Extract

Background and study aims Patients with dengue can experience a variety of serious complications including shock, low blood platelets, and bleeding. Since these problems occur at a time when the virus is disappearing from the body, they are thought to caused partly by the body’s own natural defence mechanisms. Corticosteroids are a type of treatment that suppresses the natural defence mechanisms and therefore might prevent the development of such complications. However, it is also possible that this treatment could slow the clearance of the virus from the body, which might in turn cause more serious disease. Therefore, we performed this study – the first of its kind – to look at the safety of an early short course of oral prednisolone therapy (a kind of steroid) in patients with dengue. We investigated the effect of both low and high dose steroid treatments. Who can participate? Ethnic Vietnamese participants aged between 6 and 20 years and weighing at least 20 kg, who presented with a clinical diagnosis of dengue and fever for <=72 hours, but who had no signs of serious illness. What does the study involve? Suitable patients admitted to hospital within the first 3 days of fever were randomly allocated to receive either low or high dose oral prednisolone daily for 3 days, or a sham tablet containing no active drug. The treatments looked identical and none of the staff or patients involved knew which kind of treatment the participants received. All participants were reviewed daily until they had recovered fully, with careful documentation of a number of clinical factors and laboratory values related to their health and also to the level of virus in their body. They were then followed up several weeks after discharge to make sure that they had recovered fully. What are the possible benefits and risks of participating? Possible benefits included the fact that oral steroids might reduce the risk of developing the major complications of dengue described above. Adverse effects are rare in association with short courses of oral steroids given for other conditions such as asthma. Behaviour disturbance is occasionally reported among children receiving high doses but this usually improves when the drug is stopped. Other possible risks included the potential for making bleeding more severe than it might otherwise be, and for upsetting the regulation of blood sugar control and other systems related to the body’s metabolism. In addition, there might have been an increase in the amount or persistence of dengue virus in the body, due to suppression of the normal mechanisms that clear the virus during an infection. Where is the study run from? The study was conducted by researchers at the Oxford University Clinical Research Unit in Ho Chi Minh City, Viet Nam, in collaboration staff at the Hospital for Tropical Diseases of Ho Chi Minh City. When is the study starting and how long is it expected to run for? The study ran from August 2009 to January 2011. 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 +84 839241983

Inclusion criteria

• Dengue fever

Links

• isrctn
• ictrp