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CompletedNCT03757429IMARUpdated May 31, 2022

Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus

An observational study in Respiratory Tract Infections and Respiratory Syncytial Virus Infections, sponsored by Uppsala University. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2022-05-31.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Tract Infections
  • Respiratory Syncytial Virus Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 31 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children admitted to pediatric ICU

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

Exclusion Criteria:

  • Chronic inflammatory lung disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherRS-virus infection

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

06

What researchers measure

Primary outcomes

  1. Levels of inflammatory mediators in sputum

    Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry

    Time frame: Up to three weeks

  2. Levels of inflammatory mediators in blood

    Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry

    Time frame: Up to three weeks

  3. Levels of inflammatory mediators in urine

    Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry

    Time frame: Up to three weeks

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

07

Study locations

1 site
  • Akademiska sjukhuset, Centraloperation
    Uppsala, 75185, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03757429
Lead sponsor
Uppsala University
Collaborators
Swedish University of Agricultural Sciences
Responsible party
Robert Frithiof (Principal Investigator, Uppsala University) — Principal investigator
First posted
Nov 29, 2018
Start date
Apr 1, 2018
Primary completion
Apr 1, 2022
Completion
Apr 1, 2022
Last update
May 31, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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