Hospital Acquired PneumoniaNCT03039998
Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia
An observational study of Hospital Acquired Pneumonia, run by University Hospital Olomouc.
Trial summary
The main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Pneumonia
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2015
- 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: The patients hospitalized in the Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc fulfilling HAP criteria will be enrolled in the study: presence of newly developed or progressive infiltrates on chest radiographs after minimum of 48hours of hospitalization plus at least two other signs of respiratory tract infection: temperature >38 °C, purulent sputum, leukocytosis >10x103/mm3 or leukopenia <4x103/mm3, signs of inflammation on auscultation, cough and/or respiratory insufficiency with oxygenation index (Horowitz) PaO2/ FiO2 ≤300 mm Hg. Clinically ongoing lung inflammation is verified by chest radiograph or CT in the mechanically ventilated patient.
Who may be able to join
- clinical signs of HAP
- need for intubation and mechanical ventilation
Who cannot join
- inability to obtain samples in 24 hours after clinical diagnosis of HAP
About this study
The main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents is performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.
Read the detailed description
The main objective of project will be comparing validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Obtained results of different methods will enable to determine if the bronchial secretion sample, stomach content sample or oropharyngeal smear are comparable to precise but technically difficult protected brush. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP will be other priorities of the project. The role of atypical and fungal pathogens in HAP initiation will be discovered as well. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents will be performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.
Project fulfills program objectives of molecular-biologic approaches and research support in infectious diseases domain. It will make contribution to faster and more precise HAP diagnosis and adequate antibiotic therapy.
- Conditions
- Hospital Acquired Pneumonia
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HAP Patients | HAP, intubated and mechanically ventilated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.
Obtaining 4 types of agent samples: endotracheal aspirate, gastric aspirate, oropharyngeal swab and protected specimen brushing when clinical signs of HAP arisen and after 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hospital Acquired PneumoniaStudies of the same condition, open and under way.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Radovan Uvizl, University Hospital Olomouc
- Investigators
- Tomáš Gabrhelík, MD, PhD, Principal investigator, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039998
- Sponsor's protocol ID
- NT14382
- Status last verified
- Jan 2017
- First submitted
- 10 May 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.
PubMed 7637145Uvizl R, Hanulik V, Husickova V, Sedlakova MH, Adamus M, Kolar M. Hospital-acquired pneumonia in ICU patients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Dec;155(4):373-8. doi: 10.5507/bp.2011.067.
PubMed 22336651American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PubMed 15699079Craven DE, Palladino R, McQuillen DP. Healthcare-associated pneumonia in adults: management principles to improve outcomes. Infect Dis Clin North Am. 2004 Dec;18(4):939-62. doi: 10.1016/j.idc.2004.08.001.
PubMed 15555833Uvizl R, Adamus M, Cerny V, Dusek L, Jarkovsky J, Sramek V, Matejovic M, Stourac P, Kula R, Malaska J, Sevcik P. Patient survival, predictive factors and disease course of severe sepsis in Czech intensive care units: A multicentre, retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):287-97. doi: 10.5507/bp.2015.052. Epub 2015 Oct 23.
PubMed 26526190Jones RN. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S81-7. doi: 10.1086/653053.
PubMed 20597676[Pneumonia-causing bacterial pathogens in intensive care patients]. Klin Mikrobiol Infekc Lek. 2011 Aug;17(4):135-40. Czech.
PubMed 22052100Torres A, Ewig S, Lode H, Carlet J; European HAP working group. Defining, treating and preventing hospital acquired pneumonia: European perspective. Intensive Care Med. 2009 Jan;35(1):9-29. doi: 10.1007/s00134-008-1336-9. Epub 2008 Nov 7.
PubMed 18989656Kowalczyk W, Rybicki Z, Tomaszewski D, Truszczynski A, Guzek A. [The comparison of different bronchial aspirate culturing methods in patients with ventilator-associated pneumonia (VAP)]. Anestezjol Intens Ter. 2011 Apr-Jun;43(2):74-9. Polish.
PubMed 22011866Butler KL, Best IM, Oster RA, Katon-Benitez I, Lynn Weaver W, Bumpers HL. Is bilateral protected specimen brush sampling necessary for the accurate diagnosis of ventilator-associated pneumonia? J Trauma. 2004 Aug;57(2):316-22. doi: 10.1097/01.ta.0000088858.22080.cb.
PubMed 15345979Gerbeaux P, Ledoray V, Boussuges A, Molenat F, Jean P, Sainty JM. Diagnosis of nosocomial pneumonia in mechanically ventilated patients: repeatability of the bronchoalveolar lavage. Am J Respir Crit Care Med. 1998 Jan;157(1):76-80. doi: 10.1164/ajrccm.157.1.9604070.
