Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus

NCT03757429 | Completed

• 1 other identifier: 2017-515IMAR
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections; Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

RS-virus infection OTHER

The intervention consists of lower respiratory tract infection due to RS-virus

Non-RS-virus infection with mechanical ventilation; RS-virus infection with mechanical ventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Children admitted to pediatric ICU

You may qualify if:

• 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)

You may not qualify if:

• Chronic inflammatory lung disease

Sponsors & Collaborators

• Uppsala University: lead
• Swedish University of Agricultural Sciences: collaborator

Study Sites (1)

Akademiska sjukhuset, Centraloperation

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 29, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)