International Research Consortium on Dengue Risk Assessme... | NCT01550016

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

NCT01550016

Sponsor

University of Heidelberg Medical Center

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

7,411Actual

Phase

Not provided

Conditions

Dengue Fever

Interventions

Observation

Countries

Bangladesh
Brazil
Cambodia
El Salvador
Indonesia
Malaysia
Venezuela
Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jun 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Mar 7, 2012

First Submission Date that Met QC Criteria

Mar 8, 2012

First Posted Date

Mar 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Jaenisch, Principal Investigator, University of Heidelberg Medical CenterPrincipal Investigator

Lead Sponsor

University of Heidelberg Medical CenterOTHER

Collaborators

Name	Class
European Union	OTHER
University of Oxford	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

7,411Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Febrile Patients		Observation of patients with possible dengue fever in the early phase of disease	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Clinical follow-up and laboratory investigations.	Febrile Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Febrile patients presenting to outpatient clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Jänisch	Heidelberg University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Centre for Diarrhoeal Diseases		Dhaka	Dhaka Division	1212	Bangladesh
Fundacao Oswaldo Cruz (FIOCRUZ)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26968374	Derived	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.

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

ID	Term
D008722	Methods
D008919	Investigative Techniques