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 9, 2017
|Condition or disease|
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|
|Estimated Enrollment :||600 participants|
|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|
patients with H1N1
patients who are clinical found to be positive for H1N1 will be enrolled
- 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 ]
- To identify risk factors for admission to the ICU and mortality [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA
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
|Contact: Fernanda Silveira, MDfirstname.lastname@example.org|
|Contact: Diana Lynn Pakstis, RN, BSNemail@example.com|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Fernanda Silveira, MD 412-648-6401 firstname.lastname@example.org|
|Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 email@example.com|
|Principal Investigator: Fernanda Silveira, MD|
|Principal Investigator:||Fernanda Silveira, MD||University of Pittsburgh|