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

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ClinicalTrials.gov Identifier: NCT01024673
Recruitment Status : Recruiting
First Posted : December 3, 2009
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Fernanda Silveira, University of Pittsburgh

Study Description
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Brief Summary:
This is study where medical record information will be collected as well as collection of excess biological samples.

Condition or disease
Influenza

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Characteristics and Outcomes in Patients Diagnosed With Novel Influenza A (H1N1)
Study Start Date : October 2009
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Group/Cohort
patients with H1N1
patients who are clinical found to be positive for H1N1 will be enrolled


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To identify risk factors for admission to the ICU and mortality [ Time Frame: 5 years ]

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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients diagnosed clinically with H1N1
Criteria

Inclusion Criteria:

  • Patients diagnosed with H1N1

Exclusion Criteria:

  • does not meet entry criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024673


Contacts
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Contact: Fernanda Silveira, MD 412-648-6401 silveirafd@upmc.edu
Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 dlp5@dom.pitt.edu

Locations
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United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Fernanda Silveira, MD    412-648-6401    silveirafd@upmc.edu   
Contact: Diana Lynn Pakstis, RN, BSN    412-648-6553    dlp5@pitt.edu   
Principal Investigator: Fernanda Silveira, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Fernanda Silveira, MD University of Pittsburgh
More Information
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Responsible Party: Fernanda Silveira, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01024673    
Other Study ID Numbers: IRB#: PRO09090326
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Keywords provided by Fernanda Silveira, University of Pittsburgh:
H1N1
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases