Active clinical trials for "Malaria"

Background: - Malaria is a leading cause of morbidity and mortality in Uganda, accounting for more than a quarter of all outpatient visits at health facilities, 20 percent of hospital admissions, and about 10 percent of inpatient deaths. Children under 10 years of age, pregnant women, and HIV-infected individuals bear the greatest burden of disease. To provide baseline information for future malaria vaccine research, development, and testing, researchers are interested in collecting malaria infection data from the Rakai district in southern Uganda. Objectives: - To assess the epidemiology of malaria infection among children aged 6 months to less than 10 years and adults living in same households with children in Rakai district, Uganda. Eligibility: - Children between 6 months and 10 years of age, as well as their primary caregiver and an additional randomly selected adolescent or adult resident of the household, from the Rakai district of Uganda. Design: Participants will have monthly household visits for a 1-year surveillance period. Each visit will include a structured interview/questionnaire of the primary caregiver or legal guardian of the child and clinical and laboratory assessments of each child, the primary caregiver, and the additional adolescent or adult resident of the household. The questionnaire will ask about malaria treatment and prevention measures. Children will provide a blood sample for testing. Individuals (children or adults) who are diagnosed with malaria or anemia during the course of the study will be recommended for treatment. Researchers will also track usage of the district health clinic and hospital services to link medical records for study participants.

Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia. Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas. This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).

The purpose of this study is to determine the importance of key blood group molecules in the clinical outcome of Plasmodium falciparum malaria infection in children.

This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in Bancoumana, Mali. Information from the study will help in planning trials of malaria vaccines. Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may be eligible for this study. Candidates are screened with a physical examination and blood tests. Participating children are visited at home for a total of about 17 visits to see if they are well. They come to the clinic every month during the 7-month study for a clinical evaluation, including a blood sample obtained by finger prick to test for malaria. Some of the blood collected may be stored and used for research. Children who become sick with malaria are treated for the disease.

Clinical pneumonia is a leading cause of pediatric hospitalization. The etiology is generally bacterial or viral. Prompt and optimal treatment of pneumonia is critical to reduce mortality. However, adequate pneumonia management is hampered by: a) the lack of a diagnostic tool that can be used at point-of-care (POC) and promptly and accurately allow the diagnosis of bacterial disease and b) lack of a prognostic POC test to help triage children in need of intensive assistance. Antibiotic therapy is frequently overprescribed as a result of suspected bacterial infections resulting in development of antibiotic resistance. Conversely, in malaria-endemic areas, antibiotics may also be "underprescribed" and children with bacterial pneumonia sent home without antibiotic therapy, when the clinical pneumonia is mistakenly attributed to a co-existing malaria infection. The investigators previously identified combinations of protein with 96% sensitivity and 86% specificity for detecting bacterial disease in Mozambican children with clinical pneumonia. The investigators' prior work showed that it is possible to identify biosignatures for diagnosis and prognosis using few proteins. Recently, other authors also identified different accurate biosignatures (e.g., IP-10, TRAIL and CRP). In this study, the investigators propose to validate and improve upon previous biosignatures by testing prior combinations and seeking novel combinations of markers in 900 pediatric inpatients aged 2 months to 5 years with clinical pneumonia in The Gambia. The investigators will also use alternative case criteria and seek diagnostic and prognostic combination of markers. This study will be conducted in Basse, rural Gambia, in two hospitals associated with the Medical Research Council Unity The Gambia (MRCG). Approximately 900 pediatric patients with clinical pneumonia aged 2 months to 5 years of age will be enrolled. Patients will undergo standard of care test and will have blood proteins measured through Luminex®-based immunoassays. Results of this study may ultimately support future development of an accurate point-of-care test for bacterial disease to guide clinicians in choices of treatment and to assist in the prioritization of intensive care in resource-limited settings.

Prospective cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clinics. At the point of care, study staff will collect capillary blood samples and conduct malaria microscopy (both the standard of care and study specific research-grade microscopy) and two index tests: the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT. Venous blood will be collected and transferred to the laboratory where the reference PCR assay and three comparator RDTs will be run. The index RDTs will also be repeated in the laboratory. All clinical management of study participants will follow the standard of care for malaria diagnosis in Brazil and will be based on the standard microscopy result. Confirmatory testing may also be conducted, such as typing and sequencing of Plasmodium genes and antigens of interest, including but not limited to HRP2, HRP3, and pLDH as well as the human inflammatory response marker CRP. The lay provider/health worker participants will include intended users of the index tests. They will be surveyed to assess index test usability through a questionnaire to assess label and packaging comprehension as well as results interpretation.

