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CompletedNCT01550016IDAMSUpdated Oct 11, 2016

International Research Consortium on Dengue Risk Assessment, Management, and Surveillance

An observational study in Dengue Fever, sponsored by University of Heidelberg Medical Center. Completed at 9 sites in 8 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2016-10-11.

Sponsored by University of Heidelberg Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,411
Ages
5 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dengue Fever

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Keywords

  • dengue warning signs
  • latin america
  • south east asia
  • other febrile illnesses
  • dengue classification
03

In context

Dengue

279 studies on the registry are indexed under Dengue; 45 are open to participants now.

This study's enrollment of 7,411 is above the median of 595 across 78 observational studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

University of Heidelberg Medical Center is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Febrile patients presenting to outpatient clinic

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,411 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Febrile Patients

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

    Other: Observation

Interventions

  • OtherObservation

    Clinical follow-up and laboratory investigations.

06

What researchers measure

Primary outcomes

  1. Hospitalization or administration of IV fluid

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

    Time frame: 14 days

Secondary outcomes

  1. Development of severe disease

    Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.

    Time frame: 14 days

07

Study locations

9 sites
  • International Centre for Diarrhoeal Diseases
    Dhaka, 1212, Bangladesh
  • Fundacao Universidade Estadual do Ceara
    Fortaleza, Brazil
  • Fundacao Oswaldo Cruz (FIOCRUZ)
    Rio de Janeiro, Brazil
  • Angkor Hospital for Children
    Siem Reap, Cambodia
  • Hospital National de Ninos Benjamin Bloom
    San Salvador, El Salvador
  • Gadjah Madah University
    Yogyakarta, Indonesia
  • University of Malaya Medical Centre
    Kuala Lumpur, Malaysia
  • Universidad de Carabobo
    Valencia, Venezuela
  • Oxford University Clinical Research Unit
    Ho Chi Minh City, Vietnam
08

References and documents

Publications

  • 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. PubMed 26968374 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01550016
Lead sponsor
University of Heidelberg Medical Center
Collaborators
European Union, University of Oxford
Responsible party
Thomas Jaenisch (Principal Investigator, University of Heidelberg Medical Center) — Principal investigator
First posted
Mar 9, 2012
Start date
Oct 2011
Primary completion
Jun 2016
Completion
Oct 2016
Last update
Oct 11, 2016

Study contacts

Thomas Jänisch
principal investigator · Heidelberg University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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