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Malaria clinical trials

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NCT ID: NCT00863408 Completed - Malaria Clinical Trials

Estivation of Malaria Vector Mosquitoes in the Sahelian Region of Mali

Start date: March 3, 2009
Phase: N/A
Study type: Observational

Background: - P. falciparum, one of the most virulent forms of malaria, causes more than 300 million episodes of malaria and 1 million deaths each year. The spread of drug-resistant parasites, insecticide-resistant mosquitoes, and persistent socioeconomic conditions of poverty compound the difficulties of malaria as a major global health problem. New means of disease and vector control are vitally needed. - Several promising strategies rely on targeting mosquito populations when they are most vulnerable, such as during the dry season when mosquitoes find it difficult to reproduce. Large regions of the West African country of Mali have prolonged dry seasons (up to 8 months), during which mosquito populations dramatically decline within a month after the rainfall ceases. Clearly, mosquitoes can survive the dry season (as evident from their robust numbers during the wet season) but the process that enables them to do so remains unknown. Targeting the small and fragile mosquito population at the end of the dry season could reduce or eliminate the numbers of mosquitoes in certain regions, providing great benefits for communities in dry regions. Objectives: - To determine if common malaria-carrying mosquitoes survive the dry season in the Mali village of Thierola by estivation (going dormant, or hibernating, during dry periods). - To identify and examine mosquitoes that were marked with special paint during a previous protocol, if these marked mosquitoes are captured during the investigation. Eligibility: - All activities in this protocol will take place in Thierola village, Banamba district, Koulikoro region, Mall, West Africa. The village was chosen because it is isolated from other communities by at least 6 km and is a small community of less than 300 inhabitants living in 90 houses. - Participants will be healthy adult men between 18 and 65 years of age. Design: - Thirty adult men who live in Thierola will be recruited to participate as mosquito collectors for the human-baited trapping method and will work in teams of two. - The first collector will expose his lower legs to attract human-seeking mosquitoes. Using a mouth aspirator, the second collector will collect the mosquitoes as they land on the first collector's legs. - The collections will be conducted both indoors and outdoors from 6 p.m. to 6 a.m. the following morning for 14 consecutive days. - All study volunteers will be trained in proper collection technique and supervised throughout the study by a mobile team led by the study investigators. Volunteers will be monitored for signs of malaria and treated accordingly if they develop symptoms of the disease. - Researchers will collect mosquito samples at the end of the dry season (April-May) and at the start of the rainy season (May-June). - Mosquitoes collected in the study will be analyzed by NIH researchers to learn more about how they survive during the dry season.

NCT ID: NCT00857077 Completed - Malaria Clinical Trials

Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

Start date: September 2000
Phase: N/A
Study type: Interventional

Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through Expanded Programme on Immunisation vaccination clinics.

NCT ID: NCT00853281 Completed - Malaria Clinical Trials

A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam

Start date: March 2004
Phase: N/A
Study type: Interventional

In Central Vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. Untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffer a significantly higher number of clinical attacks. Thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. Hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection. The Investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets).

NCT ID: NCT00852423 Completed - Clinical trials for Malaria in Pregnancy

Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria

PREGACT
Start date: June 2010
Phase: Phase 3
Study type: Interventional

Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.

NCT ID: NCT00852371 Completed - Malaria Clinical Trials

Intermittent Preventive Treatment of Malaria in Schoolchildren

Start date: February 2008
Phase: Phase 3
Study type: Interventional

This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

NCT ID: NCT00850655 Completed - Malaria Clinical Trials

Genetic Association Mapping of Malaria Resistance in Anopheles Gambiae

Start date: March 2008
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00845533 Completed - Clinical trials for Uncomplicated Malaria

Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso

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

This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.

NCT ID: NCT00844207 Completed - Malaria Clinical Trials

A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine

AZCQ
Start date: February 2009
Phase: Phase 1
Study type: Interventional

The primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.

NCT ID: NCT00840502 Completed - Malaria Clinical Trials

Ultrasound Study in Pregnant Women With Malaria

UPS
Start date: February 10, 2009
Phase:
Study type: Observational

Most of the neonatal deaths that occur worldwide every year are associated with low birth weight (LBW), caused by intrauterine growth restriction (IUGR) and/or preterm delivery. Accurate assessment of fetal growth and gestational age for timely identification and management of growth restriction are therefore public health priorities, especially in developing countries where 98% of all neonatal deaths occur. Every year, more than 50 million women become pregnant in malaria endemic regions. Malaria infection at any time during pregnancy reduces birthweight. However, little is known about the relationship between the timing of infection during pregnancy and the extent of the impact on birth weight. The mechanisms by which malaria causes LBW also remain unclear. Reduced placental blood flow, placental changes, red blood cell changes, severe anaemia and pro-inflammatory cytokines have all been implicated. In this proposed, longitudinal, observational, minimal risk study, which will take place in SMRU antenatal clinics on the Thai-Burmese border, the effect of malaria infection during pregnancy on fetal growth will be determined. Women will be screened before 13+6 weeks of gestation and followed with regular ultrasound examinations during pregnancy. When a woman has a malaria infection an extra ultrasound scan will be done to measure growth retardation or placental blood flow changes. Bloodsamples will be taken to detect changes in red blood cell properties and putative markers of malaria infection. For this study the maximum amount of blood taken during pregnancy is 13 cc in an uninfected woman. For each malaria episode an additional 7 cc blood will be taken. After delivery a placenta and a cord sample will be taken to detect placental changes. The investigators aim to recruit four hundred pregnant women over the course of two years. This study involves minimal risk to participants as ultrasound examination is part of routine antenatal care in many countries in the world.

NCT ID: NCT00832754 Completed - Malaria Clinical Trials

Restricting the Use of Artesunate Plus Amodiaquine Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial

RDT-ACT
Start date: March 2009
Phase: Phase 4
Study type: Interventional

Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in <48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.