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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Respiratory Syncytial Virus Infections
• Intervention / Treatment: Other: RS-virus infection

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset, Centraloperation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children admitted to pediatric ICU

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of inflammatory mediators in sputum	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry	Up to three weeks
Levels of inflammatory mediators in blood	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry	Up to three weeks
Levels of inflammatory mediators in urine	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry	Up to three weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease severity as measured by sequential organ failure assessment score (SOFA-score)	Up to 30-days
Lung function as measured in respirator	Up to 30-days
Lung function as measured by spirometry	Within 1 year
Lung function as measured by spirometry	Within 10 years

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Swedish University of Agricultural Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): April 1, 2022
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Communicable Diseases; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 2017-515IMAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No