Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Respiratory Infections in Children for Enhanced Diagnostics (TREND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233516
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
Stockholm South General Hospital
Science for Life Laboratory
Uppsala University
Astrid Lindgren Children´s Hospital
Sahlgrenska University Hospital, Sweden
Turku University Hospital
Information provided by (Responsible Party):
Tobias Alfvén, Karolinska Institutet

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.


Condition or disease
Community-acquired Pneumonia

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 419 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Trial of Respiratory Infections in Children for Enhanced Diagnostics
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
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).



Primary Outcome Measures :
  1. MxA - cases with viral and bacterial clinical CAP [ Time Frame: 2021 ]
    Clinically relevant difference in MxA-levels between cases with viral and bacterial clinical CAP

  2. Mxa viral clinical CAP and controls [ Time Frame: 2021 ]
    Clinically relevant difference in MxA-levels between cases with viral clinical CAP and controls

  3. PCR - respiratory pathogens in cases and controls [ Time Frame: 2020 ]
    Proportion of respiratory pathogens in cases and controls, using real time PCR

  4. Sensitivity and specificity - MariPOC [ Time Frame: 2021 ]
    Sensitivity and specificity for different respiratory viruses with MariPOC® Respi as compared to real-time PCR

  5. Sensitivity and specificity a novel PCR-based point-of-care test [ Time Frame: 2021 ]
    Sensitivity and specificity for different respiratory viruses with a novel PCR-based point-of-care test as compared to PCR

  6. Difference asthma prevalence and number of hospital-requiring respiratory infections - cases and controls, [ Time Frame: 2027 ]
    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


Secondary Outcome Measures :
  1. Specific assessment of MxA as a clinical biomarker [ Time Frame: 2021 ]
    Clinically relevant difference in MxA-levels comparing cases with viral clinical CAP with cases with atypical and mixed viral-bacterial clinical CAP as well as with controls with and without presence of respiratory viruses by PCR

  2. Specific assessment of MxA as a clinical biomarker [ Time Frame: 2021 ]
    Clinically relevant differences in MxA-levels in cases with regard to specific respiratory agents

  3. Specific assessment of MxA as a clinical biomarker [ Time Frame: 2021 ]
    Sensitivity and specificity for MxA in identifying viral clinical CAP

  4. Specific assessment of MxA as a clinical biomarker [ Time Frame: 2021 ]
    Sensitivity and specificity for identifying viral and bacterial infection respectively for CRP, PCT and combination test of CRP, PCT and MxA

  5. Assessment of PCT and CRP as clinical biomarkers [ Time Frame: 2021 ]
    Difference in CRP and PCT between children with viral, bacterial, atypical bacterial and mixed viral-bacterial infection

  6. Descriptive statistics of study cohort with regard to etiologic agent [ Time Frame: 2020 ]
    Differences in symptom, antibiotic treatment, acute complications, radiologic exams admission rate and length of stay between cases with viral, bacterial, atypical bacterial and mixed viral-bacterial infection

  7. Evaluation of MariPOC® Respi in a clinical setting [ Time Frame: 2022 ]
    Differences in symptom, antibiotic treatment, acute complications, radiologic exams admission rate and length of stay between cases who tested positive for respiratory virus by MariPOC® Respi as compared to those with a negative test

  8. Assessment of long-term outcomes of children with CAP [ Time Frame: 2027 ]
    Number of hospital-requiring respiratory infections in cases and controls

  9. Assessment of long-term outcomes of children with CAP [ Time Frame: 2027 ]
    Difference in asthma prevalence between cases with viral and bacterial clinical CAP as compared to an estimate of the prevalence in the general population

  10. Assessment of long-term outcomes of children with CAP [ Time Frame: 2027 ]
    Difference in proportion of hospital-requiring respiratory infections between cases with viral, bacterial, atypical and mixed viral-bacterial infection

  11. Evaluation of MariPOC® Respi [ Time Frame: 2022 ]
    Difference in MxA-levels between PCR+/MariPOC® Respi+ and PCR+/MariPOC® Respi- study subjects.

  12. Etiology of cases in TREND study [ Time Frame: 2020 ]
    Estimation of etiology of cases using two levels of certainty (definitive as well as probable definition).


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

Cases:

(all inclusion criteria to be met to be eligible for participation in the study).

  • 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:

(all inclusion criteria to be met to be eligible for participation in the study).

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233516


Locations
Layout table for location information
Sweden
Sachs' Children and Youth Hospital Recruiting
Stockholm, Sweden
Contact: Tobias Alfvén, Ass. Prof.    +46 8 6164118    tobias.alfven@ki.se   
Contact: Samuel Rhedin, MD-PhD    +46 70 518 66 51    samuel.rhedin@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Stockholm South General Hospital
Science for Life Laboratory
Uppsala University
Astrid Lindgren Children´s Hospital
Sahlgrenska University Hospital, Sweden
Turku University Hospital
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Tobias Alfvén, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03233516    
Other Study ID Numbers: 2017/958-31
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tobias Alfvén, Karolinska Institutet:
Community-acquired pneumonia
Pediatrics
Etiology
Point-of-care test
MxA
CRP
Procalcitonin
Infectious diseases
Respiratory viruses
Pediatric asthma
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Pneumonia
Infection
Lung Diseases
Respiratory Tract Diseases