Community Acquired PneumoniaSCAHAVAPNCT02203110
The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia
An observational study of Community Acquired Pneumonia and Hospital Acquired Pneumonia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia, Hospital Acquired Pneumonia, Ventilator Associated Pneumonia
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- Jan 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admited to Intensive Care Unit Department of Infectious Diseases University Medical Centre Ljubljana due to severe pneumonia or pneumonia will develop during their stay in ICU.
Who may be able to join
- severe community acquired pneumonia or
- severe hospital acquired pneumonia or
- ventilator--associated pneumonia
Who cannot join
- antibiotic treatment of actual episode of pneumonia for more than 24 hours
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2
Ljubljana, 1000
Primoz Karner, +386 51 345616, primoz.karner@guest.arnes.si
Matjaz Jereb, +386 1 522 8170, matjaz.jereb@kclj.si
About this study
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.
Read the detailed 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
- Conditions
- Community Acquired Pneumonia, Hospital Acquired Pneumonia, Ventilator Associated Pneumonia
- Keywords
- simultaneous bacterial and viral pneumonia
- Medical subject headings
- Community-Acquired Pneumonia, Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated, Pneumonia, Viral
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic
Measured: each patient will be assessed at enrollment and follow-up for 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Responsible party
- Principal investigator, Primoz Karner, University Medical Centre Ljubljana
- Investigators
- Primoz Karner, Principal investigator, Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203110
- Sponsor's protocol ID
- Severe pneumonia
- Acronym
- SCAHAVAP
- Status last verified
- Jul 2014
- First submitted
- 25 Jul 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia
- ClinicalTrials.gov ID
- NCT02203110
- Acronym / sponsor ID
- SCAHAVAP / Severe pneumonia
- Conditions
- Community Acquired Pneumonia, Hospital Acquired Pneumonia, Ventilator Associated Pneumonia
- Keywords
- simultaneous bacterial and viral pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admited to Intensive Care Unit Department of Infectious Diseases University Medical Centre Ljubljana due to severe pneumonia or pneumonia will develop during their stay in ICU.
Key inclusion criteria (3 listed)
- severe community acquired pneumonia or
- severe hospital acquired pneumonia or
- ventilator--associated pneumonia
Key exclusion criteria (1 listed)
- antibiotic treatment of actual episode of pneumonia for more than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic
Time frame: each patient will be assessed at enrollment and follow-up for 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Primoz Karner principal investigator
Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia and Hospital Acquired Pneumonia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Primoz Karner (+386 51 345616, primoz.karner@guest.arnes.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic (time frame: each patient will be assessed at enrollment and follow-up for 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.