Novel Influenza ANCT01046331
Novel Influenza A (H1N1) Surveillance Registry
An observational study of Novel Influenza A and H1N1, run by National Heart, Lung, and Blood Institute (NHLBI) at 86 sites in United States.
Trial summary
The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Novel Influenza A, H1N1, Influenza
- How many people
- 894 participants
- Where
- 86 sitesUnited States
- Study dates
- Oct 2009to Oct 2010
- 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: Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
Who may be able to join
- Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection
Who cannot join
- Influenza-like illness due to non-influenza disease and negative testing for influenza
Trial locations and contacts
86 sites in 1 country.
86 sites in 1 country
United States86 sites
Alaska Native Medical Center
Anchorage, Alaska
The Children's Hospital at Providence
Anchorage, Alaska
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia
Denver's Children Hospital
Aurora, Colorado
Dell Children's Medical Center of Central Texas
Austin, Texas
Johns Hopkins Bayview Medical Center
Baltimore, Maryland
Johns Hopkins Children's Center
Baltimore, Maryland
Johns Hopkins Hospital
Baltimore, Maryland
Union Memorial Hospital
Baltimore, Maryland
University of Maryland Shock Trauma Center
Baltimore, Maryland
Earl K. Long Medical Center
Baton Rouge, Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana
Boston Medical Center
Boston, Massachusetts
Children's Hospital Boston
Boston, Massachusetts
University of North Carolina
Chapel Hill, North Carolina
University of Virginia Children's Medical Center
Charlottesville, Virginia
University of Virginia Medical Center
Charlottesville, Virginia
Children's Memorial Hospital
Chicago, Illinois
Cleveland Clinic Foundation
Cleveland, Ohio
MetroHealth Medical Center
Cleveland, Ohio
University Hospitals of Cleveland
Cleveland, Ohio
Nationwide Children' Hospital
Columbus, Ohio
University of Texas Southwestern Children's Medical Center
Dallas, Texas
Centura St. Anthony Central Hospital
Denver, Colorado
Denver Health Medical Center
Denver, Colorado
Rose Medical Center
Denver, Colorado
University of Colorado Health Sciences Center
Denver, Colorado
Duke University Children's Hospital
Durham, North Carolina
Duke University Medical Center
Durham, North Carolina
Durham Regional Medical Center
Durham, North Carolina
Providence Hospital
Everett, Washington
University of San Francisco-Fresno Medical Center
Fresno, California
Helen DeVos Children's Hospital
Grand Rapids, Michigan
Moses Cone Health System
Greensboro, North Carolina
Wesley Long Community Hospital
Greensboro, North Carolina
Connecticut Children's Medical Center
Hartford, Connecticut
Penn State Children's Hospital
Hershey, Pennsylvania
Kapi'olani Center for Women and Children
Honolulu, Hawaii
Baylor College of Medicine
Houston, Texas
Texas Children's Hospital
Houston, Texas
Mayo Clinic at Jacksonville
Jacksonville, Florida
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire
Arkansas Children's Hiospital
Little Rock, Arkansas
Children's Hospital Los Angeles
Los Angeles, California
Kosair Children's Hospital
Louisville, Kentucky
Holt'z Children's Hospital
Miami, Florida
Miami Children's Hospital
Miami, Florida
Children's Hospital of Wisconsin
Milwaukee, Wisconsin
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota
University of Minnesota Children's Hospital
Minneapolis, Minnesota
Intermountain Medical Center
Murray, Utah
Monroe Carell Children's Hospital at Vanderbilt
Nashville, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee
Yale-New Haven Children's Hospital
New Haven, Connecticut
Medical Center of Louisiana
New Orleans, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana
Children's Hospital and Research Center Oakland
Oakland, California
McKay-Dee Hospital
Ogden, Utah
Children's Hospital of Nebraska
Omaha, Nebraska
Children's Hospital of Orange County
Orange, California
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Phoenix Children's Hospital
Phoenix, Arizona
Doernbecher Children's Hospital
Portland, Oregon
Utah Valley Regional Medical Center
Provo, Utah
University of Rochester Medical Center
Rocherster, New York
Rochester Methodist Hospital
Rochester, Minnesota
St. Mary's Hospital, Mayo Clinic
Rochester, Minnesota
University of California, Davis Medical Center
Sacramento, California
LDS Hospital
Salt Lake City, Utah
Primary Children's Medical Center
Salt Lake City, Utah
UCSF Children's Medical Center
San Francisco, California
UCSF-Moffitt Hospital
San Francisco, California
UCSF-San Francisco General Hospital
San Francisco, California
University of California, San Francisco (UCSF)-Moffitt Hospital
San Francisco, California
Harborview Medical Center
Seattle, Washington
Seattle Children's Hospital
Seattle, Washington
University of Washington
Seattle, Washington
Baystate Medical Center
Springfield, Massachusetts
SSM Cardinal Glennon Children's Medical Center
St Louis, Missouri
St. Louis Children's Hospital
St Louis, Missouri
Children's Hospital of Montefiore
The Bronx, New York
Children's Hospital at St. Francis
Tulsa, Oklahoma
Children's National Medical Center
Washington D.C., District of Columbia
Washington Hospital Center
Washington D.C., District of Columbia
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina
About this study
The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.
- Conditions
- Novel Influenza A, H1N1, Influenza
- Medical subject headings
- Influenza, Human
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 |
|---|---|---|
| Adult H1N1 | Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection | |
| Pediatric H1N1 | Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel Influenza AStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Enrolment
- 894 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- B. Taylor Thompson, MD, Principal investigator, Massachusetts General HospitalAdrienne G Randolph, MD, MSc, Principal investigator, Boston Children's HospitalTodd W Rice, MD, MSc, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046331
- Sponsor's protocol ID
- 688
- Other IDs
- N01HR056179, HSN268200536179C
- Status last verified
- Nov 2010
- First submitted
- 8 Jan 2010
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Influenza A (H1N1) Surveillance Registry
- ClinicalTrials.gov ID
- NCT01046331
- Acronym / sponsor ID
- 688
- Conditions
- Novel Influenza A, H1N1, Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 894 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 Jan 2010 (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 demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult H1N1 | – | –Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection |
| Pediatric H1N1 | – | –Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
Key inclusion criteria (1 listed)
- Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection
Key exclusion criteria (1 listed)
- Influenza-like illness due to non-influenza disease and negative testing for influenza
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
Not reported in the source record.
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 14 Apr 2016.
- Related InfoLink provided by the sponsor.
Related trials for Novel Influenza A
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
Active, not recruitingPhase 2
A Study of Annual Doses of MK-1406/CD388 in Healthy Adults (MK-1406-006/CD388.SQ.2.07)
Healthy Participants
Not yet recruitingPhase 2
A Novel Cold and Flu Herbal Blend for Reducing the Duration and Severity of the Common Cold
URTI, Common Cold
RecruitingPhase 1/2
Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)
SARS-CoV-2, Influenza, Human
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.
B. Taylor Thompson, MD principal investigator
Massachusetts General Hospital
Adrienne G Randolph, MD, MSc principal investigator
Boston Children's Hospital
Todd W Rice, MD, MSc principal investigator
Vanderbilt University
86 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Novel Influenza A and H1N1, run by National Heart, Lung, and Blood Institute (NHLBI) at 86 sites in United States.
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 1 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States. 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.
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 14 Apr 2016.