An observational study in Dengue, Dengue Fever and Dengue Fever With Warning Signs, sponsored by Jose Ivan Rodriguez de Molina Serrano. Recruiting at 1 site in Mexico. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Jose Ivan Rodriguez de Molina Serrano · Observational
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.
This study will prospectively follow patients over 3 years to determine the relationship between clinical/laboratory variables and outcomes such as hospitalization and transfusion need. It seeks to improve understanding of real-world decision-making in transfusions for dengue-related thrombocytopenia and refine current hospitalization criteria based on locally observed predictors.
Patients will be enrolled consecutively at emergency departments or outpatient clinics with confirmed dengue infection. Clinical data (fever duration, bleeding signs, vomiting, abdominal pain, platelet count, hematocrit) and transfusion records will be collected and analyzed to identify independent predictors using multivariate logistic regression.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 100 is below the median of 595 across 80 observational studies indexed under Dengue.
Browse Dengue studies →Jose Ivan Rodriguez de Molina Serrano is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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The study population consists of patients with confirmed dengue virus infection who seek care at Clínica México, a second-level hospital located in Piedras Negras, Coahuila, Mexico. Participants will be enrolled from both the emergency department and outpatient services. The hospital primarily serves an urban and peri-urban population from northern Coahuila and bordering rural areas. This setting allows for the inclusion of a broad range of clinical presentations, from mild outpatient cases to severe dengue requiring hospitalization or intensive care.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes patients aged 5 years and older with laboratory-confirmed dengue virus infection (via NS1 antigen, IgM serology, or PCR) who present to the emergency department or outpatient clinic at Clínica México. Patients are prospectively followed from initial presentation through resolution of illness or hospital discharge. No interventions are administered as part of the study; standard clinical care is provided. Data collection focuses on identifying clinical and laboratory predictors of hospitalization and transfusion, including platelet count, hematocrit changes, bleeding signs, and warning symptoms. Transfusion decisions are made independently by the attending physicians, and their rationale is recorded for analysis.
Proportion of enrolled patients requiring hospitalization
The proportion of patients with laboratory-confirmed dengue infection who require hospitalization will be recorded. Hospitalization is defined as admission to the inpatient ward or intensive care unit for ≥24 hours due to dengue-related clinical indications. Unit of Measure: Percentage of participants (%)
Time frame: Time Frame: Within 10 days of symptom onset
Clinical and laboratory risk factors associated with hospitalization
Description: Among patients who are hospitalized, relevant clinical signs (e.g., persistent vomiting, mucosal bleeding, abdominal pain) and laboratory parameters (e.g., platelet count, hematocrit rise, leukopenia) will be analyzed to identify independent predictors for hospitalization using multivariate regression. Unit of Measure: Odds ratio for each factor (as determined by statistical modeling)
Time frame: Within 10 days of symptom onset
Proportion of patients receiving blood product transfusion
The proportion of participants who receive any blood product transfusion (platelets, red cells, plasma) will be documented. Transfusions must be indicated for dengue-related complications and recorded in the patient file. Unit of Measure: Percentage of participants (%)
Time frame: Time Frame: Within 14 days
Criteria for transfusion used by attending physicians
Documented clinical and laboratory criteria used to justify transfusion (e.g., platelet count \< 20,000/μL with bleeding, hemodynamic instability, or major hemorrhage) will be analyzed descriptively. No interventions will be assigned by the study team. Unit of Measure: Proportion of cases using each transfusion criterion (%)
Time frame: Within 14 days of symptom onset
ICU admission or mortality
Proportion of patients who require intensive care unit admission or who die during the course of illness will be recorded to characterize disease severity. Unit of Measure: Percentage of participants (%)
Time frame: Time Frame: 30 days
Plan to share: Undecided — Not yet decided.
Started Aug 2025 (actual). Primary completion is estimated for Jul 2028, 35 months after the start.
Of 36 observational studies under Dengue, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 71. This study's planned 35 months is below that.
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Jose Ivan Rodriguez de Molina Serrano