Clinical Characteristics and Outcomes in Patients Diagnosed With Novel Influenza A (H1N1)
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Purpose
This is study where medical record information will be collected as well as collection of excess biological samples.
| Condition |
|---|
|
Influenza |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Clinical Characteristics and Outcomes in Patients Diagnosed With Novel Influenza A (H1N1) |
- 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 ] [ Designated as safety issue: No ]
- To identify risk factors for admission to the ICU and mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
patients with H1N1
patients who are clinical found to be positive for H1N1 will be enrolled
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
patients diagnosed clinically with H1N1
Inclusion Criteria:
- Patients diagnosed with H1N1
Exclusion Criteria:
- does not meet entry criteria
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01024673
| Contact: Fernanda Silveira, MD | 412-648-6401 | silveirafd@upmc.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN | 412-648-6553 | dlp5@dom.pitt.edu |
| 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 | |
| Principal Investigator: | Fernanda Silveira, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01024673 History of Changes |
| Other Study ID Numbers: | IRB#: PRO09090326 |
| Study First Received: | December 2, 2009 |
| Last Updated: | December 5, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
H1N1 |
ClinicalTrials.gov processed this record on March 03, 2015