Active clinical trials for "Malaria"

Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Optimism that an effective malaria vaccine can be developed is derived in part from the observation that repeated Pf infections can induce protective immunity; however, the mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study is to apply systems biological tools to an observational cohort in an area of intense seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired malaria immunity. This year-long observational-cohort study of 700 individuals (3 months and 25 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be detected by passive and active surveillance. Immune parameters of malaria-protected and -susceptible individuals will be assayed from blood samples collected at strategic time points relative to the malaria season. The primary objective is to identify genome-wide expression profiles induced by Pf infection that are associated with protection from malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific antibody profiles that are associated with protection from malaria using a protein microarray representing 2000 Pf proteins (40 percent of the Pf proteome). Exploratory objectives for this study are to compare the magnitude and quality of the Pf-specific CD4 plus T cell response in malaria-protected and -susceptible individuals and determine how this response varies with age and among individuals before, during, and after malaria season, as well as compare various immune parameters in Pf-infected and uninfected individuals at the end of the dry season to investigate host immune factors associated with chronic asymptomatic Pf infection....

This study will collect blood samples for use in laboratory studies of malaria. The World Health Organization reports that 40 percent of the world's population is at risk for malaria, mostly in the poorest countries. It is a serious disease caused by parasites. Each year, 300-500 million infections lead to more than a million deaths. However, there are traits in red blood cells (erythrocyte) that protect people against malaria. In this study, polymorphism refers to the various kinds of red blood cell traits. The sickle cell trait is an example of one that seems to offer a natural survival advantage in children where malaria is common. Researchers at the Laboratory of Malaria and Vector Research are investigating ways in which the blood cell traits can offer such protection, and new knowledge gained can bring about medical advances. Of particular importance is studying how the malaria organism, Plasmodium, survives inside different red blood cells. A steady, consistent, and reliable supply of fresh whole blood is necessary for testing. Patients 18 to 65, weighing more than 110 lbs. and who do not have anemia or known HIV, Hepatitis C, or Hepatitis B may be eligible for this study. Patients will undergo a medical history and general assessment including vital signs of temperature, heart rate, and blood pressure. Blood will be collected from a vein in the arm, or rarely a vein in the hand. A complete blood count, or CBC, will be done to ensure that blood levels are sufficient and that blood donation is safe for a patient to do. Patients need to have enough hemoglobin, the part of red blood cells that transports oxygen throughout the body. The blood will also be tested to confirm the type of red blood cell traits of patients. About 1 to 8 tablespoons may be collected, but most blood samples will be small, that is, 1 to 4 teaspoons. After the patients' first visit, sessions will take 5-20 minutes. Blood collection will total no more than 2 cups from a donor during any 6-week period. Although the frequency of blood donations is not known at this time, it is unlikely that a patient will be asked to donate blood more than four times a year. It may be important for patients to undergo a repeat CBC or tests for blood chemistry if results are needed for research. Risks associated with blood collection are considered minimal. They include discomfort, occasional bruising or bleeding at the puncture site, and faintness. In this study, it is possible that a small amount of blood may be stored for future research, to help the researchers to learn more about malaria. There are no plans for the results from the various research laboratory tests to be made available to patients or to their private doctors. However, patients in this study may discuss the results of routine medical tests with the study investigators. Some of the blood collected will be tested for genetic conditions. Through genetic testing, researchers can learn more about how health or illness may be passed on to people by their parents, or from people to their children. All results of tests will remain confidential. Blood samples will be labeled by code, and reference to patients' identities will be protected. Participants will receive $50 for each blood donation. This study will not have a direct benefit for participants. Future research that uses their blood samples will help researchers to learn about malaria as well as how to prevent or treat the disease.

The purpose of this study is to see if children, who develop coma from malaria, are not making enough of a vitamin-like chemical, tetrahydrobiopterin (BH4), which is required for the brain to function normally. This information may help to identify new ways to treat malaria in the future. Study participants will include 512 children, ages 6 months to 6 years. Participants will be placed into one of 4 groups: well children; children with mild malaria; children without malaria, but with a medical problem involving the brain that requires a lumbar puncture for diagnosis (a procedure in which a needle is placed into an area surrounding the spinal cord and a sample of cerebral spinal fluid is removed); and children with a severe form of malaria affecting the brain called cerebral malaria. Study procedures will include blood samples, urine samples and lumbar puncture, only if necessary for diagnosis as part of standard practice procedures. Participants will be involved in study related procedures for up to 3 weeks.

