There are about 50 clinical studies being (or have been) conducted in Benin. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.
In the last few years, early treatment of HIV-infected individuals, or "treatment as prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative people at very high-risk of acquiring the infection (PrEP) have emerged as highly promising biological preventive interventions to tackle the HIV pandemic within the framework of combination prevention, a multi-component strategy that has been promoted for the last five years. In West Africa, the evidence strongly suggests that female sex workers (FSWs) contribute very disproportionally to the HIV spread. This is why the investigators propose this TasP and PrEP demonstration project in Benin, where our group has been involved in HIV prevention research in the sex work milieu for the last two decades. After a run-in phase for community preparedness and the development of a specific education program on adherence, the investigators plan to recruit 100 HIV-infected FSWs in the TasP component of the project (these women will receive a first-line antiretroviral treatment (ART) regimen as per the Benin guidelines) and 250 HIV-negative FSWs in the PrEP component (these women will receive Truvada®). The recruitment period will last for one year, followed by an additional one year of follow-up, for a total follow-up period varying between 12 and 24 months, depending on when a given woman is recruited in the study. During follow-up visits every three months, the investigators will closely monitor treatment adherence and changes in sexual behaviour, including the use of viral load testing among TasP participants and Truvada® plasma level testing for PrEP participants, as well as detection of prostate-specific antigen (PSA) and Y-chromosome DNA in vaginal fluids in all participants. The investigators will evaluate the feasibility of TasP and PrEP through a set of indicators, including uptake, coverage, adherence, condom migration, occurrence of side effects and development of drug resistance, whereas mathematical modeling will be used to predict the potential impact of both interventions in the sex work milieu and the general population, based on the actual set of indicators observed. The study will be completed by an economic evaluation of the interventions and a cost-effectiveness analysis. Finally, the investigators will disseminate the results to the study population and to the Beninese health authorities and ensure the broad implementation of these interventions in Benin if the demonstration project shows that they are feasible and relevant.
A randomised, double-blind single-dose (loose combination) study in patients with uncomplicated Plasmodium falciparum malaria. The study will test for efficacy/futility through analyses, using Bayesian methodology. Adults and children will be included through progressive step-down in age following safety analyses. This study investigates the efficacy exposure-response of OZ439/PQP combination in the target populations and if it meets its efficacy objectives, will inform dose setting for Phase III studies.
Malaria is a common disease in Africa and a major health problem. Pregnant women are also at risk of malaria. Malaria in pregnancy is life threatening to both the mother and the baby she is carrying. It can result in the destruction of the mother's blood and in babies with a lower birth weight than normal, making them less healthy in their first years of life. These risks are even higher in women having their first pregnancy. When a woman is pregnant she should go to the Antenatal clinic (ANC) for care. Usually the ANC health staff gives the woman intermittent preventable treatment (IPTp-SP) against malaria. This drug helps protect the woman against getting malaria. Each pregnant woman should receive at least 2 doses of this drug during their pregnancy; thus, they should go the ANC at least 2 times during their pregnancy. However, many women still do not go often to the ANC for health care during their pregnancy. This study would like to see whether community health workers (CHW) can work with pregnant women to encourage them to attend ANC more often. Also, the CHW will test a pregnant woman every month for malaria with a rapid test. If a woman has malaria, the CHW will treat her in her home instead of the woman having to go a health clinic for treatment. The woman will be treated with a different drug than the drug that is given at the ANC visits. Our hypothesis is that this will improve the care and management of malaria during pregnancy and this will improve the health of women and their newborns. To see whether this strategy improved the health of women and their newborns, we will take a small piece of the placenta at delivery to test for malaria and we will weigh the baby. We will test this strategy in multiple communities. We will compare this to pregnant women in communities where this strategy was not followed, thus where pregnant women received standard care. Participants will be pregnant women. There are no direct benefits for participating in the study, except the outcome of our research question that is possible health benefits in the intervention group. The drugs involved are tested safe in pregnant women from second trimester on.
The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.
