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NCT ID: NCT02311387 Completed - Clinical trials for Lassa Virus Infection

Seroprevalence and Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali

Start date: December 5, 2014
Phase:
Study type: Observational

Background: - Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and droppings. When a group of researchers tested the mice in Soromba, Mali, they found that many were infected with Lassa fever. Lassa fever may also be passed through body fluids (like blood or semen) of people infected with Lassa fever. Researchers want to study this disease to help the government better protect the health of people in Sibirila. Objectives: - To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how many people get the disease every year. Eligibility: - People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no plans to relocate within 1 year. Design: - Households will be randomly selected to participate in the study. - Participants will have up to 20 drops of blood collected from the finger or heel. - Participants will be asked about their age. They will be asked if they have ever had a fever and if they have ever seen mice in or around their home. - Researchers will come back in 1 year and take another drop of blood from the participant. Participants will be asked the same questions. - If a participant has a fever at any time during the year, he or she should go to the health center. Researchers will collect a few drops of blood to test for Lassa fever. ...

NCT ID: NCT02286895 Completed - Diarrhea Rotavirus Clinical Trials

Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

Start date: October 2014
Phase: Phase 4
Study type: Interventional

This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.

NCT ID: NCT02267109 Completed - Ebola Virus Disease Clinical Trials

Phase 1 Trial of Ebola Vaccine in Mali

Start date: October 2014
Phase: Phase 1
Study type: Interventional

Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine.

NCT ID: NCT02211729 Completed - Malaria Clinical Trials

A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children

SMCAZ
Start date: May 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ. This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season. Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded. Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period Secondary endpoints: 1. incidence of the primary endpoint during the whole study period 2. attendance at a study health centre with a nonmalaria febrile illness 3. attendance at a study health centre with malaria, 4. the prevalence of moderate anaemia at the end of each malaria transmission season, 5. nutritional status at the end of each malaria transmission season, 6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season, 7. prevalence of resistance markers to SP at the end of the study, Sample size: 19,200 children (9600 in each country) will be enrolled.

NCT ID: NCT02206451 Completed - Malaria Clinical Trials

Assessing Human-to-Mosquito Transmission in Volunteers Participating in Malaria Vaccine Candidate Trials in Mali

Start date: July 16, 2014
Phase:
Study type: Observational

Background: - Malaria is a disease that affects many people in Mali and in Africa. It is caused by germs that are spread by mosquito bites. Researchers are creating vaccines that they hope will prevent malaria infection and/or the spread of it. Objective: - To test if the PfSPZ vaccine can stop malaria spread by mosquitoes. Eligibility: - People currently enrolled in the ongoing PfSPZ malaria vaccine trial. Participants must be willing to have uninfected mosquitoes bite them. Design: - Participants will be able to take part in this study at every visit after receiving all scheduled vaccinations. - Participants will be asked whether they are willing to participate in the procedures. Female participants will have a pregnancy test. - Researchers will put about 60 mosquitoes in 2 or 3 cups (20 or 30 in each cup). They will hold each cup to the participant s leg or arm so the mosquitoes can bite. These mosquitoes do not carry germs and will take about 3 drops of blood total. - Participants will get a cream for any swelling or itching. - Participants will be checked the next day for any discomfort. - Participants may take part in this feeding test multiple times, if they are willing. - If participants have malaria parasites in their blood, they may be asked to take part in another study. For this, they will sleep alone in their hut the night after the feeding test. A study team will set up nets to collect mosquitoes that may have bitten the participant overnight.

NCT ID: NCT02145377 Completed - Cholera Clinical Trials

PXVX0200 (CVD103-HgR) vs Shanchol in Mali

Start date: July 2014
Phase: Phase 2
Study type: Interventional

To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline. To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.

NCT ID: NCT02105714 Completed - Schistosomiasis Clinical Trials

Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders

NIDIAGDigest
Start date: July 2014
Phase: N/A
Study type: Observational

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

NCT ID: NCT01988636 Completed - Malaria Clinical Trials

Study of Safety and Effectiveness of Intravenous Immunization With PfSPZ Vaccine in Healthy African Adults

Start date: October 29, 2013
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT01958905 Completed - Malaria Clinical Trials

Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children

MAL-NUT
Start date: November 2013
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01955382 Completed - Malaria Clinical Trials

Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria

Start date: September 2013
Phase: Phase 2
Study type: Interventional

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.