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NCT01024673 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01024673
Other study ID # IRB#: PRO09090326
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2009
Est. completion date August 19, 2021

Study information
Verified date August 2021
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date August 19, 2021
Est. primary completion date August 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with H1N1 Exclusion Criteria: - does not meet entry criteria

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States UPMC Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To identify risk factors for admission to the ICU and mortality 5 years
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