PubMed 9445281
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT03039998
- Acronym / sponsor ID
- NT14382
- Conditions
- Hospital Acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Feb 2017 (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 main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents is performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.
Detailed description
The main objective of project will be comparing validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Obtained results of different methods will enable to determine if the bronchial secretion sample, stomach content sample or oropharyngeal smear are comparable to precise but technically difficult protected brush. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP will be other priorities of the project. The role of atypical and fungal pathogens in HAP initiation will be discovered as well. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents will be performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.
Project fulfills program objectives of molecular-biologic approaches and research support in infectious diseases domain. It will make contribution to faster and more precise HAP diagnosis and adequate antibiotic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAP Patients | – | –HAP, intubated and mechanically ventilated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients hospitalized in the Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc fulfilling HAP criteria will be enrolled in the study: presence of newly developed or progressive infiltrates on chest radiographs after minimum of 48hours of hospitalization plus at least two other signs of respiratory tract infection: temperature >38 °C, purulent sputum, leukocytosis >10x103/mm3 or leukopenia <4x103/mm3, signs of inflammation on auscultation, cough and/or respiratory insufficiency with oxygenation index (Horowitz) PaO2/ FiO2 ≤300 mm Hg. Clinically ongoing lung inflammation is verified by chest radiograph or CT in the mechanically ventilated patient.
Key inclusion criteria (2 listed)
- clinical signs of HAP
- need for intubation and mechanical ventilation
Key exclusion criteria (1 listed)
- inability to obtain samples in 24 hours after clinical diagnosis of HAP
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
Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.
Time frame: 72 hours
Obtaining 4 types of agent samples: endotracheal aspirate, gastric aspirate, oropharyngeal swab and protected specimen brushing when clinical signs of HAP arisen and after 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 7637145Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.
- Background: PubMed 22336651Uvizl R, Hanulik V, Husickova V, Sedlakova MH, Adamus M, Kolar M. Hospital-acquired pneumonia in ICU patients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Dec;155(4):373-8. doi: 10.5507/bp.2011.067.
- Background: PubMed 15699079American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
- Background: PubMed 15555833Craven DE, Palladino R, McQuillen DP. Healthcare-associated pneumonia in adults: management principles to improve outcomes. Infect Dis Clin North Am. 2004 Dec;18(4):939-62. doi: 10.1016/j.idc.2004.08.001.
- Background: PubMed 26526190Uvizl R, Adamus M, Cerny V, Dusek L, Jarkovsky J, Sramek V, Matejovic M, Stourac P, Kula R, Malaska J, Sevcik P. Patient survival, predictive factors and disease course of severe sepsis in Czech intensive care units: A multicentre, retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):287-97. doi: 10.5507/bp.2015.052. Epub 2015 Oct 23.
- Background: PubMed 20597676Jones RN. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S81-7. doi: 10.1086/653053.
- Background: PubMed 22052100[Pneumonia-causing bacterial pathogens in intensive care patients]. Klin Mikrobiol Infekc Lek. 2011 Aug;17(4):135-40. Czech.
- Background: PubMed 18989656Torres A, Ewig S, Lode H, Carlet J; European HAP working group. Defining, treating and preventing hospital acquired pneumonia: European perspective. Intensive Care Med. 2009 Jan;35(1):9-29. doi: 10.1007/s00134-008-1336-9. Epub 2008 Nov 7.
- Background: PubMed 22011866Kowalczyk W, Rybicki Z, Tomaszewski D, Truszczynski A, Guzek A. [The comparison of different bronchial aspirate culturing methods in patients with ventilator-associated pneumonia (VAP)]. Anestezjol Intens Ter. 2011 Apr-Jun;43(2):74-9. Polish.
- Background: PubMed 15345979Butler KL, Best IM, Oster RA, Katon-Benitez I, Lynn Weaver W, Bumpers HL. Is bilateral protected specimen brush sampling necessary for the accurate diagnosis of ventilator-associated pneumonia? J Trauma. 2004 Aug;57(2):316-22. doi: 10.1097/01.ta.0000088858.22080.cb.
- Background: PubMed 9445281Gerbeaux P, Ledoray V, Boussuges A, Molenat F, Jean P, Sainty JM. Diagnosis of nosocomial pneumonia in mechanically ventilated patients: repeatability of the bronchoalveolar lavage. Am J Respir Crit Care Med. 1998 Jan;157(1):76-80. doi: 10.1164/ajrccm.157.1.9604070.
- Individual participant dataSharing planned: No
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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.
Tomáš Gabrhelík, MD, PhD principal investigator
University Hospital Olomouc
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Acquired Pneumonia, run by University Hospital Olomouc.
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 2 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: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039998, which also lists 11 linked publications.
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 1 Feb 2017.