Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain
DengueTo evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. To this end, this first-in-human study will examine the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.
A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine...
DengueThe purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.
Pilot Study to Detect DENGUE Virus in Sperm
DengueThe purpose of this study is to seek the presence of dengue virus in semen, to determine its localization and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa. This is a prospective study involving 15 patients, with acute dengue virus infection and a positive RNA detection in blood or/and urines. These results are important to understand the physiopathology of dengue virus infection and will help to counsel the infected patient in epidemic zona or returning from epidemic country. Moreover, they will help to define the management and viral safety procedures during Medically assisted Procreation in the context of dengue virus epidemic
Implementation Research of New Dengue Vector Control Tools
DENGUEThis project will provide new insights concerning how to reduce dengue transmission by means of cost-effective and sustainable implementation strategies of vector control methods. The research will assess key strategies which deliver new vector control tools with respect to their cost-effectiveness, acceptability and sustainability in contrasting environments.
Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate...
Dengue FeverThe purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.
Ketotifen as a Treatment for Vascular Leakage During Dengue Fever
Dengue FeverPleural EffusionRationale and Aims: Infection by dengue virus (DENV) causes major morbidity and mortality throughout the world. In 2012, an estimated 3.6 billion people live in areas at risk for DENV infection, including Singapore. The key pathology of DENV infection is vascular leakage, which can occur in mild cases and can become life-threatening in severe cases when patients may develop dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS). Mast cells (MCs) are strongly activated by DENV with preliminary studies showing that activation levels are correlated to disease severity in human patients. Thus, the investigators propose to use the MC stabilizing drug, ketotifen, to limit the immune pathology that is characteristic of dengue infection and treat dengue-induced vascular leakage. Methods: The ability of Ketotifen to reduce vascular leakage in DENV patients will be determined by assessing the pooling of fluid in the pleural cavity (measured by MRI and CXR) after 5 days of drug administration, evaluated as a percent change compared to baseline fluid levels. Additional measures of vascular leakage and immune pathology will be compared as secondary objectives. The trial will be conducted as a randomized, double-blind study comparing the responses of dengue patients given either ketotifen or placebo (n=55 per arm). Importance of proposed research: Currently, no targeted treatments exist to limit vascular leakage during DENV infection. If Ketotifen is identified as effective for preventing pleural effusion and/or plasma leakage in DENV patients, this would constitute an advance for the clinical management of DENV fever. This finding would also support a large-scale trial to determine whether Ketotifen can be used to prevent severe vascular leakage as occurs during DHF/DSS. Benefits/Risks: Ketotifen has a record of safety and tolerability in humans, regulatory approval, and widespread use. Side effects are generally mild. The potential exists that, if effective, many of the painful and life-threatening symptoms of DENV infection that result from plasma leakage would be improved.
Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever
Dengue HemorrhagicEndothelial cell had important role in plasma leakage process. Plasma leakage occurs due to increased vascular permeability caused by disruption of endothelial glycocalyx showed by increased syndecan-1 level in serum. Endothelial vascular permeability disruption may cause several clinical manifestations such as increased haematocrit level, pleural effusion, ascites, hypoalbuminemia, thrombocytopenia, and bleeding manifestation. This condition will lead to hypoperfusion in the tissue and microvascular dysfunction. Microvascular dysfunction activated anaerob mechanism and resulting increased lactate level serum. Severe dysfunction can lead to shock and death if fluid resuscitation is inadequate in the first 24 hour. Fluid administration becomes key therapy for plasma leakage. Crystalloid is an isotonic fluid which can fill intravascular, however this fluid also quickly moved toward extravascular. Albumin 5% can help reduce the extravasation because of it can increase the osmotic pressure and maintaining the intravascular volume. In the first 24 hour after albumin administration, albumin is hypothesized can restore intravascular volume, repair and maintain glycocalyx, maintain vascular permeability, and restore microcirculation perfusion. This mechanisms can prevent worse outcome and hoped can reduce hospital stay. Many studies had been done regarding the choice of resuscitation fluid in septic patient. Until now, the role of albumin 5% as resuscitation fluid in DHF to prevent severe plasma leakage has not been studied.
Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms
Viral Haemorrhagic FeverDengue FeverTo meet eligibility criteria, this study and informed consent of the syndrome of fever associated with bleeding of infectious diseases, severe patients to carry out multicenter, practical randomized controlled clinical research, to compare the curative effect of western medicine, combining Chinese and western medicine treatment, and security, and pathogenesis of TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese medicine, Chinese medicine prescriptions mechanism research.
Effect of Hypertonic Sodium Lactate on sVCAM-1 Level as Surrogate Marker of Endothelial Capillary...
Dengue Shock SyndromeDengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) are among the leading causes of pediatric hospitalization in Asia.Mortality rates range from 1% at centres experienced in fluid resuscitation, to upto 44% in established shock.The mainstay of DSS treatment is prompt, vigorous fluid resuscitation with isotonic crystalloid solutions, followed by plasma or colloid solutions for profound or continuing shock. However, this administration is often associated with fluid overload and induces edema in these patients. Hence, we planned a parallel, randomized controlled trial comparing the efficacy and safety of solution containing half molar sodium lactate (Totilac™) with standard treatment(isotonic crystalloid Ringer's Lactate) in pediatric Dengue Shock Syndrome patients, using plasma soluble Vascular Cell Adhesion Molecule(sVCAM-1) levels as an indicator. Hypertonic solutions restore hemodynamic status rapidly with increased cardiac performance and improved tissue perfusion. This is obtained with much smaller volumes.We plan to assess the efficacy and safety of hypertonic sodium lactate in resuscitation of DHF/DSS patients.
Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Dengue Fever With Warning Signs
Dengue Fever With Warning SignsDengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action. This is a randomized control trial to determine the effectiveness of adjunctive melatonin therapy among patients diagnosed with Dengue fever with Warning Signs. This would include children aged 5 to 18 years old with no signs of hemmorhagic shock. They would be randomly assigned into 2 groups. Baseline Complete blood count with platelet (CBCPC) will be collected. Daily CBCPC will be collected and would be statistically analyze after the study.