Respiratory Syncytial Virus InfectionsIRISNCT04925310
Infection With Respiratory Syncytial Virus in Infants
An observational study of Respiratory Syncytial Virus Infections and Respiratory Syncytial Virus (RSV), run by Hannover Medical School at 2 sites in Germany.
Trial summary
IRIS (Infection with RespIratory Syncytial Virus) is an observational, multi-center study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age below two years and hospitalization due to RSV infection at three German sites. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus-bronchiolitis
- How many people
- 350 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2013to 30 Oct 2023
- How long will I take part?
- 1 Month
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: The study enrolls hospitalized children with confirmed RSV infection between the first month of life and second year of life. The diagnosis of RSV is evaluated by point-of-care testing, and positive findings are confirmed by polymerase chain reac-tion (PCR). Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or car-diac diseases, and immunodeficiency.
Who may be able to join
- RSV Infection, confirmed by polymerase chain reaction (PCR)
- Need for hospitalisation
Who cannot join
- premature birth
- bronchopulmonary diseases
- cardiac diseases
- immunodeficiency
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Martin Wetzke, MD, 0049 511 532 3220, wetzke.martin@mh-hannover.de
Gesine Hansen, Prof, 0049 511 532 3220, hansen.gesine@mh-hannover.de
- Recruiting
Universitätsklinik für Kinder- und Jugendmedizin Oldenburg
Oldenburg, Lower Saxony, 26111
Jürgen Seidenberg, Prof, 0049 441 798 3540, seidenberg.juergen@klinikum-oldenburg.de
Mathias Lange, MD, 0049 441 798 3540, Lange.Matthias@klinikum-oldenburg.de
About this study
Official title: IRIS - Infection With Respiratory Syncytial Virus in Infants - a Prospective Observational Cohort Study
IRIS (Infection with RespIratory Syncytial Virus) is an observational, multi-center study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age below two years and hospitalization due to RSV infection at three German sites. Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or cardiac diseases, and immunodeficiency. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank. Detailed information on demographic characteristics and medical history is recorded, as well as comprehensive clinical data including vital signs, medication, and interventions.
Read the detailed description
The IRIS study is designed as a multicentric, prospective, observational study initiated at Hannover Medical School, Germany. Upon enrollment, detailed data on demographic background, case histo-ry, clinical presentation, physical examination, diagnostic findings, treatment, and other patient related items is collected. Data on disease course, treatment, and complications is gathered. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank (Hannover Unified Biobank). The study enrolls hospitalized children with confirmed RSV infection between the first month of life and second year of life. The diagnosis of RSV is evaluated by point-of-care testing (POCT, Sofia, Quidel, Kornwestheim, Germany), and positive findings are confirmed by polymerase chain reac-tion (PCR). Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or car-diac diseases, and immunodeficiency. Healthy control probands are enrolled via recruitment of patients undergoing routine surgical procedures. Written informed consent is obtained from all parents and caregivers. Three local study centers in northern Germany (Hannover, Oldenburg, and Hildesheim) are contributing. All study sites are secondary or tertiary care hospitals and undergo extensive training in recruitment, biosample acquisition and processing, data collection and data entry, logistics, and security.
- Conditions
- Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus-bronchiolitis
- Keywords
- Respiratory Syncytial Virus (RSV), Infants, bronchiolitis, infection, cohort study
- Medical subject headings
- Respiratory Syncytial Virus Infections, Bronchiolitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RSV Bronchiolitis Group | hospitalized children with confirmed RSV infection between the first month of life and second year of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe RSV infection
Number of patients with severe RSV infection in three tertiary care centers in northern Germany.
