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

NCT ID: NCT01343979

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

Conditions

Clinically Suspected H1N1 Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

positive

Patients with clinically suspected H1N1 infection confirmed by positive H1N1 PCR

No interventions assigned to this group

negative

Patients with clinically suspected H1N1 infection and negative H1N1 PCR

No interventions assigned to this group

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Robert Krause, MD

ao.Univ.Prof.Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Hoenigl, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Robert Krause, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Holger Flick, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Hospital Graz

Locations

Medical University Hospital of Graz

Graz, Styria, Austria

Countries

Austria

Other Identifiers

23-049

Identifier Type: -

Identifier Source: org_study_id