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Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus (IMAR)

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ClinicalTrials.gov Identifier: NCT03757429
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Swedish University of Agricultural Sciences
Information provided by (Responsible Party):
Robert Frithiof, Uppsala University

Brief Summary:

Infection with human respiratory syncytial (RS) virus is the most common cause of hospital stay due to pediatric lower respiratory tract infection. An exaggerated immune response contributes to the pathogenesis and small children may have over reactive airways for a long time after an infection.

New research has shown that polymorphonuclear leukocytes (PMNs) are stimulated by the virus. Besides fighting the infection they also cause collateral damage to the host. Among other mechanisms PMNs stimulates mucus formation that affects breathing. They also secrete enzymes, toxic proteins and free radicals that may cause harm to lung tissue and airways.

The current project strives towards identifying and quantifying inflammatory mediators in sputum, urine and blood of children with severe RS-virus infection. The ultimate aim of the project is to, in detail, describe proteins contributing to the pathogenesis of the disease.


Condition or disease Intervention/treatment
Respiratory Tract Infections Respiratory Syncytial Virus Infections Other: RS-virus infection

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : January 2022

Group/Cohort Intervention/treatment
RS-virus infection with mechanical ventilation
Patients admitted to the pediatric ICU with verified or suspected RS-virus infection that are mechanically ventilated.
Other: RS-virus infection
The intervention consists of lower respiratory tract infection due to RS-virus

Non-RS-virus infection with mechanical ventilation
Patients admitted to the pediatric ICU due to a cause other than a verified or suspected respiratory tract infection.
Other: RS-virus infection
The intervention consists of lower respiratory tract infection due to RS-virus




Primary Outcome Measures :
  1. Levels of inflammatory mediators in sputum [ Time Frame: Up to three weeks ]
    Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry

  2. Levels of inflammatory mediators in blood [ Time Frame: Up to three weeks ]
    Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry

  3. Levels of inflammatory mediators in urine [ Time Frame: Up to three weeks ]
    Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry


Secondary Outcome Measures :
  1. Disease severity as measured by sequential organ failure assessment score (SOFA-score) [ Time Frame: Up to 30-days ]
  2. Lung function as measured in respirator [ Time Frame: Up to 30-days ]
  3. Lung function as measured by spirometry [ Time Frame: Within 1 year ]
  4. Lung function as measured by spirometry [ Time Frame: Within 10 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children admitted to pediatric ICU
Criteria

Inclusion Criteria:

  • Admission to pediatric intensive care unit
  • Clinical need for invasive ventilation
  • Clinical need for intravascular catheterization
  • Clinical need for urine bladder catheterization
  • Patients with verified or suspected RS-virus-infection or no respiratory tract infection (control group)

Exclusion Criteria:

• Chronic inflammatory lung disease


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): NCT03757429


Locations
Sweden
Akademiska sjukhuset, Centraloperation Recruiting
Uppsala, Sweden, 75185
Contact: Robert Frithiof, MD PhD    0736563473    robert.frithiof@surgsci.uu.se   
Contact: Henrik Reinius, MD, PhD       henrik.olivero.reinius@akademiska.se   
Principal Investigator: Jean-Francois Valarcher, PhD         
Principal Investigator: Sara Hägglund, PhD         
Sponsors and Collaborators
Uppsala University
Swedish University of Agricultural Sciences

Responsible Party: Robert Frithiof, Principal Investigator, Uppsala University
ClinicalTrials.gov Identifier: NCT03757429     History of Changes
Other Study ID Numbers: 2017-515IMAR
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections