Community Acquired PneumoniaNCT00390819
Epidemiology of Community Acquired Pneumonia in North Israel
An observational study of Community Acquired Pneumonia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality and is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2006to not given
- 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
Who may be able to join
- Community acquired pneumonia
- Hospitalization
Who cannot join
- Immunocompromised patients
- Patients under chemotherapy treatment
- Patients under steroids treament
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ha'Emek Medical Center
Afula, 18101
Fahmi Shibli, M.D., 972-4-6494000 ext. 4347, fahmi_shibli@yahoo.ie
Raul Raz, M.D.
About this study
Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality and is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. The high frequency of respiratory infections and the excessive use of antimicrobials are major contributors to the development of pathogens resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically, without identification of causing pathogen.
Aim of study: To identify common pathogens causing CAP in hospitalized patients in north Israel.
Read the detailed description
Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality.
CAP is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. The high frequency of respiratory infections and the excessive use of antimicrobials are major contributors to the development of pathogens resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically, without identification of causing pathogen.
CAP is divided to two principal groups: Bacterial CAP and Atypical CAP. Since pathogens are different, treatment approach is also different. The main obstacle is absence of adequate diagnostic immediate and cheap tools to enable identifying pathogen and hence treatment is not always appropriate. Giving the right therapy at the right time is of major importance since early start of correct treatment is linked to morbidity and mortality of patients. For prescribing appropriate empiric therapy, knowing the epidemiology of CAP, i.e. the frequent causing pathogens according to age groups and other demographic characteristics, is essential.
Unfortunately, except one study conducted 10 years ago by Dr. Liberman from Soroka Medical Center, there is no characteristic information regarding causing pathogens. Lacking this data, might result in selecting inadequate treatment.
Material \& Methods:
We should enroll about 300 patients hospitalized in Ha'Emek Medical Center with the diagnosis of CAP, in order to make the study results statistically significant.
In addition to demographic and clinical data, following tests will be performed:
- Blood cultures
- Sputum
- PCR - throat culture to the following pathogens:
- Mycoplasma pneumoniae
- Chlamydia pneumoniae
- Legionella
- Adenovirus
- Influenza A
- Influenza B
- RSV
- Metapneumovirus
- Parainfluenza
- Pneumococcal antigen in urine
- Conditions
- Community Acquired Pneumonia
- Keywords
- Community acquired pneumonia
- Medical subject headings
- 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 posted20 Oct 2006 (estimated)
- Study startNov 2006
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 Community 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Fahmi Shibli, M.D., Principal investigator, Ha'Emek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390819
- Sponsor's protocol ID
- 131074
- Status last verified
- Oct 2006
- First submitted
- 19 Oct 2006
- Last updated
- 20 Oct 2006
- Results posted
- No
Publications
Porath A, Schlaeffer F, Lieberman D. The epidemiology of community-acquired pneumonia among hospitalized adults. J Infect. 1997 Jan;34(1):41-8. doi: 10.1016/s0163-4453(97)80008-4.
PubMed 9120323
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Community Acquired Pneumonia in North Israel
- ClinicalTrials.gov ID
- NCT00390819
- Acronym / sponsor ID
- 131074
- Conditions
- Community Acquired Pneumonia
- Keywords
- Community acquired pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2006
- First posted
- 20 Oct 2006 (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.
Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality and is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. The high frequency of respiratory infections and the excessive use of antimicrobials are major contributors to the development of pathogens resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically, without identification of causing pathogen.
Aim of study: To identify common pathogens causing CAP in hospitalized patients in north Israel.
Detailed description
Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality.
CAP is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. The high frequency of respiratory infections and the excessive use of antimicrobials are major contributors to the development of pathogens resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically, without identification of causing pathogen.
CAP is divided to two principal groups: Bacterial CAP and Atypical CAP. Since pathogens are different, treatment approach is also different. The main obstacle is absence of adequate diagnostic immediate and cheap tools to enable identifying pathogen and hence treatment is not always appropriate. Giving the right therapy at the right time is of major importance since early start of correct treatment is linked to morbidity and mortality of patients. For prescribing appropriate empiric therapy, knowing the epidemiology of CAP, i.e. the frequent causing pathogens according to age groups and other demographic characteristics, is essential.
Unfortunately, except one study conducted 10 years ago by Dr. Liberman from Soroka Medical Center, there is no characteristic information regarding causing pathogens. Lacking this data, might result in selecting inadequate treatment.
Material \& Methods:
We should enroll about 300 patients hospitalized in Ha'Emek Medical Center with the diagnosis of CAP, in order to make the study results statistically significant.
In addition to demographic and clinical data, following tests will be performed:
- Blood cultures
- Sputum
- PCR - throat culture to the following pathogens:
- Mycoplasma pneumoniae
- Chlamydia pneumoniae
- Legionella
- Adenovirus
- Influenza A
- Influenza B
- RSV
- Metapneumovirus
- Parainfluenza
- Pneumococcal antigen in urine
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Community acquired pneumonia
- Hospitalization
Key exclusion criteria (3 listed)
- Immunocompromised patients
- Patients under chemotherapy treatment
- Patients under steroids treament
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2006.
- Background: PubMed 9120323Porath A, Schlaeffer F, Lieberman D. The epidemiology of community-acquired pneumonia among hospitalized adults. J Infect. 1997 Jan;34(1):41-8. doi: 10.1016/s0163-4453(97)80008-4.
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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.
Fahmi Shibli, M.D. principal investigator
Ha'Emek Medical Center, Afula, Israel
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 Community Acquired Pneumonia, run by HaEmek Medical Center, Israel 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Oct 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahmi Shibli, M.D. (972-4-6494000 ext. 4347, fahmi_shibli@yahoo.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390819, 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 20 Oct 2006.