NCT01550016

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
8 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

4.7 years

First QC Date

March 7, 2012

Last Update Submit

October 10, 2016

Conditions

Dengue Fever

Keywords

dengue warning signslatin americasouth east asiaother febrile illnessesdengue classification

Outcome Measures

Primary Outcomes (1)

  • Hospitalization or administration of IV fluid

    Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.

    14 days

Secondary Outcomes (1)

  • Development of severe disease

    14 days

Study Arms (1)

Febrile Patients

Observation of patients with possible dengue fever in the early phase of disease

Other: Observation

Interventions

ObservationOTHER

Clinical follow-up and laboratory investigations.

Febrile Patients

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Febrile patients presenting to outpatient clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

International Centre for Diarrhoeal Diseases

Dhaka, Dhaka Division, 1212, Bangladesh

Location

Fundacao Oswaldo Cruz (FIOCRUZ)

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Fundacao Universidade Estadual do Ceara

Fortaleza, Brazil

Location

Angkor Hospital for Children

Siem Reap, Cambodia

Location

Hospital National de Ninos Benjamin Bloom

San Salvador, El Salvador

Location

Gadjah Madah University

Yogyakarta, Indonesia

Location

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Universidad de Carabobo

Valencia, Valencia, Venezuela

Location

Oxford University Clinical Research Unit

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 26968374DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Dengue

Interventions

Observation

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Thomas Jänisch

    Heidelberg University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Study Start

October 1, 2011

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)BA(1)VN(1)CA(1)EL(1)MY(1)VE(1)BR(2)