Respiratory Tract InfectionsIMARNCT03757429
Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus
An observational study of Respiratory Tract Infections and Respiratory Syncytial Virus Infections, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections, Respiratory Syncytial Virus Infections
- What is being tested?
- RS-virus infection
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2018to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children admitted to pediatric ICU
Who may be able to join
- 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)
Who cannot join
- Chronic inflammatory lung disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- RS-virus infection
- Medical subject headings
- Respiratory Tract Infections, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS-virus infectionOther
The intervention consists of lower respiratory tract infection due to RS-virus
| Study group | Role | What they receive |
|---|---|---|
| RS-virus infection with mechanical ventilation | Patients admitted to the pediatric ICU with verified or suspected RS-virus infection that are mechanically ventilated. Receives: 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. Receives: Other: RS-virus infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of inflammatory mediators in sputum
Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
Measured: Up to three weeks
Levels of inflammatory mediators in blood
Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
Measured: Up to three weeks
Levels of inflammatory mediators in urine
Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
Measured: Up to three weeks
Secondary outcomes (4)
Disease severity as measured by sequential organ failure assessment score (SOFA-score)
Measured: Up to 30-days
Lung function as measured in respirator
Measured: Up to 30-days
Lung function as measured by spirometry
Measured: Within 1 year
Lung function as measured by spirometry
Measured: Within 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish University of Agricultural Sciences
- Responsible party
- Principal investigator, Robert Frithiof, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757429
- Sponsor's protocol ID
- 2017-515IMAR
- Acronym
- IMAR
- Status last verified
- May 2022
- First submitted
- 22 Nov 2018
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus
- ClinicalTrials.gov ID
- NCT03757429
- Acronym / sponsor ID
- IMAR / 2017-515IMAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Swedish University of Agricultural Sciences
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RS-virus infection with mechanical ventilation | – | Other: RS-virus infectionPatients admitted to the pediatric ICU with verified or suspected RS-virus infection that are mechanically ventilated. |
| Non-RS-virus infection with mechanical ventilation | – | Other: RS-virus infectionPatients admitted to the pediatric ICU due to a cause other than a verified or suspected respiratory tract infection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children admitted to pediatric ICU
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Chronic inflammatory lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS-virus infectionThe intervention consists of lower respiratory tract infection due to RS-virus | Other | Non-RS-virus infection with mechanical ventilation, RS-virus infection with mechanical ventilation |
Primary outcome
Levels of inflammatory mediators in sputum
Time frame: Up to three weeks
Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
Levels of inflammatory mediators in blood
Time frame: Up to three weeks
Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
Levels of inflammatory mediators in urine
Time frame: Up to three weeks
Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
4 secondary outcomes
Disease severity as measured by sequential organ failure assessment score (SOFA-score)
Time frame: Up to 30-days
Lung function as measured in respirator
Time frame: Up to 30-days
Lung function as measured by spirometry
Time frame: Within 1 year
Lung function as measured by spirometry
Time frame: Within 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Respiratory Syncytial Virus Infections, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of inflammatory mediators in sputum (time frame: Up to three weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.