InfluenzaNCT01286285
Surveillance of Influenza in Paediatric Intensive Care Units in Bavaria
An observational study of Influenza and Acute Respiratory Infection, run by University Children's Hospital, Wuerzburg at 1 site in Germany.
Trial summary
The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units. Furthermore, the proportion of these children from all children hospitalized to paediatric intensive care units with acute respiratory infections will be established. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Influenza, Acute Respiratory Infection
- How many people
- 1,140 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Mar 2012
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ≤16 years of age, in hospitals with paediatric intensive care units or paediatric intensive care beds in Bavaria, Germany
Who may be able to join
- Male or female subjects, ≤16 years of age at the time of paediatric intensive care unit admittance. A subject will become ineligible on his/her 17th birthday
- All patients for whom a written Informed Consent Form for study participation can be obtained
- Children presenting with suspected acute respiratory infection of the upper or lower respiratory tract, with acute respiratory infection-related symptoms, e.g. sore throat (in children ≥ 3 years old), coryza (runny nose), cough etc. or B) Children already admitted to the paediatric intensive care unit without apparent acute respiratory infection/influenza-related symptoms that develop acute respiratory infection/influenza-related symptoms within the paediatric intensive care unit or
- Children admitted to the paediatric intensive care unit with suspected influenza (even without respiratory symptoms, e.g. with neurological symptoms) or
- Children admitted to the paediatric intensive care unit with potential influenza-triggered complications and laboratory-confirmed influenza ≤14 days before paediatric intensive care unit admission (by polymerase chain reaction or other influenza test methods)
- Additionally, all children with confirmed / suspected acute respiratory infection/ influenza that died already during admission to the paediatric hospital/ the paediatric intensive care unit will be included (a pseudonymous autopsy report including laboratory analyses (if available) will be requested for these patients).
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Active, Epidemiological Surveillance Study on Influenza-related Hospitalizations to Intensive Care Units and Fatalities in Paediatric Hospitals in Bavaria Covering the Influenza Seasons 2010/2011 and 2011/2012
The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units. Furthermore, the proportion of these children from all children hospitalized to paediatric intensive care units with acute respiratory infections will be established.
Read the detailed description
Accurate epidemiological data on severe influenza-associated hospitalizations and fatalities in children are lacking in Germany. The purpose of this study is primarily, to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units due to suspected acute respiratory infections/ influenza/ influenza-triggered complications and in children developing influenza during paediatric intensive care unit hospitalization, as well as the number of influenza-associated fatalities. In addition we aim at assessing clinical features, severity, risk factors, complications, diagnostic procedures, treatment and outcome of severe, laboratory-confirmed influenza (and other acute respiratory infections) in these children. Another objective is to estimate the proportion of laboratory-confirmed influenza cases in all children hospitalized to paediatric intensive care units with acute respiratory infections and to evaluate the number and proportion of paediatric intensive care unit hospitalizations due to other viral acute respiratory infections. Additional aims are to estimate the (minimum) incidence of severe influenza-associated hospitalizations in Bavarian children and to estimate the (minimum) incidences of other acute respiratory infections.
Ideally, this study will be conducted between October 2010 and March 2012 in all Bavarian (Germany) hospitals with paediatric intensive care units or paediatric intensive care beds (neonatology excluded). To optimize reporting there will be one study physician at each site responsible for documentation, diagnostic procedures and queries. The local study physician will receive an initiation visit at the start of each season, and will be contacted by the study coordination (situated at the University Children's Hospital in Wuerzburg) bi-weekly by phone. This local study physician summarizes the paediatric intensive care unit admittance in a log sheet, documents epidemiological, demographical, and clinical data in a questionnaire for all suspected acute respiratory infections/influenza patients with parental informed consent (pseudonymous data only), and draws a nasopharyngeal swab or -wash if indicated as routine procedure. A sample will be sent to the central laboratory (Institute for Virology and Immunobiology, University of Wuerzburg) for analysis (influenza-polymerase chain reaction, influenza virus subtyping, other viral acute respiratory infections (respiratory syncytial virus, parainfluenza 1-4, humane metapneumovirus, adenoviruses, rhinoviruses, enteroviruses). The central laboratory will analyse the samples timely and report the results to the respective study site. Additional influenza-tests may also be performed by the local laboratory, at the discretion of the hospitals. All tests, locally and performed in Wuerzburg, and their outcome should be reported in the questionnaire.
