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NCT ID: NCT03143218 Recruiting - Malaria,Falciparum Clinical Trials

Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ)

Start date: April 17, 2017
Phase: Phase 3
Study type: Interventional

A double-blind, individual randomised trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether the malaria vaccine RTS,S/AS01 is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful protection when given together with SMC. The primary trial end-point will be the incidence of clinical episodes of malaria detected by passive case detection. The costs of each intervention and its delivery will be determined and compared

NCT ID: NCT03130114 Recruiting - Diarrhea Clinical Trials

Antibiotics for Children With Severe Diarrhoea

Start date: May 13, 2017
Phase: Phase 3
Study type: Interventional

Although the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the 90 days following an episode of acute diarrhoea appear at least as high as mortality that occurs during the acute episode. The long-term benefits of antibiotic administration may result from direct antimicrobial effects on pathogens or from other incompletely understood mechanisms including improved nutrition, alterations in immune tolerance or improved enteric function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children with severe disease may offer the opportunity to significantly reduce diarrhoea associated deaths in the 90 days following presentation for acute diarrhoea and may also improve growth. The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered in a specific, targeted fashion to young children (< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study will evaluate the ability of the intervention to reduce mortality within 90 days of the acute diarrhoeal episode, and improve nutritional status over the same period.

NCT ID: NCT03114137 Recruiting - Sickle Cell Disease Clinical Trials

Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose

Start date: March 2012
Phase: N/A
Study type: Observational [Patient Registry]

The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

NCT ID: NCT03035305 Completed - Malaria Clinical Trials

Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali

Start date: August 2016
Phase: N/A
Study type: Interventional

SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali. The objective of this study is to determine whether the association SMC and LNS reduces the number of confirmed malaria cases among children 6-59 months during the monthly SMC distribution sessions.

NCT ID: NCT02996695 Recruiting - Clinical trials for Plasmodium Falciparum Infection

PfSPZ Challenge With Prophylaxis in Mali

Start date: April 6, 2017
Phase: Phase 1
Study type: Interventional

Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides sterile protection against naturally-occurring malaria in malaria-experienced adults. The study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive, residing in Bougoula Hameau and surrounding villages, Mali.

NCT ID: NCT02974608 Recruiting - Malaria Clinical Trials

Impact of Malaria on Pregnant Women in Ouelessebougou, Mali

Start date: November 17, 2016
Phase: N/A
Study type: Observational

Background: Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa, malaria continues to be the main cause of death in young children and pregnant women. Researchers want to find out more about how malaria affects pregnant women and their babies. Objectives: To study the rate of miscarriage and stillbirth during the second and third trimesters among women in a certain district in Mali. To study rates of malaria infection over time among pregnant women and children in this area. Eligibility: Pregnant women of any age and pregnancy stage and their newborns. They must live in Ouelessebougou, Mali. Children up to 10 years old who live there. Design: Information about the study will be shared at community meetings, during visits to the health centers, and during census updates. Participants will read and sign a consent form. Pregnant women will be screened to see if they are eligible. They may have a urine test. They may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures of the body. Women will be enrolled in the study after they have their babies. Participants may have a physical exam. Some participants will provide a finger/heel prick blood sample. Participants will complete a questionnaire. They will be asked about: Medical history Antimalarial and other interventions Socioeconomic status Their pregnancy Previous pregnancies Health of their newborn...

NCT ID: NCT02942277 Recruiting - Malaria Clinical Trials

Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali

Start date: October 6, 2016
Phase: Phase 1
Study type: Interventional

Background: Researchers are looking for new ways to control and eradicate malaria. They want to test vaccines to block malaria transmission in adults in Mali. These vaccines work by inducing antibodies in a person. The antibody is then taken up with blood by a mosquito that bites the person. This blocks parasite development in the mosquito. This stops malaria transmission to another person. Objective: To test the safety, reactogenicity, immunogenicity, and transmission-blocking activity of the vaccines Pfs25M-EPA and Pfs230D1M-EPA with AS01 in Malian adults. Eligibility: Healthy Malians ages 18-50 living in certain areas in Mali who: Are not pregnant or breastfeeding Are not infected with HIV, Hepatitis B and Hepatitis C Do not have evidence of immunodeficiency Do not have history of severe allergic reaction or anaphylaxis Design: Participants will be screened with: Medical history Physical exam Malaria Comprehension Exam Blood and urine tests Electrocardiogram (for participants in certain study groups) Participants will be randomly assigned to a study group. Participants will be monitored for 12-16 months. For the first 7 months, they will have between 1 and nine visits a month. The number depends on the month and on what group they are in. For the rest of the months, they will have 1 monthly visit. Each visit includes a physical exam. Most include blood tests. Participants will get 3 doses of a study or comparator vaccine. They get the vaccine through an injection in the upper arm. This occurs at their first visit, then 1 month later, and then 5 months later. Participants will be followed for at least 6 months after the last vaccine. If participants develop an injection site rash or reaction, photographs may be taken of the site.

NCT ID: NCT02858011 Recruiting - Child Malnutrition Clinical Trials

The Effect of a Cash Transfer Program on Household Welfare and Child Nutritional Status in Mali

Start date: September 2014
Phase: Phase 4
Study type: Interventional

In the last two decades, cash transfer (CT) programs have emerged as a popular approach to long-term poverty alleviation. While the main goal of cash transfer programs is to reduce poverty, they also have the potential to improve many development outcomes, such as health and education. While many studies, mainly in Latin America and Asia, have investigated the impacts of CTs on poverty and food security and have, for the most part, found positive impacts, less is known about the impacts of CTs in Africa south of the Sahara, and, in particular, West Africa. Moreover, despite the fact that cash transfers have been shown to lead to decreases in poverty, improvements in household food security, and increases in health service utilization, impacts on children's nutritional status (including anthropometric measures) are generally small (Manley, Gitter, and Slavchevska 2013). Consequently, policymakers and governments are left with the question of how to design social safety nets, such as cash transfers, to achieve greater impact on diet quality, health, and nutrition. The overall goal of this research is to generate evidence and knowledge on an integrated program implemented by the Government of Mali that includes a combination of cash transfers and targeted nutrition interventions. The information generated will inform program implementers and policymakers about best options to improve food security and nutrition among vulnerable groups and individuals in West Africa. Specifically, the main objectives of the research are 1. To provide evidence on the contribution of integrated social transfer programs to enhancing household welfare, food security, dietary diversity, and maternal and child nutrition in West Africa. 2. To test different features and combinations of cash transfers with targeted nutrition interventions, and assess their impact on food security and maternal and child nutrition and health outcomes in Mali. 3. To generate knowledge regarding the pathways of impact of these different program packages, identify the most effective and efficient modalities in the context of Mali, and derive lessons learned for other countries in the region. The research entails two study designs: i) a repeated cross-sectional survey (baseline, midline and endline) in a sample of 1,440 children between 6 and 24 months of age, mainly to asses the program's impact on child nutrition and health outcomes; ii) a panel study following a cohort of 2,880 children over 3 years mainly focusing on the evaluation of household welfare outcomes. The study will be conducted in the 96 communes where the Jigisemejiri program is being implemented, situated in 5 regions of Mali: Sikasso, Koulikoro, Segou, Mopti and Kayes.

NCT ID: NCT02831023 Completed - Malaria Clinical Trials

Phase 2 Efficacy Study of Primaquine and Methylene Blue

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the most efficacious transmission blocking drug regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be the proportion of mosquitoes infected pre and post-treatment, assessed through membrane feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary endpoint will be a within group comparison between the mean of the pretreatment infectivity (Day 0) and infectivity at 7 days post first dose.