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NCT ID: NCT03187834 Not yet recruiting - Child Development Clinical Trials

Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso

ARMCA
Start date: July 4, 2017
Phase: Phase 4
Study type: Interventional

The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome. This study is designed to estimate the effect of antibiotic consumption on microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and nasopharyngeal microbiome and resistome following a short course of antibiotics will be measured.

NCT ID: NCT03176719 Not yet recruiting - Anemia Clinical Trials

Non-specific Effects of Vaccination on Mortality and Morbidity

NOVAK
Start date: June 5, 2017
Phase: N/A
Study type: Observational

It has long been recognized that the positive effects of vaccination on childhood mortality cannot be solely attributed to a decline in the disease targeted by the vaccine. These so-called non-specific effects of vaccination have so far mostly been linked to mortality. However, it has been suggested that non-specific effects may also effect morbidity and nutritional status. This study aims to further explore the correlation between vaccination, susceptibility to infectious diseases (particularly malaria and bacterial infections), nutritional status and immunity. With this prospective cross sectional study among healthy individuals in rural west-Africa we aim to address several research questions at the same time. This study will assess the influence of (time-point of) vaccination on morbidity, mortality and immune status among healthy individuals in a rural sub-Saharan African setting. Secondly, to explore the prevalence of subclinical malaria, iron deficiency anemia, sickle cell anemia and thallasemia among a healthy rural sub-Saharan African population. And finally to assess normal hemocytometry values among a healthy rural sub-Saharan African population.

NCT ID: NCT03143218 Recruiting - Malaria,Falciparum Clinical Trials

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

RTSS-SMC
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: NCT03027505 Recruiting - Clinical trials for Global Acute Malnutrition (GAM)

Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso

MUAC-Only
Start date: January 2017
Phase: N/A
Study type: Interventional

MUAC only is a non-inferiority trial with external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso. The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include : 1. A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain. 2. A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.

NCT ID: NCT02967003 Recruiting - Clinical trials for Hemorrhagic Fever, Ebola

Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Start date: May 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.

NCT ID: NCT02925403 Active, not recruiting - Malaria Clinical Trials

A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, With Matrix-M1 Adjuvant

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study in which healthy adult volunteers will be given either an experimental Malaria vaccine or a saline control vaccine. Each volunteer will receive three vaccinations in total. Volunteers will be randomly allocated to one of three groups: Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will receive a high dose of the Malaria vaccine on days 0, 28, and 56. Group 3 will receive a saline solution on days 0, 28, and 56.

NCT ID: NCT02851108 Completed - Malaria, Falciparum Clinical Trials

Methylene Blue Against Falciparum Malaria in Burkina Faso

BlueACTn
Start date: October 2016
Phase: Phase 2
Study type: Interventional

Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum malaria treatment in African children: A randomised controlled trial Elimination has become the goal of malaria programmes in an increasing number of endemic countries and regions. As resistance against artemisinin compounds has recently started to emerge in South-East Asia, there is a clear need to develop alternative malaria drug combinations. Adding another anti-malarial with a short half-life such as methylene blue to standard ACT could be a strategy to prevent artemisinin resistance development. Moreover, adding a gametocytocidal drug to ACT reduces the probability of transmission of P. falciparum parasites including drug-resistant parasites. Objectives: The primary objective of this trial is to investigate the safety of artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young children with uncomplicated falciparum malaria in Burkina Faso.

NCT ID: NCT02716935 Active, not recruiting - Growth Retardation Clinical Trials

Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

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

The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.

NCT ID: NCT02714686 Active, not recruiting - Contraception Clinical Trials

Evaluation of a Mass Media Family Planning Campaign on the Uptake of Contraceptive Methods in Burkina Faso

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

In this experiment, the investigators will study the effect of a mass media family planning campaign on contraception related behavior. The study takes place in Burkina Faso, a country with an average of six children born to each woman, and a modern contraceptive prevalence rate (mCPR) estimated at 15% in 2010 at the national level, as per the Demographic Health Survey (DHS) 2010 report on Burkina Faso. The aim of this study is to provide robust evidence on the efficiency and cost-effectiveness of an intense three-year mass media campaign focused on family planning. The campaign will diffuse messages about the financial and health benefits of family planning, and information on the different types, sources, advantages, and disadvantages of different contraceptive methods. The study will target women at the age of reproduction in rural areas of Burkina Faso to measure the effect of the intervention on total and modern contraceptive prevalence rates, perceptions of family planning, contraception-related behavior, and general gender norms. Burkina Faso is an ideal place to evaluate the impact of a radio campaign because a high percentage of the rural population listens to local radio which is in the local language. Radio station areas are distinct because they target very local languages and their reach is limited by government decree, which allows for the implementation of a randomized control trial.

NCT ID: NCT02669823 Recruiting - Clinical trials for Tropical Infectious Diseases

Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region

PALUBAC
Start date: April 2016
Phase: N/A
Study type: Observational

Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate clinically. This poses a particular threat in low resource areas, where bBSI is often not diagnosed due to the unavailability of rapid diagnostic means. Even if used appropriately, the sensitivity of blood culture to diagnose bBSI is estimated to be around 50%. To counter the high mortality rate associated with bBSI, antibiotics are often prescribed without microbiological confirmation. Sysmex Company has developed technology that enables the rapid diagnosis of malaria using a venous blood sample. In addition algorithms based on hematological parameters can be used to monitor disease severity and progression, as well as guide further diagnostic testing based on differences seen in these parameters between various types of disease. The algorithms have been developed and tested in adult populations from different industrialized countries and in one Asian population. However no data are available neither from pediatric patients, nor from the sub-Saharan setting where the epidemiology of infectious diseases is very different from the tested settings. The objective of the study is to: 1) Assess the sensitivity and specificity of the Sysmex hematology analyzer based on the new technology to diagnose malaria in subjects older than 3 months, who present with an acute severe febrile illness in a malaria endemic area in sub-Saharan Africa 2) Test and optimize the value of Sysmex analyzers in disease diagnosis and monitoring in children older than 5 years and adults, who present with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa, to differentiate between severe malaria and bBSI, or a combination of these infections. 3) Explore the value of Sysmex analyzers in disease diagnosis and monitoring in children between 3 months and 5 years of age, who present with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa.