View clinical trials related to Malaria.
Filter by:This is a prospective, open-label, multicenter, non-comparative, single arm study of pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of age. A total of 60 subjects will be enrolled. Potential subjects who are slide-positive for P. vivax will be started by the site on chloroquine (CQ) per local/national guidelines. Sites will have up to 48 hours to obtain consent. Once full consent is provided, all subjects will be screened and, if eligible, receive Tafenoquine (TQ), given as a single dose on Day 1. All study medication should be taken with food. After the treatment period, subjects will attend up to 7 follow-up visits through Day 120 (Days 3, 8, 15, 29, 60, 90 and 120). The main cohort will consist of subjects aged >=2 years to <16 years with no restriction on gender. Subjects will be dosed according to four weight bands. Within the total of 60 enrolled pediatric subjects, a second cohort of up to 6 infants aged >=6 months to <2 years (weighing >=5 kilogram [kg]) will be recruited following completion of a planned first interim analysis. An interim analysis will be conducted once sufficient data from 16 subjects is available to assess pharmacokinetic (PK) and safety parameters. If needed, a second interim analysis will be conducted after a total of 32 subjects have enrolled. The primary objective of this PK bridging study is to adequately characterize the systemic TQ exposure in the pediatric population in order to identify appropriate doses that achieve a similar exposure to that of the TQ adult dose of 300 milligram (mg).
The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years. The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).
The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to electronic vouchers in this program has increased efficiency and the ability to track and distribute nets since 2007. Although the program has been successful, to date, electronic voucher redemption varies widely across the country and it has not been clearly established as to what barriers exist for women who receive electronic vouchers in the program. This cluster-randomized trial was designed to examine perceived barriers to electronic voucher redemption among pregnant women and to evaluate if educational and personalized text messages around electronic voucher redemption and bed net usage will increase electronic voucher redemption when directed at pregnant women who receive electronic vouchers in the currently existing program.
Each year, ~85.3 million pregnant women are at risk of becoming infected with Plasmodium falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical immunity to malaria, malaria infection in pregnancy leads to placental malaria (PM), often without clinical symptoms in the mother. The systemic and placental changes that occur with malaria in pregnancy can adversely affect the developing fetal brain, an fetal brain injury strongly affects long-term childhood neurodevelopmental (ND) and behavior but there are no published studies to date on the impact of malaria in pregnancy on childhood ND. This study, conducted in Uganda, will address the effects of malaria in pregnancy and childhood ND and define mechanisms by which malaria may lead to ND impairment including micronutrient deficiencies. ND outcomes will be measured by the following neuropsychological and behavioral tests: Mullen Scales of Early Learning, the Color Object Association Test, the Early Childhood Vigilance Test, the Behavior Rating Scales, the Behavior Related inventory of Executive Function and the Child Behavior Checklist. These tests will be given at 12, 24, 36, and 60 months of age. This study will be nested in an ongoing Ugandan IRB approved interventional trial (PROMOTE-II) (NCT02163447). Blood sampling is being conducted in the PROMOTE-II protocol for research purposes. Some of that blood will be used to test for micronutrient deficiencies as well as other immune responses to malaria.
