- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901602
Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)
January 31, 2013 updated by: Dr. Ghassan Dbaibo, American University of Beirut Medical Center
Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)
Streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in children and adults such as meningitis, pneumonia, and blood stream infection.
There are many types of these bacteria defined by the type of sugar coat that they have.
These are classified as serotypes.
There are common serotypes that cause severe disease and are preventable by vaccination of children.
Other less common types are more difficult to prevent.
The investigators aim to determine the serotypes that cause invasive pneumococcal disease in Lebanon and to study their sensitivity to different antibiotics.
The investigators will collect bacterial isolates from different hospitals in Lebanon isolated from the blood or spinal fluid of patients with invasive pneumococcal disease.
This information will help the investigators determine the usefulness of available pneumococcal vaccines in preventing these infections.
The data will be distributed to all primary care physicians treating children in Lebanon and will be shared with the Ministry of Health.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ghassan S Dbaibo, M.D.
- Phone Number: 5440 +961-1-749235
- Email: gdbaibo@aub.edu.lb
Study Contact Backup
- Name: Carelle Tabet, RN
- Phone Number: +961-3-860129
- Email: cnt@aub.edu.lb
Study Locations
-
-
-
Beirut, Lebanon, 113-6044
- Recruiting
- American University of Beirut
-
Contact:
- Ghassan S Dbaibo, M.D.
- Phone Number: +961-1-749235
- Email: gdbaibo@aub.edu.lb
-
Contact:
- Carelle Tabet, R.N.
- Phone Number: +961-3-860129
- Email: cnt03@aub.edu.lb
-
Principal Investigator:
- Ghassan S Dbaibo, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with invasive pneumococcal disease with positive culture of S. pneumoniae from a normally sterile site (blood, CSF, etc.)
Description
Inclusion Criteria:
Samples included in the study are those that are:
- culture proven
- invasive pneumococcal infections
- in patients of all ages admitted to different hospitals all over Lebanon
Acceptable samples include:
- positive isolates from blood
- cerebrospinal fluid
- other normally sterile body sites such as empyema fluid, abscesses, joint fluid, middle ear fluid obtained by tympanocentesis in the operating room, and lung needle aspiration
Exclusion Criteria:
- non S. pneumoniae isolates
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serotype prevalence of S. pneumoniae in invasive pneumococcal disease
Time Frame: yearly
|
yearly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes
Time Frame: yearly
|
yearly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ghassan S Dbaibo, M.D., American University of Beirut Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
May 8, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (Estimate)
May 14, 2009
Study Record Updates
Last Update Posted (Estimate)
February 1, 2013
Last Update Submitted That Met QC Criteria
January 31, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Bacterial Infections
- Bacterial Infections and Mycoses
- Sepsis
- Pneumonia
- Bacteremia
- Meningitis
Other Study ID Numbers
- PNEUMOSurv1LIPSP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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