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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02778672
Other study ID # H-35690
Secondary ID OPP1140544
Status Completed
Phase N/A
First received May 16, 2016
Last updated September 5, 2017
Start date May 2016
Est. completion date June 2017

Study information

Verified date September 2017
Source Boston University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

Study Design


Intervention

Other:
Thermal imaging of infant's chest with a mobile phone


Locations

Country Name City State
Malawi Queen Elizabeth Central Hospital Blantyre

Sponsors (2)

Lead Sponsor Collaborator
Boston University Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of concordance between thermal image and the concurrent chest x-ray regarding the diagnosis of bacterial pneumonia Within 24 hours of the chest x-ray
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