- Conditions
- Influenza, Acute Respiratory Infection
- Keywords
- influenza, acute respiratory infections, paediatric, intensive care units, epidemiology
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
number and proportion of influenza-/ acute respiratory infection-associated hospitalizations to paediatric intensive care units
- To evaluate the number of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in children ≤16 years of age
- To evaluate the proportion of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in all children ≤16 years of age hospitalized to paediatric intensive care units with acute respiratory infections or suspected influenza
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
Secondary outcomes (7)
health status at discharge
- To evaluate the health status at discharge (outcome: alive without sequelae, alive with sequelae, deceased) in children ≤16 years of age hospitalized to paediatric intensive care units with laboratory-confirmed influenza (seasonal and new influenza A (H1N1))
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
severity of disease
- To evaluate the severity of disease in children ≤16 years of age hospitalized to paediatric intensive care units with laboratory-confirmed influenza (seasonal and new influenza A (H1N1))
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
symptoms and complications
- To evaluate the number of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) cases treated with mechanical ventilation in children ≤16 years of age hospitalized to paediatric intensive care units
- To evaluate symptoms, complications, risk factors, and therapeutic procedures in children ≤16 years of age hospitalized to paediatric intensive care units with laboratory-confirmed influenza (seasonal and new influenza A (H1N1))
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
comparison between influenza A and B as well as seasonal and new influenza
- To compare age distribution, symptoms, complications, severity, risk factors, therapeutic procedures and outcome (fatalities, sequelae) between seasonal influenza A (and subtypes) and influenza B (and lineages) in children ≤16 years of age hospitalized to paediatric intensive care units
- To compare age distribution, symptoms, complications, severity, risk factors, therapeutic procedures and outcome (fatalities, sequelae) between seasonal influenza and new influenza A (H1N1) in children ≤16 years of age hospitalized to paediatric intensive care units
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
comparison of different influenza tests
- To evaluate the positive rate of other microbiological influenza tests than polymerase chain reaction (rapid test, immunoflourescence etc, if locally performed by hospitals/laboratories) in children ≤16 years of age hospitalized to paediatric intensive care units
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
number of acute respiratory infection-associated hospitalizations to paediatric intensive care units, comparison with influenza-associated hospitalizations to paediatric intensive care units
- To evaluate the number and proportion of hospitalizations to paediatric intensive care units admitted due to other acute respiratory infections in children ≤16 years of age
- To compare age distribution, symptoms, complications, severity, risk factors, therapeutic procedures, and outcome (fatalities/sequelae) between children hospitalized to paediatric intensive care units with influenza and children hospitalized to paediatric intensive care units due to other acute respiratory infections
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
number of hospitalizations related to the corresponding population
- To estimate the (minimum) incidence of laboratory-confirmed influenza (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in Bavaria in children ≤16 years of age
- To estimate the (minimum) incidence of laboratory-confirmed hospitalizations to paediatric intensive care units in Bavaria in children ≤16 years of age due to other acute respiratory infections
Measured: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startOct 2010
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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
- Time perspective
- Prospective
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Wuerzburg
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, University of Wuerzburg
- Investigators
- Johannes G. Liese, MD, MSc, Principal investigator, University Children's Hospital Wuerzburg, Paediatric Infectiology and Immunology, Josef-Schneider-Str. 2, 97080 Wuerzburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286285
- Sponsor's protocol ID
- UNIV HOSP WUERZBURG 7106877
- Status last verified
- Jan 2011
- First submitted
- 19 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Milne BG, Williams S, May ML, Kesson AM, Gillis J, Burgess MA. Influenza A associated morbidity and mortality in a Paediatric Intensive Care Unit. Commun Dis Intell Q Rep. 2004;28(4):504-9. doi: 10.33321/cdi.2004.28.58.
