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NCT ID: NCT03459157 Recruiting - HIV/AIDS Clinical Trials

Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)

Start date: November 20, 2017
Phase: N/A
Study type: Interventional

This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa. An interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo. All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.

NCT ID: NCT03400930 Recruiting - Clinical trials for Severe Acute Malnutrition

Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

Start date: January 1, 2017
Phase: N/A
Study type: Observational

INTRODUCTION In 2014, 50 million children under 5 suffered from acute malnutrition, of which 16 million suffered from SAM, most of them living in sub-Saharan Africa and Southeast Asia. SAM children have higher risk of mortality (relative risk between 5 and 20). It is an underlying factor in over 50% of the 10 - 11 million preventable deaths per year among children under five. At present, 65 countries have implemented WHO recommendations for SAM treatment (both in-patient for complicated cases and outpatient for uncomplicated cases) but these programs have very low coverage, reaching only around 10 - 15 % of SAM children. In 2009 the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) issued a joint statement in an effort to harmonize the application of anthropometric criteria for SAM diagnosis and monitoring in child aged 6 - 59 months; the statement presents recommended cut-offs, and summarizes the rational for the adoption, of the following two anthropometric criteria: 1. Weight-for-Height Z-Score (WHZ): "WHO and UNICEF recommend the use of a cut-off for weight-for-height of below -3 standard deviations (SD) of the WHO standards to identify infants and children as having SAM." Additionally, analysis of existing data show that children with a WHZ < -3 have a highly elevated risk of death. 2. Mid-Upper Arm Circumference (MUAC): "WHO standards for the MUAC-for-age show that in a well-nourished population there are very few children aged 6 - 59 months with a MUAC less than 115 mm. Children with a MUAC less than 115 mm have a highly elevated risk of death compared to those who are above. Thus it is recommended to [use] the cut-off point [of] 115 mm to define SAM with MUAC." GENERAL OBJECTIVE To generate new evidence on pathophysiological process, nutritional needs and risks associated with different types of anthropometric deficits in children under 5, in order to optimize the diagnosis and treatment of SAM. SPECIFIC OBJECTIVES - To compare nutritional status, metabolism, pathophysiological process and risks in different types of SAM anthropometric diagnosis, with or without concomitant stunting (growth retardation). - To analyze the extent to which current SAM treatment is promoting recovery and healthy growth in different categories of children. - To evaluate the relevance of current discharge criteria used in nutrition programs and their association with metabolic recovery, in different age groups and among those who are stunted. - To test novel rapid tests of emerging biomarkers predicting long-term outcomes and mortality risk in the field. METHODOLOGY A wide range of supplementary information related to nutritional status, body composition, metabolic and immune status, including emerging biomarkers of metabolic deprivation and vulnerability, will be collected besides anthropometry during prospective observational studies. They will be collected with minimum level of invasiveness, compatible with field work requirements in the humanitarian context. Phase 1: Cross-sectional surveys. Phase 2: Prospective cohort studies involving SAM children between 6 months and 5 years old. Children admitted as SAM at the nutrition centers will be enrolled into the cohort. The follow up duration will be at least three months. EXPECTED OUTCOMES - Confirmation of current hypotheses related to: 1. possible misdiagnosis of SAM made by MUAC or WHZ criteria, 2. varying degree of severity and need for admission to treatment of the different types of diagnosis, 3. underlying heterogeneity of the pathophysiology. - Generation of new algorithms for the assessment and classification of malnourished children, based on the combined use of emerging biomarkers and anthropometric measures, or on the modification of anthropometric criteria. - Generation of new treatment paradigms based on the predictive value of biomarkers in combination with traditional anthropometric measures. This will enable us to assess the power of current treatment regimens to promote long-term weight gain and growth and will allow us to tailor treatment to the physiological needs of the child.

NCT ID: NCT03269279 Recruiting - Clinical trials for Medical; Abortion, Fetus

Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso

Start date: May 20, 2017
Phase: Phase 3
Study type: Interventional

The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.

