NCT02778672

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

May 16, 2016

Last Update Submit

September 5, 2017

Conditions

Keywords

bacterial pneumoniachildrendiagnosing pneumoniathermal imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Infants with potential pneumonia

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

Interventions

Infants with potential pneumonia

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

275 Infants at Queen Elizabeth Central Hospital in Blantyre, Malawi having a chest x-ray done to rule out pneumonia

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

MeSH Terms

Conditions

Pneumonia, BacterialBacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Patricia L Hibberd, MD, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair School of Public Health, Department of Global Health

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 20, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 8, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations