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

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.

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.

Study Overview

• Status: Completed
• Conditions: Clinically Suspected H1N1 Infection

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University Hospital of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
positive; Patients with clinically suspected H1N1 infection confirmed by positive H1N1 PCR
negative; Patients with clinically suspected H1N1 infection and negative H1N1 PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical presentation of H1N1 compared to other viral infections	2 years

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Martin Hoenigl, MD, Medical University of Graz; Principal Investigator: Holger Flick, MD, Medical University Hospital Graz

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 28, 2011

Study Record Updates

• Last Update Posted (Estimate): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 23-049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No