Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan

Infections - Bacterial Clinical Trial

Official title:

Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02908399
• Other study ID #: 2016P000898
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 8, 2016
• Last updated: August 28, 2017
• Start date: October 2016
• Est. completion date: June 2018

Study information

• Verified date: August 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• thermal image cannot be done within 24 hours of chest x-ray

Related Conditions & MeSH terms

• Infections - Bacterial
• Pneumonia
• Pneumonia - Bacterial
• Pneumonia, Bacterial

Intervention

Device:
• FLIR ONE

Locations

Country	Name	City	State
Pakistan	National Institute of Child Health	Karachi

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	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	up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken