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Dengue clinical trials

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NCT ID: NCT06268691 Completed - Dengue Clinical Trials

Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating

Start date: February 4, 2019
Phase: N/A
Study type: Interventional

Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain. The main questions it aims to answer are: Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia. Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti. The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA. The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm. In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined.

NCT ID: NCT06257810 Completed - Malaria Clinical Trials

Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the inappropriate use of antibiotics (discontinuation or non-initiation) and optimize the clinical management and prognosis of patients.

NCT ID: NCT06255509 Recruiting - Dengue Clinical Trials

Dengue Virus Infection Amongst Patients With Acute Febrile Illness

Start date: February 5, 2024
Phase:
Study type: Observational [Patient Registry]

A prospective observational study that will be conducted in Tangerang Regency, Indonesia with primary objective to determine the clinical characteristics, specific immune responses, and viral serotypes in patients with confirmed dengue virus infection in Tangerang District, Indonesia.

NCT ID: NCT06121934 Completed - Dengue Clinical Trials

Efficacy and Safety of Carica Papaya in Dengue Fever: A Randomised Clinical Trial

Start date: October 1, 2023
Phase: Phase 3
Study type: Interventional

This will be a placebo-controlled, multicenter-randomized prospective study of CPLE (Carica papaya leaf extract) tabs in dengue patients (WHO-Group A, B). The study will enroll 300 eligible dengue cases into two arms: one arm receiving CPLE 1000mg t.i.d for 5 days and the other group receiving a placebo. The main question to ask is whether CPLE reduces severe disease progression and increases platelet counts in dengue patients. The participant will be asked to take orally available CPLE capsules at a dose of 1000 mg (2 capsules, 500mg each) or identical placebo three times a day for 5 days

NCT ID: NCT06109532 Recruiting - Inflammation Clinical Trials

Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.

HINDIP
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

Prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

NCT ID: NCT06071481 Recruiting - Dengue Fever Clinical Trials

Role of Vitamin D in Prevention of Dengue Haemorrhagic Fever and Dengue Shock Syndrome

Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT06060067 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

Start date: April 4, 2024
Phase: Phase 3
Study type: Interventional

The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months. Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study. During the study, participants will visit their study clinic 6 times.

NCT ID: NCT06006559 Recruiting - Dengue Clinical Trials

A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

Start date: February 20, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.

NCT ID: NCT05967455 Active, not recruiting - Dengue Clinical Trials

Homologous Re-infection With Dengue 1 or Dengue 3

Start date: October 30, 2023
Phase: Phase 1
Study type: Interventional

Previous studies with one dengue infection in a controlled environment at Upstate generated data that has been important in understanding the clinical signs and symptoms and how a person's body reacts to dengue infection over time. This has helped investigators compare what is seen in the clinic to what is seen in areas where dengue is prevalent. The investigators want to collect similar information when a person gets the same dengue twice in a controlled environment with the hope that this will lead them to a better understanding of the disease. New participants - will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months; - will receive a second inoculation after 6 months and return to the clinic or be contacted by phone for three more months; - will collect saliva at home; - will allow the study team to collect blood and saliva at the clinic visits. Participants who have been in previous dengue inoculation studies at SUNY Upstate - will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months; - will collect saliva at home; - will allow the study team to collect blood and saliva at the clinic visits. All participants will be seen in the clinic every other day for the first three weeks after any inoculation.

NCT ID: NCT05938647 Recruiting - Severe Dengue Clinical Trials

Severe Dengue in Critical Care at Villavicencio, Colombia.

Start date: July 1, 2023
Phase:
Study type: Observational

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.