Influenza A H1N1: Retrospective Analysis of PCR Confirmed Cases of H1N1 Infections in Styria - Risk Factors, Clinical Features and Outcome.

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Robert Krause, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01343979
First received: April 27, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This retrospective study will analyse all PCR-proven H1N1 cases from the influenza season 2009/2010 treated within the styrian "LKH hospital network". For this purpose all PCR-positive case files are reviewed in Medocs (electronic patients database) and data regarding clinical presentation, laboratory and radiological findings, treatment, outcome and preexisting underlying chronic illnesses will be systematically collected. In a second step the same data collection will be performed in a group of PCR-negative patients, which were tested during the influenza season 2009/2010 for influenza-like illness. The data from the PCR-positive group will be compared to the data from the PCR-negative group. We expect significant differences between the proven and unproven group regarding the primary presentation at hospital. Based on these results a clinical score will be developed. This score should improve H1N1 case identification in emergency departments, even if specific diagnostic test are negative (rapid antigen testing) or still pending (PCR), reduce the number of missed hospitalized H1N1 infection and optimize the decision making process in emergency departments regarding which patient has to be admitted with infection control measures and which not, and as infection control measures are expensive (face masks, gloves) and limited (isolation room), such a score should also reduce unnecessary expense. To evaluate the sensitivity and specificity of the score a prospective study will follow in the influenza season 2010/2011.


Condition
Clinically Suspected H1N1 Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Influenza A H1N1: Retrospective Analysis of PCR Confirmed Cases of H1N1 Infections in Styria - Risk Factors, Clinical Features and Outcome. Development of a Clinical Score for Suspected H1N1 Infection.

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • clinical presentation of H1N1 compared to other viral infections [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: October 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
positive
Patients with clinically suspected H1N1 infection confirmed by positive H1N1 PCR
negative
Patients with clinically suspected H1N1 infection and negative H1N1 PCR

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients tested for influenza illness by PCR of respiratory tract specimens at the Institute of Hygiene, Karl-Franzens-University Graz, and at the Institute for Hospital Hygiene and Microbiology, KAGES Graz.

Criteria

Inclusion Criteria:

  • Inclusion criteria:

    1. All patients tested for influenza illness by PCR of respiratory tract specimens at the Institute of Hygiene, Karl-Franzens-University Graz, and at the Institute for Hospital Hygiene and Microbiology, KAGES Graz.
    2. Stratification according to the following definition:
  • PCR-negative influenza-like illness (ILI) is defined as febrile illness tested by PCR for the presence of influenza infection but finally not proved as influenza infection.
  • Influenza illness is defined as febrile illness confirmed by positive PCR as true influenza infection.

Exclusion Criteria:

  • NONE
  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: NCT01343979

Locations
Austria
Medical University Hospital of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Martin Hoenigl, MD    +43316385 ext 13150    martin.hoenigl@medunigraz.at   
Principal Investigator: Martin Hoenigl, MD         
Principal Investigator: Robert Krause, MD         
Principal Investigator: Holger Flick, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Martin Hoenigl, MD Medical University of Graz
Principal Investigator: Robert Krause, MD Medical University of Graz
Principal Investigator: Holger Flick, MD Medical University Hospital Graz
  More Information

No publications provided

Responsible Party: Robert Krause, MD, ao.Univ.Prof.Dr, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01343979     History of Changes
Other Study ID Numbers: 23-049
Study First Received: April 27, 2011
Last Updated: August 6, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on October 01, 2014