Active clinical trials for "Severe Dengue"

Dengue is an arthropod-borne disease, found in tropical and sub-tropical climates worldwide, mostly in urban and semi-urban areas. Unfortunately, there is no intervention available to stop dengue severity. Despite significant efforts into developing vaccine and antiviral drug for dengue fever over the years, numerous challenges remain before an efficient, safe vaccine and antiviral drug. Dengue Haemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS) are a serious form of dengue infection that can escalate in a non-negligible percentage of febrile patients. Factors responsible for this deterioration are weakly understood. The host's genetics and secondary infections from novel dengue serotypes are obvious risk factors. The dietary state of the host has also been emphasized as a potentially important predictor of progression because some nutrients have potent immunomodulatory effects. Vitamin D is particularly important as it has ability to control immunological processes, including the downregulation of pro-inflammatory Th1 activity, which has been linked to the pathophysiology of severe dengue. There is a preliminary study regarding the effectiveness of vitamin D in the prevention of DHF and DSS in human. But a larger study is needed to prove its utility. The objective of the study is to determine the role of Vitamin D in efficacy, safety and dose response in the prevention of DHF and DSS. This will be an open-label Phase-2 Randomized controlled trial (RCT) which will be carried out in Dengue cell, Emergency Department and Outpatient Department (OPD) of Medicine Department in Bangabandhu Sheikh Mujib Medical University, Dhaka. It will be conducted from September 2023 to August 2024 enrolling about 120 patients from Dengue cell, Emergency Department and OPD of Medicine Department BSMMU. The duration of the study will be one year. All the investigations will be done in BSMMU. Patients will be followed up by phone call and physical visit. Those with severe symptoms will be admitted and evaluated accordingly. The study will have three arms namely, Arm 1(receiving standard care), Arm 2(receiving standard care and 2,00,000 IU Vitamin D oral solution) and Arm 3(receiving standard treatment and 4,00,000 IU Vitamin D oral solution). The patients will be enrolled according to inclusion criteria (having age more than 18 to 65years, NS1 positive, fever more than ≥38°C for 3days or less, typical sign symptoms of Dengue fever) and exclusion criteria (>72hours of fever, critically ill patients, pregnancy, known Vitamin D hypersensitivity, high serum calcium level, hypoalbuminaemia, malignancy, known nephrolithiasis and severe renal impairment). Information will be obtained on socio-demographic and clinical characteristics through face to face interview using a structured questionnaire. Clinical data and relevant blood samples will be taken at first appointment then after 4th day and 8th day of enrollment. This study has minimal chance of physical risks. Study purpose will be explained to the participants and informed written consent will be taken before collection of data. Data will be collected with assurance of proper safety and privacy. The interventional drug, vitamin D3 is a widely used agent with rare minimal side effects like, vomiting, abdominal pain, headache, constipation etc. Each participant will be counselled about the outcome of the drug and will be followed up and managed for potential side effects. Participants will be identified by a code number, strict confidentiality and anonymity will be maintained. There will be no loss of work time and no compensation will be available for the participants as this will be a part of standard care. On the other hand, this study would be helpful for both the clinician and the patients in making a rational approach in Group A Dengue fever for the prevention of DHF and DSS. Prior to the commencement of this study, the research protocol will take approval from Research and Training Monitoring Department(RTMD) of BCPS. The analyzed data will be presented in the form of text, tables, and graphs. Finally collected data will be analyzed by graph pad prism. Statistical analysis will be performed by Chi-square test on categorical data and one way ANOVA with Tukey's multiple comparisons test on continuous data. Kaplan-Meier Curve will be used to study the progression into DHF and DSS. This study, for the first time in Bangladesh, will obtain the baseline data regarding the utility of Vitamin D therapy in Dengue uncomplicated cases in preventing further deterioration of clinical severity and mortality. This trial will help clinicians and policy makers to avail a possible repurposing of Vitamin D for prevention of severe dengue. In addition, it will guide designing larger study to generate strong evidence and change the national health response accordingly.

The goal of this randomized double-blinded placebo-controlled trial is to learn about dexamethasone and the treatment of severe dengue population. The main question it aims to answer are steroid therapy may be effective in dengue.

