DengueNCT03632486
Bedside Ultrasound Predicts Progression of Severity of Disease in Dengue Fever
An observational study of Dengue and Fever, run by Timothy Gleeson at 1 site in Cambodia.
Trial summary
The purpose of this study is determine the ability of bedside ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Read more about this study
- Who is it for?
- Ages Up to 16 years
- What is being tested?
- Bedside Ultrasound
- How many people
- 250 participants
- Where
- 1 siteCambodia
- Study dates
- 13 Aug 2018to 1 Oct 2019
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Study subjects will include children 16 years or less, who present during the annual dengue outbreak with suspected dengue fever. Subjects include children with fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test.
Who may be able to join
- Fever
- Clinical suspicion of non-severe dengue (with or without warning signs). (WHO 2010 guidelines)
- Not a prisoner or ward of the state
- Parents able and willing to give consent.
Who cannot join
- Allergic to US gel
- Known pleural or pericardial effusion
- Unstable vital signs
- Severe dengue
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is determine the ability of bedside ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the presence of gallbladder wall thickening, pulmonary edema/effusions, ascites, pericardial effusion in children correlates with progression to more severe disease.
Read the detailed description
Dengue fever has various levels of severity, from mild disease to severe hemorrhagic complications and shock. Dengue is endemic world-wide and has been found in the United States. The mortality from dengue fever can be as high as 15-20%, with nearly 22,000 deaths annually, most of them children (Reddy, 2013). There is no reliable way to immediately predict which children presenting with a fever during a Dengue fever outbreak will progress to more severe disease. Some children with dengue fever will improve with limited clinical interventions, but others require intensive therapy. Limited healthcare resources in developing countries make decisions on treatment or disposition difficult as many children and poor clinical decision increase morbidity and mortality. In more developed countries such as the United States, early identification of patients with dengue fever has the potential to identify children who may benefit from early interventions. Identifying those patients is the first step in exploring early therapies to effect mortality. Previous research has demonstrated that intrathoracic/ peritoneal fluid and gallbladder wall thickening is associated with more severe disease for hospitalized patients with dengue (Michels, 2013). The investigators will explore earlier presentations to the emergency department and outpatient department.
The study hypothesis is that the presence of early sonographic findings in children correlates with progression to more severe disease. The study specific aim is to determine the association between sonographic features of dengue and disease progression and clinical outcome in children with dengue fever.
This study is a prospective observational clinical study in the emergency department of the Angkor Hospital for Children in Siem Reap, Cambodia. Study subjects will include children 16 years or less, who present during a dengue outbreak with suspected dengue. Subjects include children with an acute febrile illness and criteria for dengue based on 2010 WHO guidelines (fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test). Clinicians will determine their clinical suspicion of dengue, intended therapeutic interventions and disposition following a history and physical exam. Study personnel will perform diagnostic bedside ultrasound imaging of the gallbladder, peritoneal, cardiac, and pleural spaces. Patients will be followed to determine clinical outcome, therapeutic interventions and disposition. The primary endpoint is progression of disease.
- Being tested
- Bedside Ultrasound
- Keywords
- Ultrasound, Dengue
- Medical subject headings
- Dengue, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside UltrasoundOther
Patients enrolled in this study will undergo bedside ultrasound during their initial presentation to the emergency department. Ultrasound imaging protocols include the following:
- FAST Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) sub-xyphoid 2)right upper quadrant (with right thorax) 3)left upper quadrant (with left thorax) and 4) suprapubic
- Right Upper Quadrant Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) Long axis of the gallbladder 2) Transverse axis of the gallbladder fundus 3) Transverse axis of the gallbladder body and 4) Transverse axis of the gallbladder neck.
- Lung ultrasound to assess for pleural effusions and sonographic b lines.
| Study group | Role | What they receive |
|---|---|---|
| Suspected Dengue | Children with fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test will all receive a diagnostic bedside ultrasound. Receives: Other: Bedside Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Progression of disease
Follow up of Patients to determine hospitalization or treatement
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start13 Aug 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Gleeson
- Sponsor type
- University, hospital or other
- Collaborators
- Angkor Hospital for Children
- Responsible party
- Sponsor-investigator, Timothy Gleeson, University of Massachusetts, Worcester
- Investigators
- Romolo Gaspari, MD PhD, Principal investigator, UMass Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632486
- Sponsor's protocol ID
- H00003325
- Status last verified
- Oct 2019
- First submitted
- 10 Jul 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasound Predicts Progression of Severity of Disease in Dengue Fever
- ClinicalTrials.gov ID
- NCT03632486
- Acronym / sponsor ID
- H00003325
- Keywords
- Ultrasound, Dengue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Timothy GleesonUniversity, hospital or other
- Collaborators
- Angkor Hospital for Children
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- 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.
