NCT02381431

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

March 2, 2015

Last Update Submit

January 12, 2017

Conditions

Infections - BacterialPneumonia - Bacterial

Keywords

imagingdiagnosticpediatrics

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Secondary Outcomes (1)

  • diagnosis of additional site of infection possibly related to bacterial pneumonia

    within same hospital stay

Study Arms (1)

Thermal Imaging

EXPERIMENTAL

imaging using a thermal camera

Device: FLIR ONE

Interventions

FLIR ONEDEVICE
Thermal Imaging

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DAGA Memorial Hospital

Nagpur, Maharashtra, India

Location

MeSH Terms

Conditions

Bacterial InfectionsPneumonia, BacterialDisease

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patricia L Hibberd, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Global Health, MGHfC

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 6, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

IN(1)