PubMed 15745400Poehling KA, Edwards KM, Weinberg GA, Szilagyi P, Staat MA, Iwane MK, Bridges CB, Grijalva CG, Zhu Y, Bernstein DI, Herrera G, Erdman D, Hall CB, Seither R, Griffin MR; New Vaccine Surveillance Network. The underrecognized burden of influenza in young children. N Engl J Med. 2006 Jul 6;355(1):31-40. doi: 10.1056/NEJMoa054869.
PubMed 16822994Rojo JC, Ruiz-Contreras J, Fernandez MB, Marin MA, Folgueira L. Influenza-related hospitalizations in children younger than three years of age. Pediatr Infect Dis J. 2006 Jul;25(7):596-601. doi: 10.1097/01.inf.0000220208.59965.95.
PubMed 16804428Finelli L, Fiore A, Dhara R, Brammer L, Shay DK, Kamimoto L, Fry A, Hageman J, Gorwitz R, Bresee J, Uyeki T. Influenza-associated pediatric mortality in the United States: increase of Staphylococcus aureus coinfection. Pediatrics. 2008 Oct;122(4):805-11. doi: 10.1542/peds.2008-1336.
PubMed 18829805Libster R, Bugna J, Coviello S, Hijano DR, Dunaiewsky M, Reynoso N, Cavalieri ML, Guglielmo MC, Areso MS, Gilligan T, Santucho F, Cabral G, Gregorio GL, Moreno R, Lutz MI, Panigasi AL, Saligari L, Caballero MT, Egues Almeida RM, Gutierrez Meyer ME, Neder MD, Davenport MC, Del Valle MP, Santidrian VS, Mosca G, Garcia Dominguez M, Alvarez L, Landa P, Pota A, Bolonati N, Dalamon R, Sanchez Mercol VI, Espinoza M, Peuchot JC, Karolinski A, Bruno M, Borsa A, Ferrero F, Bonina A, Ramonet M, Albano LC, Luedicke N, Alterman E, Savy V, Baumeister E, Chappell JD, Edwards KM, Melendi GA, Polack FP. Pediatric hospitalizations associated with 2009 pandemic influenza A (H1N1) in Argentina. N Engl J Med. 2010 Jan 7;362(1):45-55. doi: 10.1056/NEJMoa0907673. Epub 2009 Dec 23.
PubMed 20032320Kumar A, Zarychanski R, Pinto R, Cook DJ, Marshall J, Lacroix J, Stelfox T, Bagshaw S, Choong K, Lamontagne F, Turgeon AF, Lapinsky S, Ahern SP, Smith O, Siddiqui F, Jouvet P, Khwaja K, McIntyre L, Menon K, Hutchison J, Hornstein D, Joffe A, Lauzier F, Singh J, Karachi T, Wiebe K, Olafson K, Ramsey C, Sharma S, Dodek P, Meade M, Hall R, Fowler RA; Canadian Critical Care Trials Group H1N1 Collaborative. Critically ill patients with 2009 influenza A(H1N1) infection in Canada. JAMA. 2009 Nov 4;302(17):1872-9. doi: 10.1001/jama.2009.1496. Epub 2009 Oct 12.
PubMed 19822627Weigl JA, Puppe W, Schmitt HJ. The incidence of influenza-associated hospitalizations in children in Germany. Epidemiol Infect. 2002 Dec;129(3):525-33. doi: 10.1017/s0950268802007707.
PubMed 12558335
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Active, Epidemiological Surveillance Study on Influenza-related Hospitalizations to Intensive Care Units and Fatalities in Paediatric Hospitals in Bavaria Covering the Influenza Seasons 2010/2011 and 2011/2012
- ClinicalTrials.gov ID
- NCT01286285
- Acronym / sponsor ID
- UNIV HOSP WUERZBURG 7106877
- Conditions
- Influenza, Acute Respiratory Infection
- Keywords
- influenza, acute respiratory infections, paediatric, intensive care units, epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- University Children's Hospital, WuerzburgUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, University of Wuerzburg
- Study start
- Oct 2010
- Study completion
- Mar 2012 (estimated)
- First posted
- 31 Jan 2011 (estimated)
- 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.
The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units. Furthermore, the proportion of these children from all children hospitalized to paediatric intensive care units with acute respiratory infections will be established.
