Infectious MononucleosisNCT02463669
The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
An observational study of Infectious Mononucleosis and Splenomegaly, run by Jewish General Hospital at 2 sites in Canada.
Trial summary
The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department… Read more about this study
- Who is it for?
- Ages 10 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Mononucleosis, Splenomegaly
- What is being tested?
- Point-of-care ultrasound
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2016to 4 Oct 2020
- 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 10 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Convenience sample of patients between July 2016 and October 2017. Inclusion criteria are patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis.
Who may be able to join
- Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis
Who cannot join
- Chronic infectious disorders (eg. tuberculosis, malaria, HIV, syphilis)
- Inflammatory disorders (eg. sarcoidosis, amyloidosis, systemic lupus erythematosus, Felty syndrome)
- Proliferative disorders (eg. lymphoma, leukemia, essential thrombocytopenia, polycythemia vera)
- Congestive disorders (eg: cirrhosis, portal hypertension, right heart failure, congenital heart disease)
- Chronic haemolytic anemia (eg. sickle cell, thalassemia, hereditary spherocytosis)
- Storage diseases (eg. Gaucher, Niemann-Pick)
- Splenectomy
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CHU Sainte-Justine
Montreal, Quebec, H3T 1C4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).
Read the detailed description
The investigators seek to determine whether the presence of splenomegaly on POCUS can accurately diagnose acute infectious mononucleosis in symptomatic ED patients, and determine the feasibility of performing point-of-care ultrasound for splenomegaly by emergency physicians in the emergency department setting.
- Conditions
- Infectious Mononucleosis, Splenomegaly
- Being tested
- Point-of-care ultrasound
- Keywords
- Point-of-care ultrasound
- Medical subject headings
- Infectious Mononucleosis, Splenomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundDevice
Enrolled patients will undergo POCUS of the spleen by the treating emergency physician (resident, fellow or attending). Canadian Emergency Ultrasound Society (CEUS) certified residents, fellows and attending physicians will conduct the bedside ultrasonography after receiving specific training for the purposes of this study. The spleen will be assessed using a curved 2-6 Megahertz (MHz) transducer with the participant in the supine position. The cranio-caudal splenic length will be measured and its maximum dimension will be recorded on the standardized study data sheet.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound
Splenomegaly is defined as a splenic length of > 11.5 centimetres (cm) for 10-12 year-old patients, > 12 cm for 12-15 year-old patients, > 12 cm for 15-35 year-old female patients, and > 13 cm for 15-35 year-old male patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startApr 2016
- Primary completion4 Oct 2020
- Study completion4 Oct 2020
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious MononucleosisStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Robichaud, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463669
- Sponsor's protocol ID
- POCUSIM01
- Status last verified
- Oct 2020
- First submitted
- 31 May 2015
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
- ClinicalTrials.gov ID
- NCT02463669
- Acronym / sponsor ID
- POCUSIM01
- Conditions
- Infectious Mononucleosis, Splenomegaly
- Keywords
- Point-of-care ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID pandemic
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 4 Oct 2020 (actual)
- Study completion
- 4 Oct 2020 (actual)
- First posted
- 4 Jun 2015 (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.
The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).
Detailed description
The investigators seek to determine whether the presence of splenomegaly on POCUS can accurately diagnose acute infectious mononucleosis in symptomatic ED patients, and determine the feasibility of performing point-of-care ultrasound for splenomegaly by emergency physicians in the emergency department setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Convenience sample of patients between July 2016 and October 2017. Inclusion criteria are patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis.
Key inclusion criteria (1 listed)
- Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis
Key exclusion criteria (8 listed)
- Chronic infectious disorders (eg. tuberculosis, malaria, HIV, syphilis)
- Inflammatory disorders (eg. sarcoidosis, amyloidosis, systemic lupus erythematosus, Felty syndrome)
- Proliferative disorders (eg. lymphoma, leukemia, essential thrombocytopenia, polycythemia vera)
- Congestive disorders (eg: cirrhosis, portal hypertension, right heart failure, congenital heart disease)
- Chronic haemolytic anemia (eg. sickle cell, thalassemia, hereditary spherocytosis)
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 |
|---|---|---|
| Point-of-care ultrasoundEnrolled patients will undergo POCUS of the spleen by the treating emergency physician (resident, fellow or attending). Canadian Emergency Ultrasound Society (CEUS) certified residents, fellows and attending physicians will conduct the bedside ultrasonography after receiving specific training for the purposes of this study. The spleen will be assessed using a curved 2-6 Megahertz (MHz) transducer with the participant in the supine position. The cranio-caudal splenic length will be measured and its maximum dimension will be recorded on the standardized study data sheet. | Device | – |
Primary outcome
Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound
Time frame: 12 months
Splenomegaly is defined as a splenic length of > 11.5 centimetres (cm) for 10-12 year-old patients, > 12 cm for 12-15 year-old patients, > 12 cm for 15-35 year-old female patients, and > 13 cm for 15-35 year-old male patients.
Results and safety
The study was stopped early (reason given: COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Mononucleosis and Splenomegaly, run by Jewish General Hospital at 2 sites in Canada.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 was stopped early (reason given: COVID pandemic). Results are not available in the source record.
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?
Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound (time frame: 12 months). 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 6 Oct 2020.