This is a WHO-sponsored trial. Combination therapy with streptomycin and rifampicin has been the standard antibiotic treatment for M. ulcerans infection since 2004. In March 2010, a WHO Technical Advisory Group recommended that a trial be carried out to develop a fully oral treatment for the disease. Although the current treatment is effective, injection with streptomycin is a problem. Several small observational studies (published and unpublished) have shown that a fully oral treatment is promising. This WHO sponsored study will be a randomized, controlled open label non-inferiority phase II/III, multi-centre trial (1 centre in Benin and 4 centres in Ghana), with two parallel treatment groups. The ultimate goal is to search for an effective alternative treatment to the current standard WHO-recommended therapy for all forms of Buruli ulcer, which includes injections of streptomycin with inherent logistic, operational and safety disadvantages. Financial and material support: 1. American Leprosy Missions, USA 2. Raoul Follereau Foundation, France 3. MAP International, USA 4. Sanofi, France 5. 7th Framework Programme of the European Union: BuruliVac project (241500) 6. Aranz Medical Limited, New Zealand
Iron deficiency (ID) with or without anemia is still a main public health problem in sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as children below 5 years of age and women of reproductive age. The etiology of ID is multifactorial; but major causes are low iron dietary bioavailability and intake from monotonous cereal-based diets aggravated by chronic parasitic infections such as malaria and soil-transmitted helminthes. Approaches such as dietary diversification, supplementation with pharmacological iron doses, public health measures (e.g. deworming, malaria control) and food fortification with different iron compounds have notably reduced morbidity and mortality caused by ID but have not been universally successful. Biofortification is a new promising approach to combat micronutrient deficiencies such as ID. It is defined as the process of increasing the content and bioavailability of essential nutrients such as iron in crops by traditional plant breeding and/or genetic engineering. Pearl millet is a staple food for many people living in different areas of West Africa (e.g. Northern Benin) and India, two parts of the world, where ID is still widely prevalent. Therefore, pearl millet was one of the crops targeted for iron biofortification by HarvestPlus. To improve human iron status successfully, the additional iron gained through biofortification has to be at least as bioavailable as the iron in regular peal millet varieties. For that reason we are planning an iron absorption study where we will investigate the iron bioavailability from an iron-biofortified millet variety and compare it with the iron bioavailability from a regular-iron millet variety and from regular-iron millet fortified post-harvest with ferrous sulfate (FeSO4). Iron absorption will be determined by incorporation of labeled iron into erythrocytes, at least 14 days after the administration of the test meals containing labeled iron (stable isotope technique). The three different test meals based on 1) regular-iron, 2) iron-biofortified and 3) post-harvest iron-fortified millet will be administered as multiple meals i.e. each study participant will consume each test meal for a period of 5 days (2 portions/day; one in the morning, one for lunch). Twenty apparently healthy Beninese women with a low/marginal iron status (serum ferritin < 25 ;g/L), non-anemic or mildly anemic (hemoglobin >90 g/L), 18-30 years of age with a body weight < 65 kg and normal body mass index will be included in the study. The results of the study will provide important insights on the iron bioavailability from regular, biofortified and post-harvest fortified staple crops such as pearl millet when feeding multiple meals as part of a more complex diet. The results can be applied to different meals based on pearl millet such as the West African millet pastes or the Indian flat breads.
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations in developing country rural settings with poor access to potable water. To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc enriched water) a double blind controlled field efficacy trial will take place over a period of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc enriching filter), placebo (filter) and control group (disinfection tables). During the trial the following outcomes will be monitored: zinc status and growth rate of the participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment of water, and modality and consistency of use of the LSF-device by the study population. The study hypotheses are: 1) the use of the LSF-device will reduce microbiological contamination of the household water, 2) the use of the LSF-device will increase zinc intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device will increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea episodes in participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy outcome and lower frequency and length of diarrhea episodes in participating pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea episodes in participating households members.
Primary Objective: To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria Secondary Objectives: - To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs) - To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A