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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01024673
First received: December 2, 2009
Last updated: July 29, 2013
Last verified: July 2013
  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)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

patients diagnosed clinically with H1N1

Criteria

Inclusion Criteria:

  • Patients diagnosed with H1N1

Exclusion Criteria:

  • does not meet entry criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024673

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

Locations
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
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: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
H1N1

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014