Since 2000, annual numbers of malaria cases in South Africa have sharply declined to about 5,000, with case numbers fairly stable since 2007. The principal malaria prevention strategy has consisted of generalised Indoor Residual Spraying (IRS) of all houses in malaria endemic districts. As recent case data indicate that the levels of transmission in many districts have been reduced to very low levels, the continuation of untargeted IRS in areas where there is little or no evidence of recent transmission may be unwarranted. Efforts to eliminate malaria will only be sustainable if mass prevention efforts can be scaled down in an evidence-based manner, whilst maintaining or enhancing high sensitivity of the surveillance system of the disease. This trial will provide scientific evidence for targeted malaria prevention responding to localised transmission in pre-elimination settings, compared to continuation of generalised IRS of all houses. Two methods of IRS delivery for community malaria prevention will be compared through an open-label cluster-randomised trial consisting of two study arms with 30 clusters per arm of approximately 8,000 inhabitants per cluster. Comparison is on the basis of non-inferiority by showing that malaria incidence in the targeted IRS arm is no higher than malaria incidence in the generalised IRS arm within a specified margin of difference, and on the basis of superiority showing that the proportion of houses targeted for spraying is higher in the intervention than the reference arm. Neighbourhood investigation in response to each locally acquired case in the intervention arm, and comparison neighbourhoods in the reference arm, will include testing for antibody sero-conversion to malarial antigens to assess whether cases arise in communities with long term exposure to malaria parasites. The trial will be carried out in the South African provinces of Limpopo and Mpumalanga, in localities which have average reported incidence of malaria of <5 cases per 1000 per annum over the past five years.
This study will be conducted in a single centre, as an open single dose two parallel cohorts design with oral doses of MMV390048 administered in healthy male and female subjects between 18 to 55 years of age. Subjects will be screened within 28 days prior to entering the study. On Day 1 of the study each subject will receive one of the two MMV390048 prototype formulations, at a dose of 40 mg with 240 mL of water. Subjects will be discharged on Day 3 after 48h post-dose and they will attend the unit for follow-up visits on Days 5, 7, 10, 14, 19, 26 and 29.
Background: People with malaria often show altered immune responses to many illnesses and vaccines. This means that the malaria might cause immune suppression. It is not clear how or which vaccines are impacted by malaria. It is also not clear if the impacts are such that people should be preemptively treated before they get vaccinations. Researchers want to see if there is a link between taking an antimalaria drug prior to getting vaccines and the immune response to those vaccines. To do this, they will study people who are taking part in certain NIAID studies. Objectives: To compare the proportion of PD1+ CD4 T cells among all T cells in vaccine immune responses in adults who have or have not received antimalarials prior to getting a Menactra vaccine. Eligibility: Healthy Malian adults who: Were previously enrolled in NIAID Protocol 13-I-N109 or 15-I-0044 Reside in Bancoumana and neighboring villages Are not pregnant Design: Participants will be screened with a physical exam. Participants will get the vaccines listed below as part of Protocol 13-I-N109 or 15-I-0044. This study will follow their schedule. At each visit, participants will give a blood sample. They will also have a physical exam. Each visit will last 1 to 2 hours. At visit 1, participants will get a hepatitis vaccine. Two weeks later, participants may get the antimalarial drug Coartem . They will be chosen at random. Two weeks later, participants will get Menactra . Participants will have 5 follow-up visits after they get Menactra . The study will last up to 4 months. ...
The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that were selected in 2014 on the basis of the malaria incidence rate, the heterogeneity of transmission between villages in the health post catchment areas, their proximity, and the availability of historical data from before 2014. Malaria elimination strategies were already implemented in the same health posts in 2014 and are still ongoing, thus this protocol aims to strengthen these activities. Seven health posts with similar characteristics but with a slightly lower incidence rate were chosen as controls. It will be implemented in all villages in the six intervention health posts and it will consist of investigating all passively detected cases (index cases) and conducting focal test and focal drug administration (FT/FDA) with dihydroartemisinin-piperaquine (DHAP) in all index case and neighboring households with a positive RDT. All household members in households with a positive RDT will be treated, regardless of their RDT results. Impact of the enhanced Step D on malaria incidence and prevalence will be evaluated using before-after comparison and compared to the change in the control health posts and the operational aspects will be assessed for subsequent scale up.
The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which: - Two or fewer participants (< 30%) experience hemolysis; - No participant experiences a drug-related serious adverse event; and - No participant requires a blood transfusion.
This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime. All vaccines will be administered intramuscularly. Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp. Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp. Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 1x10^8 pfu eight weeks later. Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 2x10^8 pfu eight weeks later. The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples. Healthy volunteers will be recruited in Oxford and Southampton, England.