Extrait

Background and study aims Dengue is an infectious disease caused by four types of dengue virus, transmitted by mosquitoes. Dengue can be present with no symptoms at all or as a mild illness with fever, headache and joint aches, but can also be complicated by bleeding and shock. There is no treatment for dengue beyond supportive care and there is no vaccine. The World Health Organization lists dengue fever as one of the most important emerging infectious diseases in the world. Dengue viruses are highly variable: their genetic material changes slightly each time they replicate within their human or mosquito host. As a result, the millions of individual viruses within a host are all slightly different from each other. We call this the diversity of the virus. The goal of this study is to obtain dengue viruses from patients in hospital with dengue, from the mosquitoes in and around their house and from household members and neighbours that may be infected with or without being sick, and to test if the degree of diversity of the virus in different hosts is related to the severity of illness. The study will also look at the patients’ immune response in different degrees of dengue severity. Who can participate? This study aims to recruit dengue patients of all ages who have a high fever and test positive for dengue virus. This study will recruit between 18-110 dengue patients per year in Binh Thuan province. The actual number will depend on how many cases occur in the province. What does the study involve? When a dengue case is reported, study staff will take blood samples from the patient. They will take blood when the patient first arrives, and once per day until his/her fever is gone. These samples will be used for testing of the type of dengue virus, the number of viruses and their diversity, and of the patient’s immune response. Study staff will also draw blood from household members and neighbours of the patient. This study estimates there will be about 5-10 people who live close to the patient. Mosquito traps will be placed around houses with a dengue patient. A large black plastic container will also be used to collect mosquito larvae, pupae and eggs. These larvae will be bred and stored for future analysis. What are the possible benefits and risks of participating? Family members and neighbours will be tested for dengue by the study staff and referred to the community health station for clinical assessment and follow-up. Taking blood samples may cause mild discomfort and bruising. Where is the study run from? The study is run by researchers at the Oxford University Clinical Research Unit (OUCRU) – Viet Nam; Binh Thuan Medical College – Binh Thuan Province, Viet Nam; and the Academic Medical Center – Amsterdam, the Netherlands. When is the study starting and how long is it expected to run for? The study will run from July 2008 to October 2011 for a total of 3 years and 2 months. After enrolment of 16 index patients and 39 household contacts/neighbours, the study was stopped due to slow enrolment and problems with study staffing. Who is funding the study? The Wellcome Trust (UK). Who is the main contact? The Clinical Trials Unit at the Oxford University Clinical Research Unit – Viet Nam. +84839241983

Critère d'inclusion

• Dengue fever

Liens

• isrctn
• ictrp