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Dengue clinical trials

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NCT ID: NCT04597437 Recruiting - Dengue Fever Clinical Trials

Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE)

ZAP-DENGUE
Start date: March 15, 2024
Phase: Early Phase 1
Study type: Interventional

ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of five days of intravenous zanamivir treatment to treat vascular permeability syndrome which is the main cause of death in dengue fever.

NCT ID: NCT04582474 Recruiting - Dengue Clinical Trials

Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response. The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive. An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease. In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.

NCT ID: NCT04514107 Recruiting - Dengue Fever Clinical Trials

A Cluster-randomized Trial to EValuate the Efficacy of Wolbachia-InfecTed Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil (EVITA Dengue)

Start date: September 9, 2020
Phase: Phase 2
Study type: Interventional

This is a cluster randomized controlled trial (CRCT) to evaluate the efficacy of Wolbachia-infected A. aegypti mosquito releases in reducing the burden of ARBV infection in Brazil over threefour years. The intervention will be the release of Wolbachia-infected A. aegypti mosquitoes. Standard control measures routinely established by the Belo Horizonte City Hall as recommended by the PNCD, will continue to be performed by the Belo Horizonte Health Department (Zoonoses Management) in all clusters, that is, the standard control measures will be carried out throughout the city of Belo Horizonte, independent of this clinical study. Wolbachia-infected A. aegypti will be deployed by releasing adult mosquitoes in pre-determined, thoroughly spaced release points in easily accessible roads described in a release map. A release map will be generated for each cluster and the numbers of release points will be determined by population density, surface area and mosquito abundance. Wolbachia-infected A. aegypti mosquitoes will be deployed across intervention clusters in two stages: 1) a 4 month establishment stage in which most of the releases will occur and 2) followed by an 8 month consolidation stage in which the abundance of Wolbachia-infected mosquitoes will be measured and remedial deployments will be completed, if needed, with the aim of achieving a high prevalence of Wolbachia amongst A. aegypti mosquitoes in intervention clusters within 12 months from the start of the release. The goal is to reach a Wolbachia prevalence of 60% or higher. Monitoring of Wolbachia prevalence in the cluster will continue throughout the study period, but no further mosquito deployments will occur after the consolidation stage is complete. The primary objective is to evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of ARBV infection compared to standard Aedes vector control measures alone.

NCT ID: NCT04478370 Recruiting - Malaria Clinical Trials

Characterizing Humoral Immune Response to Mosquito Bites

SG6
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

The characteristics of the humoral response directed against mosquito saliva antigens are not known precisely. This is a major limitation for using immunological markers as an outcome in epidemiological trials and as an indicator for operational deployment of interventions. Recent advances in the assembly of the genome of some Anopheles and Aedes mosquito vector species has facilitated the identification of new candidate peptides in silico, using the sequences of orthologous salivary gland proteins and B-cell prediction algorithms. The objective of this study is to assess the humoral immune response directed against candidate peptides following controlled exposure to laboratory-adapted colonies of An. minimus, An. maculatus and An. dirus, Ae. aegypti and Ae. albopictus. This research will provide essential information to identify and validate immunological markers of human exposure to malaria and dengue mosquito vectors in Southeast Asia. Immunological markers would be useful to understand transmission dynamics and predict the risk of transmission as part of a surveillance system, and to assess the efficacy of vector-control interventions in entomological trials or during operational deployment of interventions in the region.

NCT ID: NCT04422782 Recruiting - Children Clinical Trials

New Tools for Predicting Capillary Leak Shock During Dengue Fever

PrediDengue
Start date: May 14, 2020
Phase: N/A
Study type: Interventional

Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

NCT ID: NCT04076254 Recruiting - Dengue Hemorrhagic Clinical Trials

Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever

Start date: October 2016
Phase: Phase 3
Study type: Interventional

Endothelial 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.

NCT ID: NCT03799237 Recruiting - Dengue Clinical Trials

Combating Dengue With Innovative, Paradigm-shift-Strategies: Early Dengue Surveillance in Adult Aedes Mosquitoes

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

During dengue outbreaks, the Ministry of Health Malaysia employs various methods to control the spread of disease, including killing the larvae of Aedes mosquitoes, fogging, together with educating and disseminating information about the dengue outbreak, to the community. However, this is too late. Research has shown that when an outbreak has occurred, the viral infection has already spread among the community. Therefore, this current trial aims to educate the public (via questionnaire survey and interactions with the residential managements, mainly), detect dengue-infected mosquitoes, inform the communities of the presence of dengue-infected mosquitoes, followed by approaching and educating them to take precautionary measures before the outbreak happens. Trapping (using gravid oviposition sticky (GOS) traps) and detecting dengue virus non-structural 1 (NS1) antigen (using dengue NS1 kit) in the Aedes mosquitoes will be a more reliable way to alert the community before a potential dengue outbreak in their housing area. The community will receive information of presence of infected mosquitoes and probable dengue infections before dengue cases are reported. This will be an ideal time for clean-ups and for search and destroy activities. With this shift in approach and the use of newer techniques, it is hoped that deaths and epidemics due to dengue will be reduced.

NCT ID: NCT02673840 Recruiting - Pleural Effusion Clinical Trials

Ketotifen as a Treatment for Vascular Leakage During Dengue Fever

KETODEN
Start date: March 2015
Phase: Phase 4
Study type: Interventional

Rationale 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.

NCT ID: NCT02608047 Recruiting - Dengue Fever Clinical Trials

Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou

Start date: October 2014
Phase: N/A
Study type: Observational

The purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever.

NCT ID: NCT02606019 Recruiting - Dengue Clinical Trials

The Use of Biomarkers in Predicting Dengue Outcome

Start date: October 2015
Phase: N/A
Study type: Observational

The burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in differentiating severe dengue from non-severe dengue cases. The analysis between severe dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at the margin of the pre-determined p-value of less than 0.05. Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and liver function test (alanine aminotransferase and aspartate).