PneumoniaNCT01178580
Procoagulant Activity in Patients With Community Acquired Pneumonia, Pleural Effusion and Empyema
An observational study of Pneumonia and Pleural Effusion, run by Meir Medical Center at 1 site in Israel.
Trial summary
Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pleural Effusion, Empyema
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to Aug 2011
- 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: all patients that will be admitted with CAP to the pulmonary department in Meir Medical Center and have no exclusion criteria will be included in the study
Who may be able to join
- All patients that will be admitted with CAP to the pulmonary department in Meir Medical Center and have no exclusion criteria will be included in the study.
Who cannot join
- Patients younger than 18 years old
- Patients with anticoagulant treatment, primary coagulopathy, nephrotic syndrome, surgery, other infection in the month preceding the study, an abnormal liver or renal function test(s), a history of deep vein thrombosis in the last year or patients with acute coronary syndrome.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pulmonary department, Meir Medical Center
Kfar Saba, Israel, 49100
About this study
Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis.
The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.
Read the detailed description
Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis. (2) The increased vascular permeability, mediated by several cytokines, such as IL-1, IL-6, IL-8, tumor necrosis factor (TNF), and platelet activator factor, allows migration of inflammatory cells, an increased fluid accumulation and bacterial invasion into pleural space. (3) At this stage, activation of the coagulation cascade leads to procoagulant activity and decreased fibrinolysis with deposition of fibrin in the pleural space. The activation of the fibrinolytic system produce the D-dimer and follow by increased other procoagulant markers like thrombin anti thrombin, fragment 1.2 (4-5) Several studies showed that the plasma D-dimer levels were increased even in community-acquired pneumonia patients. Moreover, others reported that Serum levels of AT-III, D-D and CRP at admission appear to be useful biomarkers for assessing the severity of CAP. However, no data exists about the fibrinolytic profile in patients with CAP alone in compare to CAP with parapneumonic effusion with and without empyema.
Aim:
To study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.
- Conditions
- Pneumonia, Pleural Effusion, Empyema
- Keywords
- fibrinolytic activity, Community acquired pneumonia (CAP), Pleural effusion
- Medical subject headings
- Pneumonia, Pleural Effusion, Empyema, Community-Acquired Pneumonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionAug 2011
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Shitrit, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178580
- Sponsor's protocol ID
- MMC10-138-10.CTIL
- Status last verified
- Sep 2011
- First submitted
- 8 Aug 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procoagulant Activity in Patients With Community Acquired Pneumonia, Pleural Effusion and Empyema
- ClinicalTrials.gov ID
- NCT01178580
- Acronym / sponsor ID
- MMC10-138-10.CTIL
- Conditions
- Pneumonia, Pleural Effusion, Empyema
- Keywords
- fibrinolytic activity, Community acquired pneumonia (CAP), Pleural effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Aug 2010 (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.
Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis.
The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.
Detailed description
Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis. (2) The increased vascular permeability, mediated by several cytokines, such as IL-1, IL-6, IL-8, tumor necrosis factor (TNF), and platelet activator factor, allows migration of inflammatory cells, an increased fluid accumulation and bacterial invasion into pleural space. (3) At this stage, activation of the coagulation cascade leads to procoagulant activity and decreased fibrinolysis with deposition of fibrin in the pleural space. The activation of the fibrinolytic system produce the D-dimer and follow by increased other procoagulant markers like thrombin anti thrombin, fragment 1.2 (4-5) Several studies showed that the plasma D-dimer levels were increased even in community-acquired pneumonia patients. Moreover, others reported that Serum levels of AT-III, D-D and CRP at admission appear to be useful biomarkers for assessing the severity of CAP. However, no data exists about the fibrinolytic profile in patients with CAP alone in compare to CAP with parapneumonic effusion with and without empyema.
Aim:
To study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.
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
- all patients that will be admitted with CAP to the pulmonary department in Meir Medical Center and have no exclusion criteria will be included in the study
Key inclusion criteria (1 listed)
- All patients that will be admitted with CAP to the pulmonary department in Meir Medical Center and have no exclusion criteria will be included in the study.
Key exclusion criteria (2 listed)
- Patients younger than 18 years old
- Patients with anticoagulant treatment, primary coagulopathy, nephrotic syndrome, surgery, other infection in the month preceding the study, an abnormal liver or renal function test(s), a history of deep vein thrombosis in the last year or patients with acute coronary syndrome.
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 7 Sep 2011.
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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.
David Shitrit, MD principal investigator
Meir Medical Center
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 and Pleural Effusion, run by Meir Medical Center at 1 site in Israel.
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 2 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 7 Sep 2011. 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 Israel. 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.
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 7 Sep 2011.