Infections - BacterialNCT02381431
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India
A study testing FLIR ONE in people with Infections - Bacterial and Pneumonia - Bacterial, run by Massachusetts General Hospital at 1 site in India.
Trial summary
The purpose of this study is to see if thermal images can be used instead of a chest x-ray to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur, India. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections - Bacterial, Pneumonia - Bacterial
- What is being tested?
- FLIR ONE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2015to Jul 2016
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 18 years or younger
- patient at DAGA Memorial Hospital, Nagpur, India
- had chest x-ray within last 24 hours
- consent obtained from one parent
- assent obtained if child is 8 years or older
Who cannot join
- thermal image cannot be done within 24 hours of chest x-ray
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if thermal images can be used instead of a chest x-ray to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur, India. More specifically, the objectives of the study are: 1) to determine if thermal imaging, using a commercial thermal camera can accurately detect the presence of bacterial pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of infection that are suspected to be related to the pneumonia.
- Conditions
- Infections - Bacterial, Pneumonia - Bacterial
- Being tested
- FLIR ONE
- Keywords
- imaging, diagnostic, pediatrics
- Medical subject headings
- Bacterial Infections, Pneumonia, Bacterial, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIR ONEDevice
| Study group | Role | What they receive |
|---|---|---|
| Thermal Imaging | Experimental | imaging using a thermal camera Receives: Device: FLIR ONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of bacterial pneumonia
Thermal imaging will be used and compared to the chest x-ray taken within 24 hours to see if bacterial pneumonia is present
Measured: 24 hours
Secondary outcomes (1)
diagnosis of additional site of infection possibly related to bacterial pneumonia
Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician
Measured: within same hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections - BacterialStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lata Medical Research Foundation, Nagpur
- Responsible party
- Principal investigator, Patricia L. Hibberd, Massachusetts General Hospital
- Investigators
- Patricia L Hibberd, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381431
- Sponsor's protocol ID
- 2015P000265
- Status last verified
- Jan 2017
- First submitted
- 2 Mar 2015
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India
- ClinicalTrials.gov ID
- NCT02381431
- Acronym / sponsor ID
- 2015P000265
- Conditions
- Infections - Bacterial, Pneumonia - Bacterial
- Keywords
- imaging, diagnostic, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Lata Medical Research Foundation, Nagpur
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Mar 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 see if thermal images can be used instead of a chest x-ray to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur, India. More specifically, the objectives of the study are: 1) to determine if thermal imaging, using a commercial thermal camera can accurately detect the presence of bacterial pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of infection that are suspected to be related to the pneumonia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermal Imaging | Experimental | Device: FLIR ONEimaging using a thermal camera |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 18 years or younger
- patient at DAGA Memorial Hospital, Nagpur, India
- had chest x-ray within last 24 hours
- consent obtained from one parent
- assent obtained if child is 8 years or older
Key exclusion criteria (1 listed)
- thermal image cannot be done within 24 hours of chest x-ray
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 |
|---|---|---|
| FLIR ONE | Device | Thermal Imaging |
Primary outcome
diagnosis of bacterial pneumonia
Time frame: 24 hours
Thermal imaging will be used and compared to the chest x-ray taken within 24 hours to see if bacterial pneumonia is present
1 secondary outcome
diagnosis of additional site of infection possibly related to bacterial pneumonia
Time frame: within same hospital stay
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 16 Jan 2017.
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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.
Patricia L Hibberd, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLIR ONE in people with Infections - Bacterial and Pneumonia - Bacterial, run by Massachusetts General Hospital at 1 site in India.
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 5 inclusion and 1 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 16 Jan 2017. 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 India. 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?
diagnosis of bacterial pneumonia (time frame: 24 hours). 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 16 Jan 2017.