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Completed

NCT Number: NCT03757429

Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Akademiska sjukhuset, Centraloperation

Uppsala, 75185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RS-virus infection

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Swedish University of Agricultural Sciences

Registry information

Acronym: IMAR

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2018
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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