Dengue FeverIDAMSNCT01550016
International Research Consortium on Dengue Risk Assessment, Management, and Surveillance
An observational study of Dengue Fever, run by University of Heidelberg Medical Center at 9 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Dengue Fever
- What is being tested?
- Observation
- How many people
- 7,411 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Oct 2011to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Febrile patients presenting to outpatient clinic
Who may be able to join
- >= 5 years of age
- fever for less than 72 hours
Who cannot join
- presence of localizing signs suggestive of another diagnosis
- not likely to come back for daily follow-up
- complications or signs of severe disease
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
Brazil2 sites
Fundacao Universidade Estadual do Ceara
Fortaleza
Fundacao Oswaldo Cruz (FIOCRUZ)
Rio de Janeiro, Rio de Janeiro
Bangladesh1 site
International Centre for Diarrhoeal Diseases
Dhaka, Dhaka Division, 1212
About this study
Official title: Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)
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.
- Conditions
- Dengue Fever
- Being tested
- Observation
- Keywords
- dengue warning signs, latin america, south east asia, other febrile illnesses, dengue classification
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Clinical follow-up and laboratory investigations.
| Study group | Role | What they receive |
|---|---|---|
| Febrile Patients | Observation of patients with possible dengue fever in the early phase of disease Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization or administration of IV fluid
Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Heidelberg Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, University of Oxford
- Responsible party
- Principal investigator, Thomas Jaenisch, University of Heidelberg Medical Center
- Investigators
- Thomas Jänisch, Principal investigator, Heidelberg University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550016
- Sponsor's protocol ID
- 281803 (EU FP7-HEALTH-2011)
- Acronym
- IDAMS
- Status last verified
- Oct 2016
- First submitted
- 7 Mar 2012
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)
- ClinicalTrials.gov ID
- NCT01550016
- Acronym / sponsor ID
- IDAMS / 281803 (EU FP7-HEALTH-2011)
- Conditions
- Dengue Fever
- Keywords
- dengue warning signs, latin america, south east asia, other febrile illnesses, dengue classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,411 participants (actual)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Collaborators
- European Union, University of Oxford
- Study start
- Oct 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Febrile Patients | – | Other: ObservationObservation of patients with possible dengue fever in the early phase of disease |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Febrile patients presenting to outpatient clinic
Key inclusion criteria (2 listed)
- >= 5 years of age
- fever for less than 72 hours
Key exclusion criteria (3 listed)
- presence of localizing signs suggestive of another diagnosis
- not likely to come back for daily follow-up
- complications or signs of severe disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationClinical follow-up and laboratory investigations. | Other | Febrile Patients |
Primary outcome
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.
1 secondary outcome
Development of severe disease
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 26968374Jaenisch 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.
- IDAMS consortiumLink provided by the sponsor.
- Section Clinical Tropical Medicine, Heidelberg University Medical Center, GermanyLink provided by the sponsor.
- Oxford University Clinical Research Unit, Viet NamLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jänisch principal investigator
Heidelberg University Medical Center
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever, run by University of Heidelberg Medical Center at 9 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil, Bangladesh, Cambodia, El Salvador, Indonesia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization or administration of IV fluid (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.