NCT ID: NCT03231449 Active, not recruiting - Stroke Clinical Trials

A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa

Start date: February 1, 2017
Phase: N/A
Study type: Observational

FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.

NCT ID: NCT03199547 Recruiting - Neonatal SEPSIS Clinical Trials

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

Start date: October 21, 2017
Phase: Phase 3
Study type: Interventional

Though maternal and neonatal health are high priority areas for international development, maternal and neonatal mortality remain unacceptably high. Worldwide there are 1 million maternal and 4 million neonatal deaths every year and half of them occur in sub-Saharan Africa. Post-partum and neonatal severe bacterial infections, namely sepsis, are leading causes of maternal and neonatal deaths in sub-Saharan Africa. Newborns can be infected during labour - when passing through the birth canal - and also during the first days/weeks of life, as a consequence of the close physical contact with the mother, when the latter carriers bacteria. As the mother is an important source of bacterial transmission to the newborn, treating mothers with antibiotics during labour should decrease their bacterial carriage and therefore lower transmission to the newborn. As carriage is a necessary step towards severe disease, this intervention should in turn result in the lower occurrence of severe bacterial disease and mortality during the neonatal period. In many high-income countries, pregnant women are screened during pregnancy for vaginal carriage of Group B Streptococcus, the bacteria responsible for the vast majority of neonatal sepsis in the developed world. If women are carriers, they are treated with intravenous antibiotics during labour to decrease the risk of severe disease to their off-spring. Although this intervention has been successful in developed countries, infrastructure and resource limitations in regions like sub-Saharan Africa prevent both screening and use of intravenous antibiotics. Also, in Africa several bacterial pathogens are responsible for neonatal sepsis and the antibiotics needed in the continent should cover a wider number of bacteria; and ideally cover also bacteria responsible for severe post-partum disease in the mother. We will conduct a large trial in West Africa, The Gambia and Burkina Faso, with the main objective of determining if a single dose of an oral antibiotic given to women during labour decreases newborn mortality. The trial will also assess the effect of the antibiotic on lowering newborns and maternal hospitalization during the first week's post-partum. We have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already been used for elimination of other prevalent diseases such as trachoma. This antibiotic is safe, requires a single oral administration, has no special storage requirements and has the potential to eliminate most of the bacteria commonly causing severe disease in newborns and post-partum women in the continent. Very important this antibiotic is not widely used in clinical care in the continent, and therefore, any temporal increase of resistance induced by the intervention should not have implications on current treatment guidelines. Before going to the large trial proposed here (12,500 women to be recruited), we have generated robust preliminary data on the effect of the intervention in a proof-of-concept trial conducted in The Gambia (829 women and their offspring recruited). We found that in fact, babies born from mothers who had taken this antibiotic during labour were less likely to carry bacteria that can potentially cause severe disease. These babies were also three times less likely to have bacterial skin infections or umbilical infections, both highly common among African newborns. Besides, fever or mastitis (again both very common in the region) during the post-partum period were four times lower among mothers who had taken the antibiotic during labour. Such trial confirmed our hypothesis of impact on bacterial transmission but it was too small to assess the effect of the antibiotic on mortality and hospitalizations. The preliminary trial also showed that women from the azithromycin group were less likely to need antibiotics for treatment infections during the puerperal period, decreasing then the pressure on the scarcity of antibiotics available in the continent. The advantages of our approach are its simplicity, low cost and the possibility of protecting both mothers and babies with the same intervention.

NCT ID: NCT03187834 Active, not recruiting - Child Development Clinical Trials

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

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 Recruiting - Anemia Clinical Trials

Non-specific Effects of Vaccination on Mortality and Morbidity

Start date: June 17, 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 Active, not 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: NCT03027505 Recruiting - Clinical trials for Global Acute Malnutrition (GAM)

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

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.