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

NCT ID: NCT01024673

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-15

Study Completion Date

2021-08-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with H1N1

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with H1N1

Exclusion Criteria

* does not meet entry criteria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Fernanda P Silveira, MD, MS

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernanda Silveira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#: PRO09090326

Identifier Type: -

Identifier Source: org_study_id

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