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have markedly improved our ability to control malaria; yet they have inherent limitations which include low sensitivity in Plasmodium vivax detection and inability to detect hrp2/3 gene deleted Plasmodium falciparum parasites. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. A partnership between RapiGEN, FIND, and the Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing five novel malaria RDTs with improved pLDH and HRP2 detection. RapiGEN has also developed three novel malaria RDTs - BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), BIOCREDIT Malaria Ag Pf (pLDH/HRP2) and BIOCREDIT Malaria Ag Pf (pLDH) - to address these drawbacks. The BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) is a combo test that detects P. falciparum and P. vivax on a single device. BIOCREDIT Malaria Ag Pf (pLDH/HRP2) targets both PfLDH and HRP2 antigens in P. falciparum; and BIOCREDIT Malaria Ag Pf (pLDH) has improved detection of pLDH in P. falciparum. In countries with circulation of hrp2/3 deleted P. falciparum malaria parasites or high P. vivax burden, these improved RDTs may be invaluable in malaria elimination. This study is a prospective and retrospective evaluation of RapiGEN's BIOCREDIT Malaria Ag RDTs in malaria-endemic countries to assess their clinical performance for detection of malaria. The purpose of this study is to provide a high level outline of the study design and conduct to support the collation of a data package for WHO Pre-Qualification proposed study.

Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria. A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children.

Historically, Plasmodium vivax has been termed "benign" due to its non-life threatening clinical course and since the 1800's this view has been cultivated as demonstrated by the use of the term "benign tertian malaria" to describe the infection.However over the last 15 years, more severe P. vivax malaria is being reported, causing concern that severe P. vivax malaria is under diagnosed. The definition of severe P. vivax malaria borrows from P. falciparum and is primarily one of exclusion. Species PCR (polymerase chain reaction) is the only way to prove P. vivax mono-infection but is expensive and requires skilled staff and technology. In resource constrained settings, diagnostic testing is not available for detection of most non-malarial infections further affecting the ability to determine whether severe symptoms are due to P. vivax malarial infection or a concomitant one. Retrospective studies from India, Pakistan, Indonesia, Papua New Guinea and Sudan support the existence of severe P. vivax malaria. However, inconsistent methodologies, definitions of severity, and use of diagnostic tests to exclude concomitant infection do not allow for standardised assessments for severe P. vivax infection across studies. A review by Baird, highlighted that the risk of being classed as suffering from severe illness was only minimally higher in P. falciparum than in P. vivax, but was unable to combine the data as a meta-analysis. The primary reported symptoms for severe P. vivax included severe anaemia particularly in children, severe thrombocytopaenia, respiratory distress, neurological syndromes (coma or seizures), renal and hepatic failure. Prospective studies have shown similar results. Tjitra et al showed that 23% (675 of 2,937) patients admitted with microscopically diagnosed P. vivax infections in Papua, Indonesia had severe disease and that the risk of severe malaria was significantly higher when admitted with P. vivax than with P. falciparum. In studies from Papua New Guinea, few differences between the clinical presentation of P. falciparum and P. vivax were found in children with severe malaria. This appears to be similar in populations from Sudan, Pakistan and India. In contrast, in Thailand, anecdotal observations note a low prevalence of severe P. vivax infections. The WHO criteria to assess severe P. falciparum have been extrapolated to P. vivax. In the 2015 WHO malaria guidelines some criteria now account for P. vivax, such as removing a minimum parasitaemia when assessing for severe anaemia. Whilst these criteria may not be the most sensitive tool to define severe P. vivax infections, it is used for this purpose. It has been suggested that additional clinical information may be necessary to define truly severe P. vivax cases. In order to describe the characteristics of the severity of P. vivax infections in north-western Thailand, we will perform a retrospective review of annual reports of the outpatient database, the inpatient database and eligible inpatient medical records from 2001 to 2016. The WHO malaria guidelines and additional clinical information will be used to assess the severity of infection and thus, a rate of severe P. vivax can be determined.

This is a study of the genetics of malaria transmission by the mosquito vector in Africa, Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected with malaria. DNA extracted from infected mosquitoes will be analyzed genetically by microsatellite and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that control mosquito resistance to malaria parasites.