PneumoniaLIPSPNCT00901602
Lebanese Interhospital Pneumococcal Surveillance Program
An observational study of Pneumonia and Meningitis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Pneumonia, Meningitis, Sepsis
- How many people
- 700 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2005to Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with invasive pneumococcal disease with positive culture of S. pneumoniae from a normally sterile site (blood, CSF, etc.)
Who may be able to join
- 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
Who cannot join
- non S. pneumoniae isolates
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut
Beirut, 113-6044
Ghassan S Dbaibo, M.D., +961-1-749235, gdbaibo@aub.edu.lb
Carelle Tabet, R.N., +961-3-860129, cnt03@aub.edu.lb
About this study
Official title: 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.
- Conditions
- Pneumonia, Meningitis, Sepsis, Bacteremia
- Keywords
- streptococcus pneumoniae, pneumococcus, pneumonia, meningitis, serotypes, bacteremia, sepsis
- Medical subject headings
- Pneumonia, Meningitis, Sepsis, Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotype prevalence of S. pneumoniae in invasive pneumococcal disease
Measured: yearly
Secondary outcomes (1)
Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startOct 2005
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- PneumoADIP, Pfizer
- Responsible party
- Principal investigator, Dr. Ghassan Dbaibo, American University of Beirut Medical Center
- Investigators
- Ghassan S Dbaibo, M.D., Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901602
- Sponsor's protocol ID
- PNEUMOSurv1LIPSP
- Acronym
- LIPSP
- Status last verified
- Feb 2023
- First submitted
- 8 May 2009
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)
- ClinicalTrials.gov ID
- NCT00901602
- Acronym / sponsor ID
- LIPSP / PNEUMOSurv1LIPSP
- Conditions
- Pneumonia, Meningitis, Sepsis, Bacteremia
- Keywords
- streptococcus pneumoniae, pneumococcus, pneumonia, meningitis, serotypes, bacteremia, sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- PneumoADIP, Pfizer
- Study start
- Oct 2005
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 14 May 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with invasive pneumococcal disease with positive culture of S. pneumoniae from a normally sterile site (blood, CSF, etc.)
Key inclusion criteria (8 listed)
- Samples included in the study are those that are:
- Acceptable samples include:
Key exclusion criteria (1 listed)
- non S. pneumoniae isolates
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
Serotype prevalence of S. pneumoniae in invasive pneumococcal disease
Time frame: yearly
1 secondary outcome
Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes
Time frame: yearly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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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.
Ghassan S Dbaibo, M.D. principal investigator
American University of Beirut 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 Meningitis, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Feb 2023. 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 Lebanon. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghassan S Dbaibo, M.D. (+961-1-749235 ext. 5440, gdbaibo@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotype prevalence of S. pneumoniae in invasive pneumococcal disease (time frame: yearly). 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 3 Feb 2023.