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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00390819
Other study ID # 131074
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 19, 2006
Last updated October 19, 2006
Start date November 2006

Study information

Verified date October 2006
Source HaEmek Medical Center, Israel
Contact Fahmi Shibli, M.D.
Phone 972-4-6494000
Email fahmi_shibli@yahoo.ie
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical 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. 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.


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:

1. Blood cultures

2. Sputum

3. PCR - throat culture to the following pathogens:

- Mycoplasma pneumoniae

- Chlamydia pneumoniae

- Legionella

- Adenovirus

- Influenza A

- Influenza B

- RSV

- Metapneumovirus

- Parainfluenza

- Pneumococcal antigen in urine


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Community acquired pneumonia

- Hospitalization

Exclusion Criteria:

- Immunocompromised patients

- Patients under chemotherapy treatment

- Patients under steroids treament

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Ha'Emek Medical Center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Porath A, Schlaeffer F, Lieberman D. The epidemiology of community-acquired pneumonia among hospitalized adults. J Infect. 1997 Jan;34(1):41-8. — View Citation

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