There are about 191 clinical studies being (or have been) conducted in Mali. 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.
NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks. While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment. The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (Côte d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a "case-control" design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries
Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa. HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases: - First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers; - Second, a 48-week phase, during which: - Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement; - Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART. Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.
Background: - Malaria is caused by small germs carried by mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year. About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to find a safe vaccine that helps prevent malaria. Objectives: - To see if a new malaria vaccine is well tolerated and effective. Eligibility: - Healthy adults 18 35 years old who are not pregnant and live in Mali. Design: - Participants will be screened with medical history, physical exam, and blood test. They will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals. - Study participation will last about 1 year. - Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses of placebo. - Doses will be given through a needle in the arm directly into the bloodstream. Then participants must stay at the clinic for 2 hours. - After each dose, participants will return to the clinic several times for blood tests and physical exam. - A week before the first dose and 2 weeks after the last, participants will take a full course of anti-malaria drugs. - If a participant gets malaria during the study, they will take another course of anti-malaria drugs.
The general objective of the study is to answer to the question: "Is the current dose of AL less efficacious in the severely malnourished compared to the non-severely malnourished children, and is PK in cause?" We aim to assess whether the current treatment dose is adequate for children with severe acute malnutrition, and we hope results will guide further recommendations for malaria treatment in this specific population.
Background: - Malaria is caused by small parasites carried by some mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells. Most malaria is mild, but some children develop severe malaria, which kills about 660,000 people annually. About 9 in 10 who die of malaria are Sub-Saharan African children, most under 5 years old. Scientists can save many lives if they find out how to prevent or relieve severe malaria. Objective: - To know if a common medicine called activated charcoal can reduce severe malaria symptoms. Eligibility: - Children 2 to 11 years old with mild malaria who live in Kenieroba, Mali. Design: - For the first 2 days and nights, participants will stay in the hospital. - They will have their medical history taken, and a physical exam. - Blood will be drawn from a thin tube inserted in their hand or forearm. This will be done 3 times overall. A drop of blood will be taken from a finger prick 12 times overall. - An antimalarial drug will be injected into the tube in the arm 4 times. Each time the drug is given, participants will drink a small cup of either water or activated charcoal. - For the following 3 days, participants will take an antimalarial pill. - On day 7, participants will visit the hospital. A drop of blood from a finger prick will be tested for malaria parasites.
Behavioral change is a key ingredient for successful adoption of better sanitation practices in rural Africa. Sanitation programs have, for some time now, incorporated the need to raise awareness and emphasize the benefits of toilet usage. These endeavors, often combined with subsidies linked to toilet construction by households, seek to create a demand for sanitation goods. Yet, progress in securing the desired outcomes from sanitation programs has been slow. Moreover, benefits of sanitation largely take the form of externalities, which individuals do not take into account when making their own decisions about investments. This makes sanitation promotion at the household level particularly challenging. A new approach to sanitation entails a shift away from the provision of subsidies for toilets to individual households and a promotion of behavioral change at individual-level towards emphasizing collective decision-making in order to produce 'open defecation-free' villages. The objective of the intervention is to reduce the incidence of diseases related to poor sanitation and manage public risks posed by the failure to safely confine the excreta of some community members. The way to achieve this objective is by empowering communities motivated to take collective action. Local governments and other agencies perform a facilitating role. There is a growing recognition that this approach, referred to as Community-Led Total Sanitation (CLTS), may help with the reduction of open defecation practices. However, no rigorous impact evaluation of CLTS has been conducted so far. This randomized controlled trial will study the effect of CLTS in rural Mali. As a result, sound evidence will become available to see to what extent CLTS improves health outcomes and what is driving collective action in order to increase sanitation coverage. The direct recipients of the intervention are members of rural communities in Mali who aspire to live in a cleaner environment. The donor community, international organizations, and governments in developing countries will benefit from having simple and clear evidence on the effectiveness of an innovative program for improving sanitation in rural areas. They will learn whether the program has worked or failed to achieve its objective of eradicating open defecation, and about key factors explaining success and failure.
