Pneumonia, BacterialNCT02778672
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
An observational study of Pneumonia, Bacterial and Infections, Bacterial, run by Boston University at 1 site in Malawi.
Trial summary
This is a study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Pneumonia, Bacterial, Infections, Bacterial
- What is being tested?
- Thermal imaging of infant's chest with a mobile phone
- How many people
- 273 participants
- Where
- 1 siteMalawi
- Study dates
- May 2016to Jun 2017
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Study population: 275 Infants at Queen Elizabeth Central Hospital in Blantyre, Malawi having a chest x-ray done to rule out pneumonia
Who may be able to join
- patient at Queen Elizabeth Central Hospital in Blantyre, Malawi
- having chest x-ray done to rule out pneumonia
- thermal image can be taken within 24 hours of chest x-ray
- parent/guardian provides written informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi. 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 study staff to determine if bacterial pneumonia is present. Results of the thermal images will then be compared to the results of the chest X-ray. If additional images of the chest are available, additional thermal images will be taken of the same location within 24 hours of the other image.
- Conditions
- Pneumonia, Bacterial, Infections, Bacterial
- Being tested
- Thermal imaging of infant's chest with a mobile phone
- Keywords
- bacterial pneumonia, children, diagnosing pneumonia, thermal imaging
- Medical subject headings
- Pneumonia, Bacterial, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imaging of infant's chest with a mobile phoneOther
| Study group | Role | What they receive |
|---|---|---|
| Infants with potential pneumonia | Not described Receives: Other: Thermal imaging of infant's chest with a mobile phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of concordance between thermal image and the concurrent chest x-ray regarding the diagnosis of bacterial pneumonia
Measured: Within 24 hours of the chest x-ray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Patricia Hibberd, Boston University
- Investigators
- Patricia L Hibberd, MD, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778672
- Sponsor's protocol ID
- H-35690
- Other IDs
- OPP1140544
- Status last verified
- Sep 2017
- First submitted
- 16 May 2016
- Last updated
- 8 Sep 2017
- 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 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
- ClinicalTrials.gov ID
- NCT02778672
- Acronym / sponsor ID
- H-35690
- Conditions
- Pneumonia, Bacterial, Infections, Bacterial
- Keywords
- bacterial pneumonia, children, diagnosing pneumonia, thermal imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- May 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 May 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 study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi. 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 study staff to determine if bacterial pneumonia is present. Results of the thermal images will then be compared to the results of the chest X-ray. If additional images of the chest are available, additional thermal images will be taken of the same location within 24 hours of the other image.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with potential pneumonia | – | Other: Thermal imaging of infant's chest with a mobile phone |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 275 Infants at Queen Elizabeth Central Hospital in Blantyre, Malawi having a chest x-ray done to rule out pneumonia
Key inclusion criteria (4 listed)
- patient at Queen Elizabeth Central Hospital in Blantyre, Malawi
- having chest x-ray done to rule out pneumonia
- thermal image can be taken within 24 hours of chest x-ray
- parent/guardian provides written informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Thermal imaging of infant's chest with a mobile phone | Other | Infants with potential pneumonia |
Primary outcome
Rate of concordance between thermal image and the concurrent chest x-ray regarding the diagnosis of bacterial pneumonia
Time frame: Within 24 hours of the chest x-ray
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 8 Sep 2017.
- 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.
Patricia L Hibberd, MD, PhD principal investigator
Boston University
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 Pneumonia, Bacterial and Infections, Bacterial, run by Boston University at 1 site in Malawi.
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: finished, as of the sponsor's last update on 8 Sep 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 Malawi. 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?
Rate of concordance between thermal image and the concurrent chest x-ray regarding the diagnosis of bacterial pneumonia (time frame: Within 24 hours of the chest x-ray). 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 8 Sep 2017.