Infections - BacterialNCT02908399
Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan
A study testing FLIR ONE in people with Infections - Bacterial and Pneumonia - Bacterial, run by Massachusetts General Hospital at 1 site in Pakistan.
Trial summary
This is a prospective study of up to 250 participants, from birth to 18 months, who have already had a chest x-ray while a patient at the National Institute of Health (NICH) in Karachi, Pakistan. Participants will include both males and females as well as all races and ethnicities. Read more about this study
- Who is it for?
- Ages Up to 18 months
- 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
- 250 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2016to Jun 2018
- 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 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 18 months or younger;
- patient at NICH Hospital in Karachi, Pakistan;
- had chest x-ray within last 24 hours to determine diagnosis of bacterial pneumonia;
- consent obtained from one parent
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
This is a prospective study of up to 250 participants, from birth to 18 months, who have already had a chest x-ray while a patient at the National Institute of Health (NICH) in Karachi, Pakistan. Participants will include both males and females as well as all races and ethnicities. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained radiologists to determine if bacterial pneumonia is present. Results of the thermal image will then be compared to the results of the chest x-ray. If additional images of the chest or other areas of suspected related infection are available, additional thermal images will be taken of the same location within 24 hours of the other image.
- Conditions
- Infections - Bacterial, Pneumonia - Bacterial
- Being tested
- FLIR ONE
- Medical subject headings
- Bacterial Infections, Pneumonia, Bacterial
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
Pneumonia is defined as the presence of an airspace opacity, lobar consolidation, or interstitial opacities on a chest x-ray. This determination will be made by two independent radiologists blinded to each other's readings, clinical information and thermal images. If they agree that pneumonia is either present or absent, that will be the final diagnosis. If there is disagreement, a third independent, blinded radiologist will break the tie.
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: up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2018 (estimated)
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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- 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
- NCT02908399
- Sponsor's protocol ID
- 2016P000898
- Status last verified
- Aug 2017
- First submitted
- 8 Sep 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan
- ClinicalTrials.gov ID
- NCT02908399
- Acronym / sponsor ID
- 2016P000898
- Conditions
- Infections - Bacterial, Pneumonia - Bacterial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Sep 2016 (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.
This is a prospective study of up to 250 participants, from birth to 18 months, who have already had a chest x-ray while a patient at the National Institute of Health (NICH) in Karachi, Pakistan. Participants will include both males and females as well as all races and ethnicities. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained radiologists to determine if bacterial pneumonia is present. Results of the thermal image will then be compared to the results of the chest x-ray. If additional images of the chest or other areas of suspected related infection are available, additional thermal images will be taken of the same location within 24 hours of the other image.
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 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 18 months or younger;
- patient at NICH Hospital in Karachi, Pakistan;
- had chest x-ray within last 24 hours to determine diagnosis of bacterial pneumonia;
- consent obtained from one parent
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
Pneumonia is defined as the presence of an airspace opacity, lobar consolidation, or interstitial opacities on a chest x-ray. This determination will be made by two independent radiologists blinded to each other's readings, clinical information and thermal images. If they agree that pneumonia is either present or absent, that will be the final diagnosis. If there is disagreement, a third independent, blinded radiologist will break the tie.
1 secondary outcome
diagnosis of additional site of infection possibly related to bacterial pneumonia
Time frame: up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- 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.
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 Pakistan.
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 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: status not confirmed, as of the sponsor's last update on 29 Aug 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 Pakistan. 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?
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?
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 29 Aug 2017.