Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments...
MalariaA community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).
Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria)...
MalariaThe aim of this study is to evaluate the role of azithromycin as a possible combination partner for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile.
Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections
Malaria,FalciparumThis study will assess the efficacy of Pyramax administered for three-day, two-day or one day, in clearing a P. falciparum infection in asymptomatic carriers. .
Drug Combinations of Atovaquone-Proguanil (AP) With ACT
Plasmodium Falciparum Malaria (Drug Resistant)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.
Phase 1 Study of the Safety and Immunogenicity of a Malaria Transmission-blocking Pfs25-Pfs25 Conjugate...
MalariaMalaria Vaccines1 moreBackground: Malaria, a disease transmitted by mosquitoes, affects millions of people with the highest frequency, morbidity, and mortality in infants and young children. Plasmodium falciparum and Plasmodium vivax, the most common and severe forms of malaria, have host- and stage-specific proteins that can induce immunity to the disease. Vaccines against stages that infect mosquitoes will prevent the spread of malaria. Researchers have developed a vaccine composed of a single protein, Pfs25, to induce antibodies in the human host that will be ingested by the mosquito and prevent the malaria parasite from reproducing and stop transmission of the disease. Because Pfs25 is present only in the mosquito, humans do not develop antibodies to this antigen even in endemic areas. Repeated injections of this vaccine may be necessary. Objectives: - To establish the safety and optimal dosage of a malaria vaccine developed with the Pfs25 protein. Eligibility: - Healthy adults between 18 and 49 years of age who have never had malaria or received a malaria vaccine. Design: Two doses of Pfs25 conjugate (10 micrograms and 25 micrograms) will be evaluated in this study. Participants will receive only one of these doses in order to provide the best scientific data for evaluation. To determine eligibility, participants will provide a medical history and have a physical examination, and will provide blood and urine samples to test for HIV/AIDS, hepatitis, and other conditions that would prevent them from participating. Eligible participants will receive one injection of the vaccine. The injection will be followed 30 minutes later with a temperature reading and an inspection of the vaccine site. Upon leaving the clinic, participants will receive diary forms, a digital thermometer, a ruler, and instructions about how to take their temperature and to measure redness and swelling (if any) at the injection site. About 6 hours later, and daily for 3 days, participants will take their temperature at home and examine the injection site. Participants will be examined at the clinic at 48 to 72 hours and on day 7 after an injection. A blood sample will be taken 1 week after immunization. - Participants will receive a second and third injection of the same vaccine at 6-week intervals, and will follow the same recording procedure given above. Further blood samples will be taken at regular intervals for up to 12 months after the vaccination, as directed by the study researchers.
Study to Investigate the Induction of an Protective Immune Response to Malaria
Falciparum MalariaThe objective of the study is to induce a protective immune response against malaria in healthy human volunteers. The different parts of the immune response will then be studied.
Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by...
Uncomplicated Plasmodium Falciparum MalariaThe purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs. The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.
Comparing Chemoprevention Approaches for School-based Malaria Control
Malaria,FalciparumAnemia in ChildrenThis is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent screening and treatment (IST) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (RDT). Arm 2: Intermittent preventive treatment (IPT) - all students will receive treatment. Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.
Comparing Chemoprevention Drugs for School-based Malaria Control
Malaria,FalciparumAnemia in ChildrenThis is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence in young children sleeping student's households to assess the impact on transmission.
TES of Artemether-lumefantrine for Pf in the Philippines in 2017-2018
Malaria,FalciparumMalaria RecrudescenceThe emergence and spread of drug resistance is a major obstacle to combating malaria. The World Health Organization (WHO) recommends that regular efficacy monitoring should be undertaken by all malaria endemic countries that have deployed artemisinin combination therapy (ACT), to help early detection of drug resistant strains of the parasite and contain their rapid spread. Artemether-lumefantrine (AL) has been the first-line antimalarial drug against uncomplicated Plasmodium falciparum malaria in the Philippines since 2009, with primaquine as an anti-relapse drug. The objective of this study is to assess the safety and efficacy of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in the Philippines. The study was conducted in three (3) municipalities (Bataraza, Brooke's Point, and Rizal) of Palawan. Single-arm prospective study of a 28-day follow-up was conducted from February 2017 to December 2018 according to the revised WHO 2014 drug efficacy study protocol. Study subjects were consenting individuals seeking care at the selected Rural Health Units, who were aged >6 months old to 59 years old with confirmed uncomplicated P. falciparum infections. AL was administered for 3 days according to body weight (Days 0, 1 and 2) and primaquine 0.75 mg/kg body weight single dose was given on Day 3 following the National Treatment Guidelines.