Ventilator Associated PneumoniaNCT00484588
A Multi-Center Observational Surveillance Study of VAP Causing Bacteria
An observational study of Ventilator Associated Pneumonia, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilator Associated Pneumonia
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients hospitalized and mechanically ventilated for more than 48 hours are eligible for the study.
- Fever > 38.3ºC or hypothermia < 36ºC or WBC count > 10,000/mm3.
- Presence of a new or persistent lung opacity on chest radiographs.
- Willing to provide informed legal consent. If the patient is a minor or incapacitated, legal consent may be given by a legal guardian or representative.
- Exclustion:
- Patients whose antibiotic strategy had been changed during the 3 days preceding the diagnostic procedure will not be included.
Who cannot join
None listed.
About this study
Official title: A Multi-Center Observational Surveillance of VAP Causing Bacteria Study
Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method.
Read the detailed description
Any patient admitted into the chosen ICU will be a potential patient for this study. One of the main purposes of this study is to discover the various types of bacteria that cause VAP, and their frequency of occurrence. In order to obtain accurate and applicable results, as many subjects should be tested as possible. Approximately 500 patients will be included in this study.
VAP is defined as any lower respiratory tract infection that developed after 2 day of MV.
The criteria for clinical suspicion of pneumonia are as follows:
Presence of a new or persistent lung opacity on chest radiographs, plus two of the following items:
- Fever > 38.3ºC or hypothermia < 36ºC;
- WBC count > 10,000/mm3 or < 5,000/mm3, and/or purulent endoctracheal aspirate;
- Purulent endotracheal aspirate.
Every patient suspected of having pneumonia will undergo fiberoptic bronchoscopy to obtain samples by means of a bronchoalveolar lavage (BAL). VAP will be diagnosed based on results of BAL where BAL cultures yielding > 104 cfu/ml.
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startMay 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484588
- Sponsor's protocol ID
- 0918X-101828
- Status last verified
- Jun 2007
- First submitted
- 8 Jun 2007
- Last updated
- 11 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Observational Surveillance of VAP Causing Bacteria Study
- ClinicalTrials.gov ID
- NCT00484588
- Acronym / sponsor ID
- 0918X-101828
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- VAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Dec 2006
- First posted
- 11 Jun 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.
Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method.
Detailed description
Any patient admitted into the chosen ICU will be a potential patient for this study. One of the main purposes of this study is to discover the various types of bacteria that cause VAP, and their frequency of occurrence. In order to obtain accurate and applicable results, as many subjects should be tested as possible. Approximately 500 patients will be included in this study.
VAP is defined as any lower respiratory tract infection that developed after 2 day of MV.
The criteria for clinical suspicion of pneumonia are as follows:
Presence of a new or persistent lung opacity on chest radiographs, plus two of the following items:
- Fever > 38.3ºC or hypothermia < 36ºC;
- WBC count > 10,000/mm3 or < 5,000/mm3, and/or purulent endoctracheal aspirate;
- Purulent endotracheal aspirate.
Every patient suspected of having pneumonia will undergo fiberoptic bronchoscopy to obtain samples by means of a bronchoalveolar lavage (BAL). VAP will be diagnosed based on results of BAL where BAL cultures yielding > 104 cfu/ml.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients hospitalized and mechanically ventilated for more than 48 hours are eligible for the study.
- Fever > 38.3ºC or hypothermia < 36ºC or WBC count > 10,000/mm3.
- Presence of a new or persistent lung opacity on chest radiographs.
- Willing to provide informed legal consent. If the patient is a minor or incapacitated, legal consent may be given by a legal guardian or representative.
- Patients whose antibiotic strategy had been changed during the 3 days preceding the diagnostic procedure will not be included.
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 11 Jun 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 6 inclusion and 0 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 11 Jun 2007. 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.
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 11 Jun 2007.