NCT01024673

Brief Summary

This is study where medical record information will be collected as well as collection of excess biological samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 15, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

11.9 years

First QC Date

December 2, 2009

Last Update Submit

August 20, 2021

Conditions

Influenza

Keywords

H1N1

Outcome Measures

Primary Outcomes (1)

  • To describe the clinical characteristic and outcomes of the patients admitted to UPMC Presbyterian campus with infection due to novel influenza A (H1N1).

    5 year

Secondary Outcomes (1)

  • To identify risk factors for admission to the ICU and mortality

    5 years

Study Arms (1)

patients with H1N1

patients who are clinical found to be positive for H1N1 will be enrolled

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients diagnosed clinically with H1N1

You may qualify if:

  • Patients diagnosed with H1N1

You may not qualify if:

  • does not meet entry criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All the biologic samples and data will be under the control of the principal investigator . To protect confidentiality, all personal identifiers will be removed and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators will keep the samples and data indefinitely. All samples will be stored in the principal investigators laboratory in Scaife Hall, Room 835.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Fernanda Silveira, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

October 15, 2009

Primary Completion

August 19, 2021

Study Completion

August 19, 2021

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

US(1)