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
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Tracking Information | |||||||||
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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 |
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 |
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. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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.
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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
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 |
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PRS Account | University of Pittsburgh | ||||||||
Verification Date | June 2020 |