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Malaria clinical trials

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NCT ID: NCT05652504 Suspended - Malaria Clinical Trials

Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)

Start date: June 26, 2024
Phase: Phase 1
Study type: Interventional

Background: Malaria is a disease that affects many people in Africa. It is caused by germs carried by some mosquitoes. A person bitten by an infected mosquito will get malaria. Most malaria infections cause only mild symptoms or none at all, but sometimes the disease can be deadly. Malaria can also harm pregnant women. They may lose their pregnancies or deliver too early, and the mother and newborn may die. An experimental malaria vaccine (PfSPZ) has shown some protection against malaria infection. It is not yet known if PfSPZ is safe for pregnant women. Objective: To test the PfSPZ vaccine in pregnant women. Eligibility: Healthy women aged 18 to 34 years at 14 to 32 weeks gestation with 1 fetus. Design: The study will be in Mali. Participants will have about 40 clinic visits over 20 months. They will be screened. They will have an ultrasound exam and a test of their heart function. They will have blood and urine tests. Participants will receive an injection through a needle into a vein on 3 visits over 1 month. Some will receive the PfSPZ vaccine; others will be injected with salt water. They will not know which injection they are getting. After the last injection, participants will visit the clinic every 2 weeks. They will have blood tests at each visit. After giving birth, participants and their infants will visit the clinic every 2 weeks for 4 months; then they will have visits each month until the infant is 1 year old. The infant will be examined and will have blood tests at each visit.

NCT ID: NCT05218304 Suspended - Diabetes Clinical Trials

Baromètre Santé Adulte 2021-2022

Start date: July 26, 2021
Phase: N/A
Study type: Interventional

In 2021-2022, Agence Sanitaire et Sociale Nouvelle Calédonie (ASSNC) is undertaking the "Baromètre Santé Adulte" for the third time. This study is carried out this year in collaboration with WHO and Institut Pasteur de Nouvelle Calédonie (IPNC). The main objective of this investigation is to describe the current levels of chronic disease risk factors in the adult population of New Caledonia aged from 18 to 64 years old. This study will also help to estimate prevalence of certain diseases (diabetes, hypercholesterolemia, renal failure), seroprevalence of arboviruses (dengue fever, Zika, chikungunya and Ross River) malaria as well as the seroprevalence of SARS-CoV-2. Repeated regularly, these surveys allow the ASS-NC to capitalize on population indicators, to compare them according to socio-demographic characteristics, to identify groups at risk, to provide changes in health behaviors and to strengthen analytical capacities in order to adapt the guidelines for public policies and prevention programs.

NCT ID: NCT04280692 Suspended - Malaria,Falciparum Clinical Trials

Controlled Human Malaria Infection Transmission Model - Phase A

CHMI-TransMod
Start date: August 22, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is to develop a model to test the efficacy of vaccines and/or drugs designed to block transmission of malaria to mosquitoes and to identify the targets of transmission-blocking immunity to malaria.

NCT ID: NCT00616304 Suspended - Clinical trials for Severe Falciparum Malaria

Safety and Preliminary Efficacy of L-arginine in Severe Falciparum Malaria

ARGISM
Start date: February 2008
Phase: Phase 2
Study type: Interventional

Background: Mortality from severe malaria remains ~15% despite the use of the most rapidly parasiticidal antimalarial therapy, artesunate. Adjunctive treatments may improve outcome. Our overall goal is to determine if adjunctive treatment with L-arginine is safe and improves outcomes in severe malaria. In studies to date, we have shown that L-arginine is safe in moderately severe malaria, increases nitric oxide production and improves endothelial function. We now propose to extend these studies to patients with severe malaria. Aims: To determine the safety, preliminary efficacy, pharmacokinetics and pharmacodynamics of L-arginine infusion in severe malaria. Hypothesis: L-arginine will improve endothelial function, lactate clearance time and tissue oxygen delivery compared to saline with no clinically significant adverse effects. Methods: Based on previous pharmacokinetic modeling and simulations, we propose a phase 2A randomised controlled trial of L-arginine vs saline in severe malaria, each given over 8 hours. If safety is demonstrated this will be followed by a phase 2B open-label study of 24-hour infusion of L-arginine in severe malaria with safety and preliminary efficacy compared with the 8 hour infusions given in phase 2A. The primary outcomes will be the improvement in endothelial function and lactate clearance in patients given L-arginine infusion compared with those who received saline. Among the secondary outcomes will be safety and the effect of L-arginine vs saline on tissue oxygen delivery (NIRS). Data from both phase 2A and 2B will be used to generate a pharmacokinetic/ pharmacodynamic model.

NCT ID: NCT00465257 Suspended - Malaria Clinical Trials

Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar

Start date: May 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.

NCT ID: NCT00442403 Suspended - Malaria Clinical Trials

Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria

Start date: April 2002
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen administration supplemented with dehydroepiandrosterone sulfate against drug-resistant malaria.

NCT ID: NCT00126971 Suspended - Malaria Clinical Trials

Chlorproguanil-Dapsone in Pregnant Women

Start date: July 2005
Phase: Phase 1
Study type: Interventional

Controlling malaria during pregnancy is a vital strategy in decreasing maternal and child mortality in Africa. There are data from clinical trials and program evaluations in stable transmission areas that show that intermittent preventive treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal anemia, placental parasitemia, and low birth weight (LBW). SP is also the first-line drug for the case-management of malaria in pregnancy. Resistance to SP, however, is increasing rapidly in East and Central Africa and compliance to the rescue treatment, 7-days of oral quinine, is low. There is an urgent need to find effective, safe and practical alternative drugs for the treatment of malaria in pregnancy. The synergistic antifolate combination chlorproguanil-dapsone (CD), has recently become available. It is inexpensive, well tolerated, is given as single daily treatment doses for 3 days, and is effective in the treatment of drug-resistant falciparum malaria. The investigators propose a small pharmacokinetic study of CD to determine if current fixed combination CD tablets provide an adequate dosage in pregnancy. Such a study is a necessary precursor to any large Phase II trials to further evaluate the safety and efficacy of CD for use in pregnant women. To accomplish this, a group of 66 parasitemic pregnant women in this open label trial will receive CD and be sampled by venipuncture at two of the seven follow-up visits scheduled for pharmacokinetic analyses, such that 11 patients are sampled at each of 12 time points. To serve as a reference, 66 non-pregnant women with symptomatic malaria will also be treated with CD and will have identical pharmacokinetic (PK) analyses performed. Pregnant women greater than or equal to 20 weeks gestation with P. falciparum parasitemia on peripheral blood film will be given an insecticide-treated net (ITN) and will receive CD (1.5 or 2 tablets daily for 3 days, depending on weight). All study drug dosing will be observed. Women will be examined, adverse events recorded, and blood samples collected at days 0, 1, 2, 3, 7, 14, 21, and 28 after treatment, and thereafter every 14 days until delivery. Women will be further randomized to receive additional blood draws for pharmacokinetic analyses using a modified rich PK schedule. Each woman will only have 2 additional blood draws. Women at delivery will have peripheral and placental blood films prepared. Newborns will be weighed, examined, and gestational age determined. Women requiring antimalarial treatment for parasitemia at any point between enrollment and delivery will be treated with quinine. Adverse effects will be assessed at each scheduled visit, any sick visits during the study, and at delivery.