Clinical Research Directory

Xpert® Tropical Fever Test on GeneXpert® Edge X System

This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.

International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)

Dengue fever, a viral infection transmitted by Aedes mosquitoes, is a major health issue in tropical and subtropical regions. Around 20-30% of symptomatic patients developed Dengue Hemorrhagic Fever (DHF), which leads to impaired hemostasis, subsequently increasing the risk of bleeding. The hemostatic abnormalities associated with dengue infection included vascular permeability, platelet dysfunction, and coagulation defects. Therefore, Individuals with underlying bleeding disorders are at increased risk of bleeding. Dengue infection in patients with hemophilia was reported, including six of 843 patients in the cohort with underlying hemophilia: five with hemophilia A and one with hemophilia B. Replacement therapy was more commonly used in patients with bleeding disorders and dengue than in patients with other febrile illnesses. All of them had bleeding during dengue infection. The mortality rate was high at 16%. Despite the importance of this issue, there is a lack of registries or data-collection systems to determine the bleeding complications, the requirement for replacement therapy, and the outcome of dengue infection in congenital bleeding disorders (CBDs). Therefore, this research aims to establish a registry of dengue infections among individuals with CBDs. The study is a multicenter, retrospective study from 1 January 2015 to 31 December 2025 and a prospective cohort study involving hospitals that treat individuals with CBDs and dengue. The registry format will be provided using REDCap system.

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV. Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times.

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

This 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. It also seeks to analyze real-world transfusion practices and their outcomes. The study will be conducted in a second-level hospital in northern Mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.

To Assess the Efficacy of Carica Papaya Leaf Extract in Improving Platelet Counts Among Pediatric Patients With Dengue-associated Thrombocytopenia

The goal of this clinical trial is to evaluate whether Carica papaya leaf extract (CPLE) can improve platelet counts in children aged 2 to 12 years diagnosed with dengue fever and thrombocytopenia. The main questions it aims to answer are: Does Carica papaya leaf extract significantly increase platelet counts compared to standard supportive therapy alone? Does the use of Carica papaya leaf extract reduce the need for platelet transfusion or PICU admission? Researchers will compare the group receiving CPLE plus standard therapy to the group receiving standard therapy alone to see if CPLE leads to improved platelet recovery and better clinical outcomes. Participants will: Be randomly assigned to receive either standard care or standard care plus Carica papaya leaf extract syrup (10 mL orally, three times daily for 3 days) Undergo blood testing on Day 1 and Day 3 to assess platelet count, hemoglobin, WBC, and packed cell volume Be monitored for clinical outcomes including need for transfusion and admission to the Pediatric Intensive Care Unit (PICU)

A Study in Children and Adolescents on the Effectiveness of Takeda's Licensed Dengue Vaccine TDV Against Hospitalization Due to Dengue Disease

The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries where TDV is already approved for use. The study will include cohort participants (individual follow-up of 3 years) who may or may not later be vaccinated with TDV as part of a pilot public vaccination program in the study countries. The study will investigate if cohort participants who were vaccinated with TDV have less hospital stays due to dengue than cohort participants who were not vaccinated with TDV. The study will also provide further information on the effectiveness of TDV against the least common dengue virus serotypes (DENV-3 and DENV-4).

Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)

The goal of this clinical trial is to understand if Resomelagon can treat adult patients with Dengue virus infection. The main questions the investigators aim to answer are: Is Resomelagon safe to use in patients with Dengue? Is Resomelagon able to reduce the duration of illness? (defined by clinical and laboratory criteria) Participants will be allocated to Resomelagon or placebo groups in this study and asked to take the medication and submitted to blood tests.

Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections

Exanthematous fevers are a global public health problem. The spread of arboviruses due to various factors, including climate change, has resulted in major epidemics such as the one that occurred in Brazil in 2024, representing an extremely concerning scenario from both epidemiological and healthcare perspectives. In addition to this, the reemergence of childhood exanthematous diseases in several countries, including Brazil, is alarming and occurs due to declining vaccination coverage and increased migratory movements. These diseases present overlapping clinical symptoms, and their differential diagnosis is often challenging, which, in a context of dengue and Chikungunya epidemics like the current one, may lead to underreporting of diseases such as measles and rubella. This project aims to build a prospective registry of the occurrence of dengue, Chikungunya, measles, and rubella in various healthcare centers in Brazil, in order to better understand the epidemiological scenario, identify clinical variables associated with different diagnoses, and describe healthcare bottlenecks that may hinder proper reporting and identification of these diseases.

Surveillance of Suspected Dengue Cases for Access to Care for Subjects Identified as Seronegative or Undetermined Before Receiving CYD Dengue Vaccine in Previous Clinical Studies in Colombia

The primary objective of the study is to identify any suspected dengue case in subjects that received at least one dose of the CYD dengue vaccine who were classified as seronegative or undetermined at baseline (according to PRNT50 at baseline, or anti-non-structural protein 1 \[NS1\] test Post-dose 3) in the Colombian study sites of CYD15, CYD13, CYD29, CYD64, CYD65 trials in order to allow appropriate access to care until the completion of 10 years after the last CYD Dengue Vaccine received by each participant

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

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.

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.

A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia

The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever. No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate.

Efficacy of Fresh Frozen Plasma (FFP) in Treating Thrombocytopenia in Dengue Patients

This clinical trial seeks to assess the effectiveness of fresh frozen plasma (FFP) in the treatment of thrombocytopenia in individuals with dengue. Dengue is a viral infection marked by thrombocytopenia, potentially resulting in significant hemorrhagic consequences. FFP is frequently utilized in the management of coagulopathies, and this study will investigate its efficacy in enhancing platelet count and mitigating bleeding risks in dengue patients with thrombocytopenia. The research will be executed as a randomized, controlled trial to evaluate outcomes in patients receiving routine care with and without FFP transfusion.