Clinical trial NCT01550016: International Research Consortium on Dengue Risk Assessment, Management, and Surveillance
Official title: Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Fever
Keywords: dengue warning signs
latin america
south east asia
other febrile illnesses
dengue classification
Lead sponsor: University of Heidelberg Medical Center
Sponsor class: OTHER
Collaborators: name: European Union
name: University of Oxford
First posted: 2012-03-09
Enrollment: 7411
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: Febrile patients presenting to outpatient clinic

Brief summary: Improvements in diagnosis of dengue fever and prediction of which patients will get more severe disease are urgently needed to improve the treatment of patients with dengue. This is very important in places with many people who suffer from dengue but have limited health care resources. This study will enroll patients with fever which may be caused by dengue in 6 countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests and exams until they recover. Symptoms and laboratory tests will be followed so that the cause of fever can be determined. For patients who have dengue, the investigators will look for symptoms and tests which indicate more serious disease. This study will help to determine how to identify patients with dengue fever based on symptoms and simple laboratory tests and those who will get more serious disease. It will also help to define a more standardized management of patients with dengue fever.

Detailed description: Improvements in clinical diagnosis of dengue and risk prediction for severe disease are urgently needed to improve overall clinical care, especially in settings with a high case burden where appropriate allocation of limited resources is crucial to outcome. In this work package 10,000 outpatients with undifferentiated fever, consistent with possible dengue, will be recruited within 3 days of fever onset in 6 endemic countries (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam), and will be followed daily until full recovery. Clinical features and simple laboratory parameters differentiating dengue from other febrile illness will be identified, and, among those with confirmed dengue, risk factors for progression to more severe disease will be evaluated. As well as contributing to the development of diagnostic and prognostic algorithms the clinical cohort has considerable potential towards standardisation of procedures for dengue management and reporting.

Eligibility criteria: Inclusion Criteria:

* \>= 5 years of age
* fever for less than 72 hours

Exclusion Criteria:

* presence of localizing signs suggestive of another diagnosis
* not likely to come back for daily follow-up
* complications or signs of severe disease

Primary outcomes:
measure: Hospitalization or administration of IV fluid
timeFrame: 14 days
Secondary outcomes:
measure: Development of severe disease
timeFrame: 14 days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Diseases
city: Fortaleza
country: Brazil
facility: Fundacao Universidade Estadual do Ceara
city: Rio de Janeiro
country: Brazil
facility: Fundacao Oswaldo Cruz (FIOCRUZ)
city: Siem Reap
country: Cambodia
facility: Angkor Hospital for Children
city: San Salvador
country: El Salvador
facility: Hospital National de Ninos Benjamin Bloom
city: Yogyakarta
country: Indonesia
facility: Gadjah Madah University
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Valencia
country: Venezuela
facility: Universidad de Carabobo
city: Ho Chi Minh City
country: Vietnam
facility: Oxford University Clinical Research Unit
Study officials:
affiliation: Heidelberg University Medical Center
name: Thomas Jänisch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaenisch T, Tam DT, Kieu NT, Van Ngoc T, Nam NT, Van Kinh N, Yacoub S, Chanpheaktra N, Kumar V, See LL, Sathar J, Sandoval EP, Alfaro GM, Laksono IS, Mahendradhata Y, Sarker M, Ahmed F, Caprara A, Benevides BS, Marques ET, Magalhaes T, Brasil P, Netto M, Tami A, Bethencourt SE, Guzman M, Simmons C, Quyen NT, Merson L, Dung NT, Beck D, Wirths M, Wolbers M, Lam PK, Rosenberger K, Wills B. Clinical evaluation of dengue and identification of risk factors for severe disease: protocol for a multicentre study in 8 countries. BMC Infect Dis. 2016 Mar 11;16:120. doi: 10.1186/s12879-016-1440-3.