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International Research Consortium on Dengue Risk Assessment, Management, and Surveillance (IDAMS)

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ClinicalTrials.gov Identifier: NCT01550016
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : October 11, 2016
Sponsor:
Collaborators:
European Union
University of Oxford
Information provided by (Responsible Party):
Thomas Jaenisch, University of Heidelberg Medical Center

Tracking Information
First Submitted Date March 7, 2012
First Posted Date March 9, 2012
Last Update Posted Date October 11, 2016
Study Start Date October 2011
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2012)
Hospitalization or administration of IV fluid [ Time Frame: 14 days ]
Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01550016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 8, 2012)
Development of severe disease [ Time Frame: 14 days ]
Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Febrile patients presenting to outpatient clinic
Condition Dengue Fever
Intervention Other: Observation
Clinical follow-up and laboratory investigations.
Study Groups/Cohorts Febrile Patients
Observation of patients with possible dengue fever in the early phase of disease
Intervention: Other: Observation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2016)
7411
Original Estimated Enrollment
 (submitted: March 8, 2012)
10000
Actual Study Completion Date October 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bangladesh,   Brazil,   Cambodia,   El Salvador,   Indonesia,   Malaysia,   Venezuela,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT01550016
Other Study ID Numbers 281803 (EU FP7-HEALTH-2011)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Thomas Jaenisch, University of Heidelberg Medical Center
Study Sponsor University of Heidelberg Medical Center
Collaborators
  • European Union
  • University of Oxford
Investigators
Principal Investigator: Thomas Jänisch Heidelberg University Medical Center
PRS Account University of Heidelberg Medical Center
Verification Date October 2016