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Malaria clinical trials

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NCT ID: NCT01024426 Completed - Malaria Clinical Trials

Impact of Enhanced Health Facility Care in Uganda

Start date: December 2010
Phase: Phase 4
Study type: Interventional

The investigators propose to assess whether an intervention to build capacity and improve delivery of drugs and diagnostics at government-run health facilities improves the health of children and quality of care delivered, as compared to 'standard care' currently available at health facilities, supplemented by services provided through the private sector and community-based interventions. The target population will be divided into 20 clusters, defined as the catchment area of lower-level public health facilities. Clusters will be randomized to the health facility intervention (HFI) or to standard care delivered from government-run health facilities, supplemented by services provided through the private sector and community-based interventions. The intervention is designed to address barriers to delivering quality care at health centers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs. Outcomes will be measured in three distinct populations: (1) cross-sectional surveys of children under 15 years randomly selected from households within the clusters; (2) a cohort of children under five randomly selected from households within the clusters and followed for 2 years; and (3) patients attending all government-run health facilities, including children under five and their caregivers participating in exit interviews on selected days every six months. The primary outcome of the study is prevalence of anemia in children under five.

NCT ID: NCT01023399 Completed - Malaria Clinical Trials

Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Start date: November 2009
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later. The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine

NCT ID: NCT01019408 Completed - Malaria, Falciparum Clinical Trials

Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan

ECQNWFP
Start date: November 1993
Phase: Phase 4
Study type: Interventional

The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.

NCT ID: NCT01018459 Completed - Malaria Clinical Trials

Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkina Faso

Start date: April 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4 groups. Members of each group (12 per group) will receive an increasing dose of vaccine or placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive placebo. Study procedures include: physical exam, urine sample, and blood samples. Participants will be involved in study related procedures for about 13 months.

NCT ID: NCT01017770 Completed - Clinical trials for Uncomplicated P. Falciparum Malaria in Children

Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso

ACTE
Start date: September 2008
Phase: Phase 4
Study type: Interventional

Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.

NCT ID: NCT01003314 Completed - Malaria Clinical Trials

A Study of the Safety and Effectiveness of Two New Malaria Vaccines

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1. These vaccines consist of inactivated viruses which have been modified − so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response), to provide protection against malaria infection. This protection has been demonstrated in nonhuman studies. Although these vaccines have not been given to humans before, similar vaccines using the same viruses with different malaria genes have been given to humans before. In these studies, the vaccines have been shown to be safe. They have also provided evidence from laboratory tests of immunogenicity. In this study the investigators main aim is to ensure these new vaccines given alone and in combination are safe. The investigators will increase the dose of the first vaccine (AdCh63 MSP1) given to volunteers if the initial dose is safe. The investigators also wish to ensure that challenging a small number of volunteers who have received both vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge) is safe. Sporozoite challenge has been widely used in humans to test the effectiveness of malaria vaccines and is considered a well established, reliable, predictable and safe system.In the study the investigators will also look for evidence of immunogenicity of these new vaccines, and whether there is any delay to developing malaria following sporozoite challenge. The study will be conducted at the University of Oxfords Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take place at the insectary at Imperial College, (Infection and Immunity Section)in London.

NCT ID: NCT01002833 Completed - Malaria Clinical Trials

Comparison of Three Plasmodium Falciparum Isolates in an Experimental Human Malaria Infection

TIP1
Start date: April 2010
Phase: N/A
Study type: Interventional

Plasmodium falciparum isolates display a wide genetic diversity with possibly different properties to induce immune responses. These properties could directly influence the ability to induce protective efficacy. Since 1998 an experimental human malaria infection model at the Radboud University Nijmegen Medical Center (RUNMC) has been very successful in answering questions with regards to immunological mechanisms of human Pf infection. To date only the NF54 strain of Pf has been deployed in this Nijmegen model. However, investigation of heterologous Pf challenge is not only highly informative for our basic understanding of induction of immune responses but also provides an essential model for protective capacity testing in the clinical development of candidate malaria vaccines. Recently, the parasite culture laboratory of the RUNMC has been able to overcome technical hurdles to produce infectious mosquitoes of two genetically different isolates from different geographical regions to increase the portfolio for Phase IIa trials. These isolates, PfA and PfB will be compared with the NF54 strain for parasitic, immunological and clinical features in humans.

NCT ID: NCT01002066 Completed - Malaria Clinical Trials

Effectiveness Of Rapid Diagnostic Tests in the New Context of Low Malaria Endemicity in Zanzibar

RDTACT
Start date: May 2010
Phase: N/A
Study type: Observational

The purpose of this study is to study the effectiveness of wide scale RDT use at the primary health care level in previously high malaria endemic area during malaria pre-elimination phase for improved targeting of anti-malarial drugs, malaria surveillance and epidemic alertness.

NCT ID: NCT01001871 Completed - Anemia Clinical Trials

Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

Start date: November 2009
Phase: N/A
Study type: Interventional

Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas. The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area. The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.

NCT ID: NCT00993031 Completed - HIV Infections Clinical Trials

Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women

PROMOTE-PIs
Start date: December 15, 2009
Phase: Phase 3
Study type: Interventional

This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria. This study also enrolls the infants of these women at the time of delivery.