NCT03067558

Acute Respiratory Infection Diagnostic Aids (ARIDA) Controlled Accuracy Evaluation Protocol

Terminated Last updated 31 July 2017

What this trial tests

trial testing Children's automated respiratory rate monitor in Pneumonia Childhood in 150 participants. Terminated before completion.

Timeline

5 April 2017

Primary endpoint
22 May 2017

22 May 2017

Quick facts

Lead sponsor	Malaria Consortium
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	150
Start date	5 April 2017
Primary completion	22 May 2017
Estimated completion	22 May 2017
Sites	1 location across Ethiopia

Drugs / interventions tested

• Children's automated respiratory rate monitor
• MK2 Acute Respiratory Infection (ARI) Timer

Conditions studied

• Pneumonia Childhood — all drugs for Pneumonia Childhood →

Sponsor

Malaria Consortium

Who can join

Under 59 Months, any sex, with Pneumonia Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pneumonia is the leading infectious cause of death among children under 5 years of age globally. Many pneumonia deaths result from late care seeking and inappropriate treatment due to misdiagnosis of symptoms. The United Nations Children's Fund's (UNICEF's) Acute Respiratory Infection Diagnostic Aids (ARIDA) project aims to introduce automated respiratory rate (RR) counting aids for use by frontline health workers in resource limited community settings and health facilities. These RR counting aids aim to offer improved accuracy, effectiveness and acceptability compared to current practices for counting and classifying RR to detect fast breathing pneumonia.

The general aim of the controlled accuracy study is to understand whether the ARIDA test device accurately measures RR in children under 5 years of age with cough and/or difficult breathing. It is a cross-sectional, prospective study in a controlled setting comprising three types of device evaluations:

1. The accuracy of the ARIDA test device in measuring RR in young infants 0 to \<2months, children 2 to \<12 months and 12 to 59 months when compared to a video panel reference standard will be established through the first evaluation.
2. The consistency of the ARIDA test device will be established by determining the level of agreement between the measures of RR for two ARIDA test devices when used on the same child at the same time in those aged 2 to \<12 months and 12 to 59 months through the second evaluation.
3. A third evaluation on a different group of normal-breathing children aged 2 to 59 months will assess RR fluctuation over time due to ARIDA test device attachment.

Evaluations 1 and 2 for accuracy and consistency will also be undertaken with expert clinicians (EC) conducting a manual RR count to further the evidence base around the performance of current standard practice in a controlled setting.

The study is a cross-sectional, prospective study and will be conducted in paediatric in and outpatient departments Saint Paul's Hospital and Millennium Medical Collage in Addis Ababa, Ethiopia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Determining the Agreement Between an Automated Respiratory Rate Counter and a Reference Standard for Detecting Symptoms of Pneumonia in Children: Protocol for a Cross-Sectional Study in Ethiopia.
   Ward C, Baker K, Marks S, Getachew D, et al · · 2020 · cited 9× · PMID 32238340 · DOI 10.2196/16531