Background: - Malaria is a disease that is spread by mosquitoes. Researchers are looking for a vaccine that can prevent mosquitoes from transmitting malaria to people. They want to test a vaccine called Pfs25-EPA/Alhydrogel that may help stop malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people vaccinated from getting sick with malaria. Researchers want to test this vaccine in people who live in rural Mali. To do so, the study will compare the symptoms and the blood tests of the participants who receive either the study vaccine or a regular hepatitis B/meningococcal vaccine. Objectives: - To see if Pfs25-EPA/Alhydrogel is a safe and effective malaria vaccine. Eligibility: - Healthy volunteers between 18 and 45 years of age who live in Bancoumana, Mali. Design: - Participants will be screened with a medical history, physical exam, and blood tests. - Participants will be separated into two groups. One group will have Pfs25-EPA/Alhydrogel to test the study vaccine. The other group will have the regular Hepatitis B vaccine series, meningococcal vaccine. - In the study vaccine group, participants will have either a lower dose or a higher dose. For the lower dose, they will have two vaccine shots over 1 year. For the higher dose, they will have four vaccine shots over about 14 months. - In the other vaccine group, participants will have the Hepatitis B vaccine series, meningococcal vaccine according to the standard dose schedule. - All participants will provide regular blood samples for testing during the study. - Participants who develop malaria during the study will participate in evaluation of transmission and parasite development of malaria parasite from the person to mosquito via transmission assays. They will allow mosquitoes (that have no diseases) to bite them in a controlled clinic setting. This will let researchers see if the vaccine can stop the mosquitoes from carrying malaria to other people.
This study will use longitudinal data collection to quantify the impact of a school-based water, sanitation and hygiene (WASH) program in Mali, West Africa, on pupil absenteeism, diarrheal illness, and respiratory illness. Data will be collected from 100 intervention and 100 control schools across 4 regions in Mali. At each school research staff will randomly select 60 pupils in grades 3-6 (typically ages 7-14). Research staff will ask school directors to provide written consent for pupil participation in place of parents, a procedure that has been approved by the Malian Ministry of Education. Research staff will approach selected pupils at school to request informed oral assent for participation. The informed assent process and data collection will be conducted by local trained enumerators in the child's preferred language of French or Bambara. Oral rather than written assent was chosen due to varied literacy capabilities and to limit paperwork that identifies participants. Data collection will take place at each school once every six to eight weeks during the duration of two school years. Research staff will conduct observations of school facilities, observations of handwashing behavior of children upon leaving latrines, and an interview with the school director about WASH conditions and school enrollment information. None of these school activities collect personal data or identifiers. Data collection with pupils will be done with the same pupils every 6-8 weeks and entails a 5-minute interview asking about recent absence and symptoms of diarrhea and respiratory illness. All data collection will occur at the school, will be conducted by trained local enumerators, and will be stored on password-protected mobile data collection devices. Data will be uploaded to a password-protected server and will not contain personal identifying information. Enumerators will maintain a separate form that links pupil IDs with names, which will be kept confidential. There are no direct benefits other than contribution to general knowledge that will inform future school WASH projects. There are no risks to participation other than a small amount of class time missed by pupils, and great efforts will be made to minimize time outside of class.
There is a large body of evidence from adult populations suggesting cognition in adults is affected by hydration status. The few studies conducted in the global North in populations of schoolchildren indicate that drinking water has an impact on pupil performance on basic cognitive tasks. No studies assessing the impact of dehydration and cognition in schoolchildren have been carried out in the global South, where access to water is the poorest and dehydration prevalence is likely higher. This study will examine the effect of drinking supplementary water during the school day on hydration status and on cognitive test scores in schoolchildren in Mali, West Africa. The investigators hypothesize that providing supplemental water will result in a decrease in prevalence of dehydration in the study group and will result in an improved performance on cognitive test scores. Data will be collected from up to four purposively-selected schools in the Sikasso region of Mali, from up to a total of 300 children. At each school pupils in grades 3-6 will be eligible for recruitment. Research staff will explain the study to pupils at the school and individually request informed oral assent for participation. A waiver of parental consent for pupil interviews will be secured from the Ministry of Education. At each school, school directors will be asked to sign in loco parentis ("in the place of parent") on behalf of the pupil participants. Children that assent to participate in the study will be randomly allocated to the intervention or control group. Data collection will take place at each school over two days within a one-week period, with one study group tested on each of the two days. On the intervention testing day, all study participants will receive supplementary water. On the control testing day, no study participants will receive supplementary water. Testing procedures in both groups is identical and will include a five-minute interview, two cognitive testing sessions of 45 minutes each, and collection of two urine samples during the day. None of these activities collect personal data or identifiers, and the urine sample will not be stored. All data collection will occur at the school and will be conducted by trained local enumerators. There are no risks to participation other than a small amount of class time missed by pupils, and great efforts will be made to minimize time outside of class.
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.