A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose

Status Completed

Clinical Trial Summary

Aim of study is to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of paediatric respiratory disease in the study's clinical setting compared to a Clinical Adjudication Committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for paediatric respiratory disease diagnosis in an emergency department. Eligible subjects/parents will be assented/consented, enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF).The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0diagnoses. Additional medical information will be collected from the treating team, from the subject/parent and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a CAC will determine the final clinical diagnosis for each enrolled subject using the disease case definitions, eCRF data, the subject's medical record and cough sound recordings.Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost and time of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed.The blinded ResAppDx v2.0diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0diagnoses compared to agreement with the CAC's final clinical diagnoses for this cohort.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06156436
Study type	Observational
Source	ResApp Health Limited
Contact
Status	Completed
Phase
Start date	January 1, 2024
Completion date	February 29, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Completed	`NCT05815264` - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above	Phase 1
Recruiting	`NCT04589936` - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care	N/A
Completed	`NCT02905383` - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital	N/A
Completed	`NCT06210737` - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years	Phase 4
Terminated	`NCT03944551` - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa	N/A
Terminated	`NCT04660084` - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Withdrawn	`NCT05702788` - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)	Phase 2
Not yet recruiting	`NCT04171674` - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.	N/A
Active, not recruiting	`NCT03140163` - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]	N/A
Completed	`NCT02638649` - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed	`NCT02864420` - Hospitalization at Home: The Acute Care Home Hospital Program for Adults	N/A
Recruiting	`NCT02515565` - Physiotherapy in Patients Hospitalized Due to Pneumonia.	N/A
Completed	`NCT02105298` - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)	N/A
Completed	`NCT01446926` - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants	Phase 1
Completed	`NCT01399723` - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia	Phase 3
Completed	`NCT01416519` - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation	N/A
Completed	`NCT01416506` - Community-Acquired Pneumonia (CAP) Surveillance	N/A
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms