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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

Tracking Information
First Submitted Date December 2, 2009
First Posted Date December 3, 2009
Last Update Posted Date June 25, 2020
Study Start Date October 2009
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 2, 2009)
To identify risk factors for admission to the ICU and mortality [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Characteristics and Outcomes in Patients Diagnosed With Novel Influenza A (H1N1)
Official Title Clinical Characteristics and Outcomes in Patients Diagnosed With Novel Influenza A (H1N1)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Probability Sample
Study Population patients diagnosed clinically with H1N1
Condition Influenza
Intervention Not Provided
Study Groups/Cohorts patients with H1N1
patients who are clinical found to be positive for H1N1 will be enrolled
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 2, 2009)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed with H1N1

Exclusion Criteria:

  • does not meet entry criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Fernanda Silveira, MD 412-648-6401 silveirafd@upmc.edu
Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 dlp5@dom.pitt.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01024673
Other Study ID Numbers IRB#: PRO09090326
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fernanda Silveira, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Not Provided
Investigators
Principal Investigator: Fernanda Silveira, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2020