The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia

Ventilator Associated Pneumonia Clinical Trial

— SCAHAVAP  

Official title:

The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02203110
• Other study ID #: Severe pneumonia
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2014
• Last updated: July 25, 2014
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2014
• Source: University Medical Centre Ljubljana
• Contact: Primoz Karner
• Phone: +386 51 345616
• Email: primoz.karner[@]guest.arnes.si
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to determine if the clinical course of pneumonia is more severe when both, bacterial and viral pathogens are find as possible causative agent and how does it affect treatment.

Description:

Basic demographic data of the patients (age, gender), data on concomitant diseases and epidemiological circumstances will be collected

Severity of illness will be assessed by APACHE II (at day 1) and SOFA (at day 1,2,3 and 7) scoring system

Following laboratory tests will be performed at day 1, 2,3 and 7.:

• blood count analysis

• differential blood count

• C- reactive protein, procalcitonin

• glucose, urea, potassium, sodium, chloride, magnesium, creatinine, bilirubin, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase, gamma-glutamyl transpeptidase , alpha-amylase, lipase, creatine kinase, lactate dehydrogenase, myoglobin

• arterial blood gas analysis

• tests of hemostasis.

Additional 2 mL of blood will be taken at day 1 and day 21 (or later), due to paired serologic testing

To establish the presence of potential pathogens we will perform following microbiological investigations:

• cultivation of 2 pairs of blood cultures in all patients

• cultivation of sputum or quantitative cultivation of tracheal aspirate in nonintubated patients

• quantitative cultivation of tracheal aspirate or bronchoalveolar lavage in intubated patients

• testing the presence of soluble Legionella antigen in urine in all patients

• testing the presence of genetic material of respiratory viruses (influenza A, influenza B, respiratory syncytial virus , adenovirus, bocavirus, coronavirus, metapneumovirus, parainfluenza virus, rhinovirus) by qualitative polymerase chain reaction (PCR) in nasopharyngeal swabs in all patients, in the tracheal aspirate in nonintubated patients and in tracheal aspirate or bronchoalveolar lavage fluid in intubated patients

• testing the presence of mycoplasmal, legionella and chlamydial DNA by qualitative PCR in nasopharyngeal smears in all patients, in the tracheal aspirate in nonintubated patients and in bronchoalveolar lavage fluid or in tracheal aspirate in intubated patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: diagnosis of

• severe community acquired pneumonia or

• severe hospital acquired pneumonia or

• ventilator--associated pneumonia

Exclusion Criteria:

• antibiotic treatment of actual episode of pneumonia for more than 24 hours

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Community Acquired Pneumonia
• Hospital Acquired Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
Slovenia	Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic		each patient will be assessed at enrollment and follow-up for 2 months	No