Clinical trial NCT07007585: Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection
Official title: Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dengue
Dengue Fever
Dengue Fever With Warning Signs
Keywords: Dengue
Hospitalization
Transfusion
Hemorrhagic Fever
Thrombocytopenia
Mexico
Lead sponsor: Clinica Mexico
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Proportion of enrolled patients requiring hospitalization
timeFrame: Time Frame: Within 10 days of symptom onset
measure: Clinical and laboratory risk factors associated with hospitalization
timeFrame: Within 10 days of symptom onset
Secondary outcomes:
measure: Proportion of patients receiving blood product transfusion
timeFrame: Time Frame: Within 14 days
measure: Criteria for transfusion used by attending physicians
timeFrame: Within 14 days of symptom onset
Other outcomes:
measure: ICU admission or mortality
timeFrame: Time Frame: 30 days
Locations:
city: Piedras Negras
country: Mexico
facility: Clinica Mexico
state: Coahuila
Study officials:
References:
citation: 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.