis. In addition, the study will assess the performance of simple bedside clinical tools assessing fluid responsiveness, pulmonary congestion and peripheral tissue perfusion. The data from this observational study will facilitate the preparation of a follow-up study to test a clinical algorithm to guide individualized fluid and vasopressor administration.

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

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.