Detailed description
Accurate epidemiological data on severe influenza-associated hospitalizations and fatalities in children are lacking in Germany. The purpose of this study is primarily, to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units due to suspected acute respiratory infections/ influenza/ influenza-triggered complications and in children developing influenza during paediatric intensive care unit hospitalization, as well as the number of influenza-associated fatalities. In addition we aim at assessing clinical features, severity, risk factors, complications, diagnostic procedures, treatment and outcome of severe, laboratory-confirmed influenza (and other acute respiratory infections) in these children. Another objective is to estimate the proportion of laboratory-confirmed influenza cases in all children hospitalized to paediatric intensive care units with acute respiratory infections and to evaluate the number and proportion of paediatric intensive care unit hospitalizations due to other viral acute respiratory infections. Additional aims are to estimate the (minimum) incidence of severe influenza-associated hospitalizations in Bavarian children and to estimate the (minimum) incidences of other acute respiratory infections.
Ideally, this study will be conducted between October 2010 and March 2012 in all Bavarian (Germany) hospitals with paediatric intensive care units or paediatric intensive care beds (neonatology excluded). To optimize reporting there will be one study physician at each site responsible for documentation, diagnostic procedures and queries. The local study physician will receive an initiation visit at the start of each season, and will be contacted by the study coordination (situated at the University Children's Hospital in Wuerzburg) bi-weekly by phone. This local study physician summarizes the paediatric intensive care unit admittance in a log sheet, documents epidemiological, demographical, and clinical data in a questionnaire for all suspected acute respiratory infections/influenza patients with parental informed consent (pseudonymous data only), and draws a nasopharyngeal swab or -wash if indicated as routine procedure. A sample will be sent to the central laboratory (Institute for Virology and Immunobiology, University of Wuerzburg) for analysis (influenza-polymerase chain reaction, influenza virus subtyping, other viral acute respiratory infections (respiratory syncytial virus, parainfluenza 1-4, humane metapneumovirus, adenoviruses, rhinoviruses, enteroviruses). The central laboratory will analyse the samples timely and report the results to the respective study site. Additional influenza-tests may also be performed by the local laboratory, at the discretion of the hospitals. All tests, locally and performed in Wuerzburg, and their outcome should be reported in the questionnaire.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ≤16 years of age, in hospitals with paediatric intensive care units or paediatric intensive care beds in Bavaria, Germany
Key inclusion criteria (6 listed)
- Male or female subjects, ≤16 years of age at the time of paediatric intensive care unit admittance. A subject will become ineligible on his/her 17th birthday
- All patients for whom a written Informed Consent Form for study participation can be obtained
- Children presenting with suspected acute respiratory infection of the upper or lower respiratory tract, with acute respiratory infection-related symptoms, e.g. sore throat (in children ≥ 3 years old), coryza (runny nose), cough etc. or B) Children already admitted to the paediatric intensive care unit without apparent acute respiratory infection/influenza-related symptoms that develop acute respiratory infection/influenza-related symptoms within the paediatric intensive care unit or
- Children admitted to the paediatric intensive care unit with suspected influenza (even without respiratory symptoms, e.g. with neurological symptoms) or
- Children admitted to the paediatric intensive care unit with potential influenza-triggered complications and laboratory-confirmed influenza ≤14 days before paediatric intensive care unit admission (by polymerase chain reaction or other influenza test methods)
Key exclusion criteria (1 listed)
- none
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
number and proportion of influenza-/ acute respiratory infection-associated hospitalizations to paediatric intensive care units
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
* To evaluate the number of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in children ≤16 years of age * To evaluate the proportion of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in all children ≤16 years of age hospitalized to paediatric intensive care units with acute respiratory infections or suspected influenza
7 secondary outcomes
health status at discharge
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
severity of disease
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
symptoms and complications
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
comparison between influenza A and B as well as seasonal and new influenza
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
comparison of different influenza tests
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
number of acute respiratory infection-associated hospitalizations to paediatric intensive care units, comparison with influenza-associated hospitalizations to paediatric intensive care units
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
number of hospitalizations related to the corresponding population
Time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
- Background: PubMed 15745400Milne BG, Williams S, May ML, Kesson AM, Gillis J, Burgess MA. Influenza A associated morbidity and mortality in a Paediatric Intensive Care Unit. Commun Dis Intell Q Rep. 2004;28(4):504-9. doi: 10.33321/cdi.2004.28.58.
