Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by American University of Beirut Medical Center
Sponsor:
Collaborator:
PneumoADIP
Information provided by (Responsible Party):
Dr. Ghassan Dbaibo, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00901602
First received: May 8, 2009
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition
Pneumonia
Meningitis
Sepsis
Bacteremia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • Serotype prevalence of S. pneumoniae in invasive pneumococcal disease [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes [ Time Frame: yearly ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Bacterial isolates


Estimated Enrollment: 300
Study Start Date: October 2004
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901602

Contacts
Contact: Ghassan S Dbaibo, M.D. +961-1-749235 ext 5440 gdbaibo@aub.edu.lb
Contact: Carelle Tabet, RN +961-3-860129 cnt@aub.edu.lb

Locations
Lebanon
American University of Beirut Recruiting
Beirut, Lebanon, 113-6044
Contact: Ghassan S Dbaibo, M.D.    +961-1-749235    gdbaibo@aub.edu.lb   
Contact: Carelle Tabet, R.N.    +961-3-860129    cnt03@aub.edu.lb   
Principal Investigator: Ghassan S Dbaibo, M.D.         
Sponsors and Collaborators
American University of Beirut Medical Center
PneumoADIP
Investigators
Principal Investigator: Ghassan S Dbaibo, M.D. American University of Beirut Medical Center
  More Information

No publications provided

Responsible Party: Dr. Ghassan Dbaibo, Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00901602     History of Changes
Other Study ID Numbers: PNEUMOSurv1LIPSP
Study First Received: May 8, 2009
Last Updated: January 31, 2013
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
streptococcus pneumoniae
pneumococcus
pneumonia
meningitis
serotypes
bacteremia
sepsis

Additional relevant MeSH terms:
Bacteremia
Meningitis
Pneumonia
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Infection
Inflammation
Lung Diseases
Nervous System Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014