Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

894

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach

1 country

86 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

October 1, 2009

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed

Last Updated

April 14, 2016

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

January 8, 2010

Last Update Submit

April 13, 2016

Conditions

Novel Influenza A H1N1 Influenza

Study Arms (2)

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

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.

You may qualify if:

Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection

You may not qualify if:

Influenza-like illness due to non-influenza disease and negative testing for influenza

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Heart, Lung, and Blood Institute (NHLBI)lead

Study Sites (86)

Alaska Native Medical Center

Anchorage, Alaska, United States

Location

The Children's Hospital at Providence

Anchorage, Alaska, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, United States

Location

Arkansas Children's Hiospital

Little Rock, Arkansas, United States

Location

University of San Francisco-Fresno Medical Center

Fresno, California, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, United States

Location

Children's Hospital and Research Center Oakland

Oakland, California, United States

Location

Children's Hospital of Orange County

Orange, California, United States

Location

University of California, Davis Medical Center

Sacramento, California, United States

Location

UCSF Children's Medical Center

San Francisco, California, United States

Location

UCSF-Moffitt Hospital

San Francisco, California, United States

Location

UCSF-San Francisco General Hospital

San Francisco, California, United States

Location

University of California, San Francisco (UCSF)-Moffitt Hospital

San Francisco, California, United States

Location

Denver's Children Hospital

Aurora, Colorado, United States

Location

Centura St. Anthony Central Hospital

Denver, Colorado, United States

Location

Denver Health Medical Center

Denver, Colorado, United States

Location

Rose Medical Center

Denver, Colorado, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Location

Yale-New Haven Children's Hospital

New Haven, Connecticut, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, United States

Location

Mayo Clinic at Jacksonville

Jacksonville, Florida, United States

Location

Holt'z Children's Hospital

Miami, Florida, United States

Location

Miami Children's Hospital

Miami, Florida, United States

Location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Location

Kapi'olani Center for Women and Children

Honolulu, Hawaii, United States

Location

Children's Memorial Hospital

Chicago, Illinois, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, United States

Location

Earl K. Long Medical Center

Baton Rouge, Louisiana, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Location

Medical Center of Louisiana

New Orleans, Louisiana, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Location

Johns Hopkins Bayview Medical Center