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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 (artemisinin-based combination therapy) 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 Completed - 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 Completed - 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 1, 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.

NCT ID: NCT02663700 Completed - Clinical trials for Plasmodium Falciparum Infection

Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso

Start date: April 7, 2016
Phase: Phase 1
Study type: Interventional

This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The study duration shall be 34 months and subject participation duration shall be 15-26 months.

NCT ID: NCT02661464 Terminated - 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 31, 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: NCT02658253 Completed - Malaria Clinical Trials

Trial to Evaluate the Safety and Immunogenicity of a Placental Malaria Vaccine Candidate (PRIMVAC ) in Healthy Adults

PRIMALVAC
Start date: January 2016
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions The safety profile will included local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria

NCT ID: NCT02626286 Completed - HIV Infection Clinical Trials

Feasibility and Interest of a HIV Quarterly Preventive Global Care in Men Who Have Sex With Men in Sub-Saharan Africa

CohMSM
Start date: June 2015
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the feasibility and interest of a HIV quarterly preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help reducing HIV incidence in this key population, their female partners, and the general population. This interventional, open label, multicenter, multidisciplinary cohort study will be conducted in Burkina Faso, Ivory Coast, Mali and Togo. All participants will receive a HIV quarterly preventive global care including: i) data collection on health status, symptoms of sexually transmitted infections (STI) and sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv) counselling adapted for MSM, and v) the provision of condoms and lubricants.

NCT ID: NCT02564523 Completed - Clinical trials for Hemorrhagic Fever, Ebola

Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults

Start date: November 6, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.

NCT ID: NCT02509481 Completed - Malaria Clinical Trials

Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study

RIMDAMAL
Start date: June 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether repeated ivermectin mass drug administrations to Burkinabé villagers, performed in three week intervals over the rainy-season, is well-tolerated and safe, and also effective in reducing local malaria transmission and thus clinical malaria episodes in treated village children.