PneumoniaNCT00976157
Serial Changes in sTREM-1 During Ventilator-associated Pneumonia (VAP)
An observational study of Pneumonia, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses. The aim of this study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in bronchoalveolar lavage (BAL) fluid of clinically… Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Bronchoscopy BAL
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2006to Sep 2008
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were clinically suspected to have VAP were enrolled in the study. VAP was clinically diagnosed with a new infiltrate on a chest radiograph in a patient receiving mechanical ventilation for more than 48 hr with at least one of the following: purulent tracheal secretions, a body temperature >38°C or <36°C, and leukocytosis (WBC > 10,000/mm³) or leukopenia (WBC < 4000/mm³)
Who may be able to join
- adult patients (older than 18 years)with clinically suspected VAP
Who cannot join
- mechanically ventilated patients post cardiopulmonary resuscitation
- patients with end stage diseases with life expectancy less than 3 months
- patients with solid or hematology transplantation
- patients on immunosuppressive agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Changes of Soluble TREM-1 Level in Bronchoalveolar Lavage Fluid During Ventilator-associated Pneumonia
Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses. The aim of this study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia (VAP) and its correlation with response to treatment and outcome.
Read the detailed description
A prospective, interventional study conducted between August 2006 and August 2007 in MICU in Mackay Memorial Hospital, 35 patients with clinically diagnosed VAP were investigated. sTREM-1 was measured in BAL samples using ELISA at the onset, 4th - 5th and 7th - 9th day of clinical diagnosis of VAP.Of these 35 patients, 27 had positive BAL culture. The sTREM-1 levels in BAL fluid were measured and compared between patients with positive BAL culture and negative BAL culture. Serial changes in sTREM-1 levels were evaluated in relation to patient outcome.
- Conditions
- Pneumonia
- Being tested
- Bronchoscopy BAL
- Keywords
- STREM-1, BAL, VAP
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy BALProcedure or surgery
The bronchoscope was passed through endotracheal tube via a specific adaptor without topical anesthesia. The bronchoscope was introduced and wedged into the segmental bronchial orifice where pneumonia was suspected. Five aliquots of 20ml sterile saline were instilled and aspirated gently. The first aliquot was discarded and the last 4 aliquots were pooled for analysis. Part of the retrieved specimen in the first BAL fluid was sent to the laboratory immediately after collection for measurement of sTREM-1 level, the rest of sample was sent to microbiology lab for quantitative culture.
| Study group | Role | What they receive |
|---|---|---|
| Ventilator-associated pneumonia | Not described Receives: Procedure: Bronchoscopy BAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startAug 2006
- Primary completionDec 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chien Liang Wu, MD, Principal investigator, Mackay Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976157
- Sponsor's protocol ID
- MMH-I-S-201
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Changes of Soluble TREM-1 Level in Bronchoalveolar Lavage Fluid During Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT00976157
- Acronym / sponsor ID
- MMH-I-S-201
- Conditions
- Pneumonia
- Keywords
- STREM-1, BAL, VAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Sep 2009 (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.
Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses. The aim of this study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia (VAP) and its correlation with response to treatment and outcome.
Detailed description
A prospective, interventional study conducted between August 2006 and August 2007 in MICU in Mackay Memorial Hospital, 35 patients with clinically diagnosed VAP were investigated. sTREM-1 was measured in BAL samples using ELISA at the onset, 4th - 5th and 7th - 9th day of clinical diagnosis of VAP.Of these 35 patients, 27 had positive BAL culture. The sTREM-1 levels in BAL fluid were measured and compared between patients with positive BAL culture and negative BAL culture. Serial changes in sTREM-1 levels were evaluated in relation to patient outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilator-associated pneumonia | – | Procedure: Bronchoscopy BAL |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were clinically suspected to have VAP were enrolled in the study. VAP was clinically diagnosed with a new infiltrate on a chest radiograph in a patient receiving mechanical ventilation for more than 48 hr with at least one of the following: purulent tracheal secretions, a body temperature >38°C or <36°C, and leukocytosis (WBC > 10,000/mm³) or leukopenia (WBC < 4000/mm³)
Key inclusion criteria (1 listed)
- adult patients (older than 18 years)with clinically suspected VAP
Key exclusion criteria (4 listed)
- mechanically ventilated patients post cardiopulmonary resuscitation
- patients with end stage diseases with life expectancy less than 3 months
- patients with solid or hematology transplantation
- patients on immunosuppressive agents
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 |
|---|---|---|
| Bronchoscopy BALThe bronchoscope was passed through endotracheal tube via a specific adaptor without topical anesthesia. The bronchoscope was introduced and wedged into the segmental bronchial orifice where pneumonia was suspected. Five aliquots of 20ml sterile saline were instilled and aspirated gently. The first aliquot was discarded and the last 4 aliquots were pooled for analysis. Part of the retrieved specimen in the first BAL fluid was sent to the laboratory immediately after collection for measurement of sTREM-1 level, the rest of sample was sent to microbiology lab for quantitative culture. | Procedure or surgery | Ventilator-associated pneumonia |
Primary outcome
mortality
Time frame: 18 months
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 15 Sep 2009.
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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.
Chien Liang Wu, MD principal investigator
Mackay Memorial Hospital, Taipei, Taiwan
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 Pneumonia, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 15 Sep 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 Taiwan. 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 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?
mortality (time frame: 18 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 15 Sep 2009.