Ventilator Associated PneumoniaNCT00498121
The Diagnostic and Prognostic Utility of Procalcitonin (ProCT) for Ventilator-associated Pneumonia (VAP)
An observational study of Ventilator Associated Pneumonia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Our aim in this study is to investigate the potential role of serum ProCT as an early diagnostic marker and later prognostic indicator for VAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- PROCALCITONIN LEVEL
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to May 2009
- 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: Patients who are intubated or more than 48 hours
Who may be able to join
- In the preceding 24 h, the appearance of a new opacity or opacities on chest X-ray when compared to previous, and two of the following:
- white blood cell count > 12 or < 5 x 10^9 cells/L,
- temperature > 38°C or < 35°C, or
- purulent secretions.endotracheal samples must be collected by bronchoscope/bronchoalveolar lavage with quantitative culture or endotracheal aspiration with quantitative culture (when available) or qualitative culture from each patient to be enrolled in the study. This is a routine procedure done in every case of suspected VAP and is considered to be the standard of care.
Who cannot join
- Known underlying chronic inflammatory condition of the lung (e.g., sarcoidosis, vasculitis)
- Thyroid cancer patients
- neutropenia (neutrophils < 0.5 x 10^9 cells/L
- Concomitant AIDS
- Solid organ transplantation with severe immunosuppression
- New Antibiotic use for more than 18 hrs before blood sample collection
- Severe pancreatitis
- Attending physician does not agree with enrollment into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Our aim in this study is to investigate the potential role of serum ProCT as an early diagnostic marker and later prognostic indicator for VAP.
Read the detailed description
Ventilator-associated pneumonia (VAP), a bacterial infection that develops after 48 hours or more of intubation, is associated with high morbidity and mortality. Rapid identification of VAP is required to improve survival and to reduce avoidable treatment-associated side effects. Procalcitonin (ProCT), a blood test, is a reasonably specific marker of bacterial infection and its level increases early in sepsis. In this study, a ProCT serum level will be measured in 50 patients with clinically suspected VAP. We aim to show that the ProCT level will be high early in VAP and will stay high in patients with poor prognosis. This will help to address the potential role of ProCT as part of early diagnosis and management of VAP.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- PROCALCITONIN LEVEL
- Keywords
- Ventilator associated pneumonia., Procalcitonin.
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCALCITONIN LEVELDevice
measuring PROCALCITONIN LEVEL
| Study group | Role | What they receive |
|---|---|---|
| VAP patient | Not described Receives: Device: PROCALCITONIN LEVEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT
Measured: Retrospective chart review after results are available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJul 2007
- Study completionMay 2009
Why it stopped: One of the principal investigators has moved to a different institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Salman A Qureshi, MD,FRCPSC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498121
- Sponsor's protocol ID
- BMA-07-001 (mbasi100)
- Status last verified
- Dec 2009
- First submitted
- 6 Jul 2007
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duflo F, Debon R, Monneret G, Bienvenu J, Chassard D, Allaouchiche B. Alveolar and serum procalcitonin: diagnostic and prognostic value in ventilator-associated pneumonia. Anesthesiology. 2002 Jan;96(1):74-9. doi: 10.1097/00000542-200201000-00018.
PubMed 11753005
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic and Prognostic Utility of Procalcitonin (ProCT) for Ventilator-associated Pneumonia (VAP)
- ClinicalTrials.gov ID
- NCT00498121
- Acronym / sponsor ID
- BMA-07-001 (mbasi100)
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Ventilator associated pneumonia., Procalcitonin.
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: One of the principal investigators has moved to a different institution
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- May 2009 (actual)
- First posted
- 9 Jul 2007 (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.
Our aim in this study is to investigate the potential role of serum ProCT as an early diagnostic marker and later prognostic indicator for VAP.
Detailed description
Ventilator-associated pneumonia (VAP), a bacterial infection that develops after 48 hours or more of intubation, is associated with high morbidity and mortality. Rapid identification of VAP is required to improve survival and to reduce avoidable treatment-associated side effects. Procalcitonin (ProCT), a blood test, is a reasonably specific marker of bacterial infection and its level increases early in sepsis. In this study, a ProCT serum level will be measured in 50 patients with clinically suspected VAP. We aim to show that the ProCT level will be high early in VAP and will stay high in patients with poor prognosis. This will help to address the potential role of ProCT as part of early diagnosis and management of VAP.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAP patient | – | Device: PROCALCITONIN LEVEL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are intubated or more than 48 hours
Key inclusion criteria (4 listed)
- In the preceding 24 h, the appearance of a new opacity or opacities on chest X-ray when compared to previous, and two of the following:
- white blood cell count > 12 or < 5 x 10^9 cells/L,
- temperature > 38°C or < 35°C, or
- purulent secretions.endotracheal samples must be collected by bronchoscope/bronchoalveolar lavage with quantitative culture or endotracheal aspiration with quantitative culture (when available) or qualitative culture from each patient to be enrolled in the study. This is a routine procedure done in every case of suspected VAP and is considered to be the standard of care.
Key exclusion criteria (8 listed)
- Known underlying chronic inflammatory condition of the lung (e.g., sarcoidosis, vasculitis)
- Thyroid cancer patients
- neutropenia (neutrophils < 0.5 x 10^9 cells/L
- Concomitant AIDS
- Solid organ transplantation with severe immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROCALCITONIN LEVELmeasuring PROCALCITONIN LEVEL | Device | VAP patient |
Primary outcome
Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT
Time frame: Retrospective chart review after results are available
Results and safety
The study was stopped early (reason given: One of the principal investigators has moved to a different institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2009.
- Background: PubMed 11753005Duflo F, Debon R, Monneret G, Bienvenu J, Chassard D, Allaouchiche B. Alveolar and serum procalcitonin: diagnostic and prognostic value in ventilator-associated pneumonia. Anesthesiology. 2002 Jan;96(1):74-9. doi: 10.1097/00000542-200201000-00018.
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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.
Salman A Qureshi, MD,FRCPSC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
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 Ventilator Associated Pneumonia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Dec 2009. 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 Canada. 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?
The study was stopped early (reason given: One of the principal investigators has moved to a different institution). Results are not available in the source record.
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?
Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT (time frame: Retrospective chart review after results are available). 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 NCT00498121, which also lists 1 linked publication.
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 18 Dec 2009.