The purpose of this study is determine the ability of bedside ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the presence of gallbladder wall thickening, pulmonary edema/effusions, ascites, pericardial effusion in children correlates with progression to more severe disease.
Detailed description
Dengue fever has various levels of severity, from mild disease to severe hemorrhagic complications and shock. Dengue is endemic world-wide and has been found in the United States. The mortality from dengue fever can be as high as 15-20%, with nearly 22,000 deaths annually, most of them children (Reddy, 2013). There is no reliable way to immediately predict which children presenting with a fever during a Dengue fever outbreak will progress to more severe disease. Some children with dengue fever will improve with limited clinical interventions, but others require intensive therapy. Limited healthcare resources in developing countries make decisions on treatment or disposition difficult as many children and poor clinical decision increase morbidity and mortality. In more developed countries such as the United States, early identification of patients with dengue fever has the potential to identify children who may benefit from early interventions. Identifying those patients is the first step in exploring early therapies to effect mortality. Previous research has demonstrated that intrathoracic/ peritoneal fluid and gallbladder wall thickening is associated with more severe disease for hospitalized patients with dengue (Michels, 2013). The investigators will explore earlier presentations to the emergency department and outpatient department.
The study hypothesis is that the presence of early sonographic findings in children correlates with progression to more severe disease. The study specific aim is to determine the association between sonographic features of dengue and disease progression and clinical outcome in children with dengue fever.
This study is a prospective observational clinical study in the emergency department of the Angkor Hospital for Children in Siem Reap, Cambodia. Study subjects will include children 16 years or less, who present during a dengue outbreak with suspected dengue. Subjects include children with an acute febrile illness and criteria for dengue based on 2010 WHO guidelines (fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test). Clinicians will determine their clinical suspicion of dengue, intended therapeutic interventions and disposition following a history and physical exam. Study personnel will perform diagnostic bedside ultrasound imaging of the gallbladder, peritoneal, cardiac, and pleural spaces. Patients will be followed to determine clinical outcome, therapeutic interventions and disposition. The primary endpoint is progression of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Dengue | – | Other: Bedside UltrasoundChildren with fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test will all receive a diagnostic bedside ultrasound. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study subjects will include children 16 years or less, who present during the annual dengue outbreak with suspected dengue fever. Subjects include children with fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test.
Key inclusion criteria (4 listed)
- Fever
- Clinical suspicion of non-severe dengue (with or without warning signs). (WHO 2010 guidelines)
- Not a prisoner or ward of the state
- Parents able and willing to give consent.
Key exclusion criteria (4 listed)
- Allergic to US gel
- Known pleural or pericardial effusion
- Unstable vital signs
- Severe dengue
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 |
|---|---|---|
| Bedside UltrasoundPatients enrolled in this study will undergo bedside ultrasound during their initial presentation to the emergency department. Ultrasound imaging protocols include the following: * FAST Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) sub-xyphoid 2)right upper quadrant (with right thorax) 3)left upper quadrant (with left thorax) and 4) suprapubic * Right Upper Quadrant Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) Long axis of the gallbladder 2) Transverse axis of the gallbladder fundus 3) Transverse axis of the gallbladder body and 4) Transverse axis of the gallbladder neck. * Lung ultrasound to assess for pleural effusions and sonographic b lines. | Other | Suspected Dengue |
Primary outcome
Clinical Progression of disease
Time frame: 10 days
Follow up of Patients to determine hospitalization or treatement
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 10 Oct 2019.
- 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.
Romolo Gaspari, MD PhD principal investigator
UMass Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Fever, run by Timothy Gleeson at 1 site in Cambodia.
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 4 inclusion and 4 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. 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?
Clinical Progression of disease (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2019.