- Background: PubMed 16822994Poehling KA, Edwards KM, Weinberg GA, Szilagyi P, Staat MA, Iwane MK, Bridges CB, Grijalva CG, Zhu Y, Bernstein DI, Herrera G, Erdman D, Hall CB, Seither R, Griffin MR; New Vaccine Surveillance Network. The underrecognized burden of influenza in young children. N Engl J Med. 2006 Jul 6;355(1):31-40. doi: 10.1056/NEJMoa054869.
- Background: PubMed 16804428Rojo JC, Ruiz-Contreras J, Fernandez MB, Marin MA, Folgueira L. Influenza-related hospitalizations in children younger than three years of age. Pediatr Infect Dis J. 2006 Jul;25(7):596-601. doi: 10.1097/01.inf.0000220208.59965.95.
- Background: PubMed 18829805Finelli L, Fiore A, Dhara R, Brammer L, Shay DK, Kamimoto L, Fry A, Hageman J, Gorwitz R, Bresee J, Uyeki T. Influenza-associated pediatric mortality in the United States: increase of Staphylococcus aureus coinfection. Pediatrics. 2008 Oct;122(4):805-11. doi: 10.1542/peds.2008-1336.
- Background: PubMed 20032320Libster R, Bugna J, Coviello S, Hijano DR, Dunaiewsky M, Reynoso N, Cavalieri ML, Guglielmo MC, Areso MS, Gilligan T, Santucho F, Cabral G, Gregorio GL, Moreno R, Lutz MI, Panigasi AL, Saligari L, Caballero MT, Egues Almeida RM, Gutierrez Meyer ME, Neder MD, Davenport MC, Del Valle MP, Santidrian VS, Mosca G, Garcia Dominguez M, Alvarez L, Landa P, Pota A, Bolonati N, Dalamon R, Sanchez Mercol VI, Espinoza M, Peuchot JC, Karolinski A, Bruno M, Borsa A, Ferrero F, Bonina A, Ramonet M, Albano LC, Luedicke N, Alterman E, Savy V, Baumeister E, Chappell JD, Edwards KM, Melendi GA, Polack FP. Pediatric hospitalizations associated with 2009 pandemic influenza A (H1N1) in Argentina. N Engl J Med. 2010 Jan 7;362(1):45-55. doi: 10.1056/NEJMoa0907673. Epub 2009 Dec 23.
- Background: PubMed 19822627Kumar A, Zarychanski R, Pinto R, Cook DJ, Marshall J, Lacroix J, Stelfox T, Bagshaw S, Choong K, Lamontagne F, Turgeon AF, Lapinsky S, Ahern SP, Smith O, Siddiqui F, Jouvet P, Khwaja K, McIntyre L, Menon K, Hutchison J, Hornstein D, Joffe A, Lauzier F, Singh J, Karachi T, Wiebe K, Olafson K, Ramsey C, Sharma S, Dodek P, Meade M, Hall R, Fowler RA; Canadian Critical Care Trials Group H1N1 Collaborative. Critically ill patients with 2009 influenza A(H1N1) infection in Canada. JAMA. 2009 Nov 4;302(17):1872-9. doi: 10.1001/jama.2009.1496. Epub 2009 Oct 12.
- Background: PubMed 12558335Weigl JA, Puppe W, Schmitt HJ. The incidence of influenza-associated hospitalizations in children in Germany. Epidemiol Infect. 2002 Dec;129(3):525-33. doi: 10.1017/s0950268802007707.
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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.
Johannes G. Liese, MD, MSc principal investigator
University Children's Hospital Wuerzburg, Paediatric Infectiology and Immunology, Josef-Schneider-Str. 2, 97080 Wuerzburg, Germany
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 Influenza and Acute Respiratory Infection, run by University Children's Hospital, Wuerzburg at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 2011. 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 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?
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?
number and proportion of influenza-/ acute respiratory infection-associated hospitalizations to paediatric intensive care units (time frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012)). 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 NCT01286285, which also lists 7 linked publications.
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 Jan 2011.