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Recruiting NCT07007585

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

Observational Dengue Dengue Fever Dengue Fever With Warning Signs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dengue, Dengue Fever, Dengue Fever With Warning Signs. Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection: A Prospective Observational Study

Overview

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.

Detailed description

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.

Primary outcome measures

  • Proportion of enrolled patients requiring hospitalization [Time frame: Time Frame: Within 10 days of symptom onset]
  • Clinical and laboratory risk factors associated with hospitalization [Time frame: Within 10 days of symptom onset]
Secondary outcome measures (2)
  • Proportion of patients receiving blood product transfusion [Time frame: Time Frame: Within 14 days]
  • Criteria for transfusion used by attending physicians [Time frame: Within 14 days of symptom onset]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Mexico · 1 center
  • Clinica Mexico — Piedras Negras

Publications

  • 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

Identifiers

NCT: NCT07007585 · CMX0003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