Trial of Respiratory Infections in Children for Enhanced Diagnostics

NCT03233516 | Completed

• 1 other identifier: 2017/958-31
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the TREND study is to improve the differential diagnosis of bacterial and viral etiology in children below 5 years of age with clinical community acquired pneumonia. Specific objectives:

• To assess the diagnostic accuracy of MxA for viral CAP (sub-study I)
• To study etiologies in children with CAP (sub-study II)
• To evaluate sensitivity and specificity for MariPOC® Respi test versus PCR for detection of respiratory viruses (sub-study III)
• To assess sensitivity and specificity for a novel RPA-based point-of-care test versus PCR for detection of respiratory viruses (sub-study IV)
• To assess long-term complications in children with CAP (sub-study V The study takes place at Sachs' Children and Youth hospital in Stockholm.

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired pneumonia; Pediatrics; Etiology; Point-of-care test; MxA; CRP; Procalcitonin; Infectious diseases; Respiratory viruses; Pediatric asthma

Outcome Measures

Primary Outcomes (6)

• MxA - cases with viral and bacterial clinical CAP

  Clinically relevant difference in MxA-levels between cases with viral and bacterial clinical CAP

  2021

• Mxa viral clinical CAP and controls

  Clinically relevant difference in MxA-levels between cases with viral clinical CAP and controls

  2021

• PCR - respiratory pathogens in cases and controls

  Proportion of respiratory pathogens in cases and controls, using real time PCR

  2020

• Sensitivity and specificity - MariPOC

  Sensitivity and specificity for different respiratory viruses with MariPOC® Respi as compared to real-time PCR

  2021

• Sensitivity and specificity a novel PCR-based point-of-care test

  Sensitivity and specificity for different respiratory viruses with a novel PCR-based point-of-care test as compared to PCR

  2021

• Difference asthma prevalence and number of hospital-requiring respiratory infections - cases and controls,

  Difference in asthma prevalence between cases and controls and difference in number of hospital-requiring respiratory infections between cases and controls after 3, 7 and 10 years

  2027

Secondary Outcomes (12)

• Specific assessment of MxA as a clinical biomarker

  2021

• Specific assessment of MxA as a clinical biomarker

  2021

• Specific assessment of MxA as a clinical biomarker

  2021

• Specific assessment of MxA as a clinical biomarker

  2021

• Assessment of PCT and CRP as clinical biomarkers

  2021

Study Arms (2)

Cases with clinical CAP

Children 1-59 months at Sachs' Children and Youth Hospital with clinical CAP (both severe and non-severe) according to WHO-criteria.

Control subjects

Children 1-59 months at Sachs' Children and Youth Hospital treated for a minor orthopedic (elective (e.g. hand surgery) or acute) or minor surgical disease, e.g. minor trauma (excluding e.g. appendicitis, major burns, major trauma).

Eligibility Criteria

• Age: 28 Days - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Case definition: Children 1-59 months at Sachs' Children and Youth Hospital with clinical CAP (both severe and non-severe) according to WHO-criteria Control definition: Children 1-59 months at Sachs' Children and Youth Hospital treated for a minor orthopedic (elective (e.g. hand surgery) or acute) or minor surgical disease, e.g. minor trauma (excluding e.g. appendicitis, major burns, major trauma). No matching will be performed but adjustments for age and season will be performed in the analyses.

You may qualify if:

• Cases:
• Age 28 days to 59 months
• Reported and/or observed breathing troubles OR cough
• Observed age-adjusted tachypnea (≥50 breaths/min in children 1-12 months, ≥40/min in children \>1year) OR chest in-drawings
• Written informed consent
• Controls:
• Age 28 days to 59 months
• Minor surgical or orthopedic disease (elective (e.g. hand surgery) or acute) or minor surgical disease, e.g. minor trauma (excluding e.g. appendicitis, major burns, major trauma)
• Written informed consent

You may not qualify if:

• Cases:
• Previously included as case in the study
• Hospitalized during last 14 days
• Controls:
• Symptoms of respiratory disease 7 days before enrollment
• Previously included as control in the study
• Hospitalized during last 14 days

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm South General Hospital: collaborator
• Science for Life Laboratory: collaborator
• Uppsala University: collaborator
• Astrid Lindgren Children´s Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Turku University Hospital: collaborator

Study Sites (1)

Sachs' Children and Youth Hospital

Stockholm, Sweden

Location

Related Publications (42)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

* capillary lithium-heparin tube (will be separated into two aliquots and diluted in a commercial buffer) * capillary point-of-care test CRP * nasopharyngeal swab for Mari-POC (diluted in 1.3ml MariPOC RTI buffer) * nasopharyngeal aspirate (diluted into 1.3ml saline) divided into three aliquots: 1. Real-time PCR-analysis of respiratory agents (400μl) 2. Frozen down at -80°C for study IV (400μl) 3. Available for routine microbiological testing as ordered by the attending physician. If not used, frozen down at -80°C for potential reanalyses. (500μl) All samples will be taken within 24h from arrival at the emergency unit and time for both blood and nasopharynx samples will be registered. It will also be noted if antibiotics have been given before samples taken.

MeSH Terms

Conditions

Community-Acquired Pneumonia; Communicable Diseases

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: November 20, 2017
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

SE (1)