This study, sponsored by the National Institutes of Health and the University of Bamako in Mali, Africa, will examine factors that may protect against progression of malaria from mild to severe disease. Infection with the malaria parasite causes disease ranging in severity from mild or no symptoms to severe. A better understanding of what factors protect against disease progression may help scientists develop improved methods of disease prevention and treatment. The objectives of this study are to: Identify differences in protective factors for severe malaria in Malinke children residing in two Mali villages, Kela and Kangaba. Genetic variations in hemoglobin proteins called HbS and HbC appear to confer protection against severe disease in some children but not others. HbC appears to protect young Malinke children living in Kela, but not in nearby Kangaba, while HbS protects children in Kangaba but not in Kela. In addition, deficiency of an enzyme produced by red blood cells called G6PD protects males, but not females, from severe malaria. Investigate how fetal hemoglobin (HbF) may protect against malaria in infants and determine how HbS, HbC, G6PD deficiency, and beta-thalassemia trait affect the rate of HbF decline during the first 2 years of life. Children under 11 years of age who seek medical care at Kangaba or Kela health centers for symptoms of malaria may be eligible for this study. Each will be screened with a medical history, physical examination and blood test. In addition, healthy infants born to women referred to field site clinics may be enrolled for the newborn study. Participants undergo the following procedures: Children with mild malaria are treated with artesunate and amodiaquine. Those with severe malaria are treated with quinine. Blood is collected by finger prick every day for 4 days to evaluate the response to treatment and for genetic testing. Some blood is stored for future research related to malaria. Newborns have a heel or finger prick at 1, 3 and 6 months to collect a small blood sample for genetic testing. In addition, at the time of birth, a small amount of blood is collected from one of the blood vessels of the placenta. Some infants may be followed up to 2 years, with additional drops of blood taken at 12, 18 and 24 months. Some of the blood is stored for future research related to malaria.

The purpose of this study is to find out what effect malaria in the mother has on the development of her child's immune system response to malaria and whether being exposed to malaria in the womb makes a child more likely to get malaria. The study will also assess the effect that exposure to malaria in the womb has on the child's growth and development over the first three years of life. Study participants will include 480 healthy pregnant women (greater than or equal to 15 years of age), their healthy offspring, 20 healthy people from the United States with no malaria exposure or disease and 40 adult Kenyans who have previously been exposed to malaria or have malaria with no signs of infection. Study procedures will include an ultrasound (procedure to assess the baby's growth and development in the womb), blood, urine, and stool collections. Newborns will be examined at birth, and at 6, 12, 18, 24, 30 and 36 months of age.

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. ...

This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.

The Malaria Heart Disease Study is a prospective longitudinal cohort study of a random sample of approximately 1200 individuals from the state of Acre in Brazil. The overall hypothesis is that patients who have (i) previously suffered from a malaria infection or (ii) patients with ongoing symptomatic malaria will benefit from having an echocardiogram and blood tests performed as a screening tool to diagnose early cardiac impairment and prevent future cardiovascular disease.

The purpose of this study is to determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from P. vivax malaria infection during pregnancy.

Uganda's under-five mortality is high, currently estimated at 90/1000 live births (Uganda Bureau of Statistics 2011). Poor referral of sick children that seek care from the private sector is one of the contributory factors. The proposed intervention aims to improve uptake of referral advice for children that seek care from private facilities (registered drug shops/private clinics). The project will be implemented in Mukono district, central Uganda selected because a recent concluded trial in the district showed that drug shop vendors (DSVs) adhere to diagnostic test results, treat appropriately and refer sick children; although uptake of referral is poor. The main reasons attributed to the observed poor referral were negative attitude towards referral forms from drugs shops by the health workers at referral facilities,perceptions of poor quality of care at referral facilities and costs involved (Hutchinson. 2012; Hutchinson et al. 2013 in press).. Thus the proposed project is a follow up to address these factors with the aim to improve uptake of referral. This project is in line with the Uganda's Health sector and USAID Mission's health priorities of strengthening the health system. Critical barriers in the implementation of child survival interventions are poor quality of care in the private sector and timely referral and uptake of referral advice at community level. These barriers may be attributed to inadequate training of providers in the private sector (in diagnosis and management of childhood illnesses); inadequate supervision and regulation; poor linkages and collaboration between the public and private sectors; and non-existent linkages between community structures and the private sector. The barriers will be addressed through an intervention with three components; i) VHTs will be trained to do community sensitization and initiate community discussions aimed at identifying community support mechanisms for financial hardship (to be community led and managed) - e.g. communities to be encouraged to establish community credit/insurance schemes for referral VHTs will register children and facilitate follow up of sick children ii) supervision of providers in the private sector to diagnose, treat and refer sick children, iii) regular meetings between the public and private providers (convened by the district health team) to discuss the referral system.