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

Clinically Suspected H1N1 Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343979
• Other study ID #: 23-049
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: April 2, 2015
• Start date: October 2010
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Clinically Suspected H1N1 Infection
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
Austria	Medical University Hospital of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical presentation of H1N1 compared to other viral infections		2 years	No