International Research Consortium on Dengue Risk Assessment, Management, and Surveillance (IDAMS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Dengue Fever |
Other: Observation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1) |
- Hospitalization or administration of IV fluid [ Time Frame: 14 days ] [ Designated as safety issue: No ]Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.
- Development of severe disease [ Time Frame: 14 days ] [ Designated as safety issue: No ]Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.
| Estimated Enrollment: | 10000 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Febrile Patients
Patients with possible dengue fever in the early phase of disease
|
Other: Observation
Clinical follow-up and laboratory investigations.
|
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| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Febrile patients presenting to outpatient clinic
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
Contacts and Locations| Contact: Thomas Jänisch | thomas.jaenisch@urz.uni-heidelberg.de |
| Brazil | |
| Fundacao Universidade Estadual do Ceara | Recruiting |
| Fortaleza, Brazil | |
| Contact: Andrea Caprara andreacaprara1@gmail.com | |
| Cambodia | |
| Angkor Hospital for Children | Recruiting |
| Siem Reap, Cambodia | |
| Contact: Varun Kumar varun@angkorhospital.org | |
| Contact: William Housworth | |
| El Salvador | |
| Hospital National de Ninos Benjamin Bloom | Recruiting |
| San Salvador, El Salvador | |
| Contact: Gabriela Maron gabrielamaron@yahoo.com | |
| Contact: Ernesto Pleites | |
| Indonesia | |
| Gadjah Madah University | Recruiting |
| Yogyakarta, Indonesia | |
| Contact: Ida Safitri-Laksono | |
| Contact ida_laksono@hotmail.com | |
| Malaysia | |
| University of Malaya Medical Centre | Recruiting |
| Kuala Lumpur, Malaysia | |
| Contact: Lucy Lum lumcs@ummc.edu.my | |
| Vietnam | |
| Oxford University Clinical Research Unit | Recruiting |
| Ho Chi Minh City, Vietnam | |
| Contact: Bridget Wills bwills@oucru.org | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Thomas Jaenisch, Principal Investigator, University of Heidelberg Medical Center |
| ClinicalTrials.gov Identifier: | NCT01550016 History of Changes |
| Other Study ID Numbers: | 281803 (EU FP7-HEALTH-2011) |
| Study First Received: | March 7, 2012 |
| Last Updated: | August 3, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Heidelberg Medical Center:
|
dengue warning signs latin america south east asia other febrile illnesses dengue classification |
Additional relevant MeSH terms:
|
Dengue Dengue Hemorrhagic Fever Arbovirus Infections Virus Diseases |
Flavivirus Infections Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral |
ClinicalTrials.gov processed this record on June 18, 2013