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Clinical Trials/NCT01024673
NCT01024673
Completed
Not Applicable

Clinical Characteristics and Outcomes in Patients Diagnosed With Novel Influenza A (H1N1)

University of Pittsburgh1 site in 1 country38 target enrollmentOctober 15, 2009
ConditionsInfluenza

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Influenza
Sponsor
University of Pittsburgh
Enrollment
38
Locations
1
Primary Endpoint
To describe the clinical characteristic and outcomes of the patients admitted to UPMC Presbyterian campus with infection due to novel influenza A (H1N1).
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

Patients diagnosed with H1N1 will be asked to consent and allow us to collect the following: From the medical record the research staff will review and record the results of the test/procedures (x-rays, CT-scans, EKG (electrocardiogram), etc.) that are part of the subjects clinical care and the results will become part of the research record. We will also collect and record vitals signs, including temperature, blood pressure, heart rate, respiratory rate and record the list of medications the subject is taking. We will also collect information on demographics (address, phone number, etc.) including gender, race and ethnicity, review and record past medical history and any non medical procedures that the subject may have had within the past two months. This information will be collected by the research coordinator from the medical record. The clinical physician ordered a nasopharyngeal swab or obtained bronchoalveolar lavage fluid to diagnose novel Influenza A (H1N1). We will collect this swab or fluid after the diagnosis has been made, to evaluate the genetic material of the virus. This swab or fluid is normally discarded once the diagnosis is made. collection of data will be done by the research staff and should not take any longer than 15-20 minutes. The clinical samples that would have been discarded will be collected by the research staff from microbiology and pathology and delivered to the research lab in Scaife. The investigators will do a 6 month follow up phone call to check the health status of the participant. This will be done by the research coordinator and take no more than 5-10 minutes of the subject's time.

Registry
clinicaltrials.gov
Start Date
October 15, 2009
End Date
August 19, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fernanda P Silveira, MD, MS

MD

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with H1N1

Exclusion Criteria

  • does not meet entry criteria

Outcomes

Primary Outcomes

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

Time Frame: 5 year

Secondary Outcomes

  • To identify risk factors for admission to the ICU and mortality(5 years)

Study Sites (1)

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