Measured: 5 years
Secondary outcomes (1)
Outcome meassures of severe RSV infection in children (composite endpoint)
- length of hospitalisation (days)
- length of additional oxygen supply (hours)
- number of patients with need for intensive care treatment
- number of patients with need for invasive ventilation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Oct 2013
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- 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
- 350 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hansen Gesine, Prof, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925310
- Sponsor's protocol ID
- MHH6309
- Acronym
- IRIS
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wetzke M, Funken D, Lange M, Bejo L, Haid S, Monteiro JGT, Schutz K, Happle C, Schulz TF, Seidenberg J, Pietschmann T, Hansen G. IRIS: Infection with RespIratory Syncytial Virus in infants-a prospective observational cohort study. BMC Pulm Med. 2022 Mar 15;22(1):88. doi: 10.1186/s12890-022-01842-1.
PubMed 35291998
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRIS - Infection With Respiratory Syncytial Virus in Infants - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04925310
- Acronym / sponsor ID
- IRIS / MHH6309
- Conditions
- Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus-bronchiolitis
- Keywords
- Respiratory Syncytial Virus (RSV), Infants, bronchiolitis, infection, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 14 Jun 2021 (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.
IRIS (Infection with RespIratory Syncytial Virus) is an observational, multi-center study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age below two years and hospitalization due to RSV infection at three German sites. Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or cardiac diseases, and immunodeficiency. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank. Detailed information on demographic characteristics and medical history is recorded, as well as comprehensive clinical data including vital signs, medication, and interventions.
Detailed description
The IRIS study is designed as a multicentric, prospective, observational study initiated at Hannover Medical School, Germany. Upon enrollment, detailed data on demographic background, case histo-ry, clinical presentation, physical examination, diagnostic findings, treatment, and other patient related items is collected. Data on disease course, treatment, and complications is gathered. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank (Hannover Unified Biobank). The study enrolls hospitalized children with confirmed RSV infection between the first month of life and second year of life. The diagnosis of RSV is evaluated by point-of-care testing (POCT, Sofia, Quidel, Kornwestheim, Germany), and positive findings are confirmed by polymerase chain reac-tion (PCR). Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or car-diac diseases, and immunodeficiency. Healthy control probands are enrolled via recruitment of patients undergoing routine surgical procedures. Written informed consent is obtained from all parents and caregivers. Three local study centers in northern Germany (Hannover, Oldenburg, and Hildesheim) are contributing. All study sites are secondary or tertiary care hospitals and undergo extensive training in recruitment, biosample acquisition and processing, data collection and data entry, logistics, and security.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSV Bronchiolitis Group | – | –hospitalized children with confirmed RSV infection between the first month of life and second year of life |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study enrolls hospitalized children with confirmed RSV infection between the first month of life and second year of life. The diagnosis of RSV is evaluated by point-of-care testing, and positive findings are confirmed by polymerase chain reac-tion (PCR). Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or car-diac diseases, and immunodeficiency.
Key inclusion criteria (2 listed)
- RSV Infection, confirmed by polymerase chain reaction (PCR)
- Need for hospitalisation
Key exclusion criteria (4 listed)
- premature birth
- bronchopulmonary diseases
- cardiac diseases
- immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of severe RSV infection
Time frame: 5 years
Number of patients with severe RSV infection in three tertiary care centers in northern Germany.
1 secondary outcome
Outcome meassures of severe RSV infection in children (composite endpoint)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Derived from this study: PubMed 35291998Wetzke M, Funken D, Lange M, Bejo L, Haid S, Monteiro JGT, Schutz K, Happle C, Schulz TF, Seidenberg J, Pietschmann T, Hansen G. IRIS: Infection with RespIratory Syncytial Virus in infants-a prospective observational cohort study. BMC Pulm Med. 2022 Mar 15;22(1):88. doi: 10.1186/s12890-022-01842-1.
- Individual participant dataSharing planned: Undecided
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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.
Hansen Gesine, Prof principal investigator
Hannover Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections and Respiratory Syncytial Virus (RSV), run by Hannover Medical School at 2 sites in Germany.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Wetzke, MD (0049 511 532 7436, wetzke.martin@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe RSV infection (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925310, which also lists 1 linked publication.
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 14 Jun 2021.