Severe dengue is a cause of admission to critical care, especially in pediatric cases, and during epidemic outbreaks. Fluid support is basically the therapy offered, due to a scarcity of antiviral or immunological options to modulate the disease. Dengue is an endemic condition in tropical and subtropical regions as Villavicencio, and local ICUs provide care to the adult and pediatric population from the city and distant surrounding areas. National and international agencies' clinical guidelines have standard recommendations for the therapy of dengue shock syndrome (DSS), but data about performance is not available. Severity, organ dysfunction, hemorrhagic events, and capillary leak are predictors for decease. There are several epidemiological trials about dengue in the region, although publications about the characteristics of patients in ICU are nearly null. Currently, there is enough human resources and technology in ICU to provide an optimal care in cases of severe dengue. There is a need to recognize most appropriate strategies for the treatment of the disease, and their results, to adjust and provide better outcomes. The aim of the study is to analyze the characteristics of patients with severe dengue admitted to the intensive care unit, to contribute to knowledge and better understanding of the disease in a specific clinical environment. An observational retrospective study will be designed by the analysis of the ICU database of hospitals from Villavicencio, Colombia, since January to May 2023. The records of patients admitted with a diagnose of severe dengue will be exported to Excel for reviewing and debugging. Demographic information, laboratory results, severity scores, and outcomes will be examined. Categorical variables will be described by frequency and proportion; quantitative variables will be defined in a central and dispersion distribution. Chi-square and Mann-Whitney U test will be used to compare, according to the characteristics of the outcome. It will be a pioneer study at this region, and it is necessary to determine the characteristics of patients admitted to the intensive care unit, the care provided, and the results of the treatment.

This study aims to evaluate the effect of anakinra in dengue patients with hyperinflammation as compared to placebo Primary Objective: To evaluate the efficacy of Anakinra in moderate-severe dengue patients with hyperinflammation. Secondary Objectives: To assess the safety of anakinra therapy in dengue with hyperinflammation To assess the effect of anakinra therapy in patients with dengue on physiological, clinical and virological parameters To assess the immunomodulation effects of anakinra in dengue Immune cell signatures in dengue with and without anakinra To assess difference in gene expression between treatment group compared to non-treatment population

To discribe concentration of NT-proBNP and Troponin I in Dengue hemorrhagic shock children, in correlation between concentration of NT-proBNP and troponin I with total fluid admission, respiratory support, using inotrope and vasopressor using.

The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting Primary Objective: To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs) occurring over a period of six (6) months after each Dengvaxia® dose administration; To quantify the association between Dengvaxia® and each of the selected AEs and SAEs for which a risk window after vaccination can be defined, using estimates of relative risk To monitor the occurrence and frequency of hospitalized dengue disease as well as any other SAEs leading to hospitalization or death, including new and previously unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years after the first Dengvaxia® dose administration. Secondary objectives: To identify risk factors for hospitalized dengue disease (severe or not) among subjects vaccinated with Dengvaxia®; To describe the frequency of hospitalized dengue disease and/or other SAEs or selected AEs according to the number of Dengvaxia® doses and/or interval between doses.

The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or sequentially. Primary Objectives: To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose. To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine. Secondary Objectives: To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine. To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group. To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group. To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.

This study aims to determine the efficacy of montelukast in reducing the incidence of dengue warning signs in adult dengue patients.

This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).

Design and Outcomes This research study is designed as open-label, sequential dose-escalating clinical trial. There will be two phases of enrollment. In the first phase, pediatric dengue patients with body weight greater than 30 kg will be recruited. The first six volunteers will be administered with 400 μg/kg every 24 hours for a total of three times. The last six volunteers will be administered with 600 μg/kg every 24 hours for a total of three times. In the second phase, pediatric dengue patients with body weight between 15 to 30 kg will be recruited. Similar to the first phase, the first six and the last six volunteers will be administered with 400 μg/kg and 600 μg/kg every 24 hours for a total of three times, respectively. A total of 24 volunteers will be recruited from Faculty of Medicine Siriraj hospitals