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

NCT07007585 | Recruiting

• 1 other identifier: CMX0003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dengue; Dengue Fever; Dengue Fever With Warning Signs

Keywords

Dengue; Hospitalization; Transfusion; Hemorrhagic Fever; Thrombocytopenia; Mexico

Outcome Measures

Primary Outcomes (2)

• 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: 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)

  Within 10 days of symptom onset

Secondary Outcomes (2)

• Proportion of patients receiving blood product transfusion

  Time Frame: Within 14 days

• Criteria for transfusion used by attending physicians

  Within 14 days of symptom onset

Other Outcomes (1)

• ICU admission or mortality

  Time Frame: 30 days

Study Arms (1)

Inpatient Confirmed Dengue Cohort

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.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients aged ≥5 years
• Laboratory-confirmed dengue infection (NS1, IgM, or PCR)
• First contact at emergency or outpatient services
• Informed consent signed by the patient or legal guardian

You may not qualify if:

• Co-infection with other arboviruses or COVID-19
• Pre-existing hematologic or oncologic disease
• Refusal to sign informed consent

Sponsors & Collaborators

• Jose Ivan Rodriguez de Molina Serrano: lead

Study Sites (1)

Clinica Mexico

Piedras Negras, Coahuila, 26000, Mexico

RECRUITING

Related Publications (1)

• Kalayanarooj S, Vaughn DW, Nimmannitya S, Green S, Suntayakorn S, Kunentrasai N, Viramitrachai W, Ratanachu-eke S, Kiatpolpoj S, Innis BL, Rothman AL, Nisalak A, Ennis FA. Early clinical and laboratory indicators of acute dengue illness. J Infect Dis. 1997 Aug;176(2):313-21. doi: 10.1086/514047.

  PMID: 9237695 BACKGROUND

MeSH Terms

Conditions

Dengue; Hemorrhagic Fevers, Viral; Thrombocytopenia

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Central Study Contacts

JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, MSc, Ph, Specialist

CONTACT

525525848735; jefe.urgencias@clinicamexico.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research and Medical Education Clinica Mexico

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 6, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

ME (1)