Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-13 @ 1:40 AM
Study NCT ID:
NCT00901602
Status:
RECRUITING
Last Update Posted:
2023-02-03
First Post:
2009-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lebanese Interhospital Pneumococcal Surveillance Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bacterial isolates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2009-05-08', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serotype prevalence of S. pneumoniae in invasive pneumococcal disease', 'timeFrame': 'yearly'}], 'secondaryOutcomes': [{'measure': 'Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes', 'timeFrame': 'yearly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['streptococcus pneumoniae', 'pneumococcus', 'pneumonia', 'meningitis', 'serotypes', 'bacteremia', 'sepsis'], 'conditions': ['Pneumonia', 'Meningitis', 'Sepsis', 'Bacteremia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with invasive pneumococcal disease with positive culture of S. pneumoniae from a normally sterile site (blood, CSF, etc.)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Samples included in the study are those that are:\n\n * culture proven\n * invasive pneumococcal infections\n * in patients of all ages admitted to different hospitals all over Lebanon\n* Acceptable samples include:\n\n * positive isolates from blood\n * cerebrospinal fluid\n * 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\n\nExclusion Criteria:\n\n* non S. pneumoniae isolates'}, 'identificationModule': {'nctId': 'NCT00901602', 'acronym': 'LIPSP', 'briefTitle': 'Lebanese Interhospital Pneumococcal Surveillance Program', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)', 'orgStudyIdInfo': {'id': 'PNEUMOSurv1LIPSP'}}, 'contactsLocationsModule': {'locations': [{'zip': '113-6044', 'city': 'Beirut', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Ghassan S Dbaibo, M.D.', 'role': 'CONTACT', 'email': 'gdbaibo@aub.edu.lb', 'phone': '+961-1-749235'}, {'name': 'Carelle Tabet, R.N.', 'role': 'CONTACT', 'email': 'cnt03@aub.edu.lb', 'phone': '+961-3-860129'}, {'name': 'Ghassan S Dbaibo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'American University of Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'Ghassan S Dbaibo, M.D.', 'role': 'CONTACT', 'email': 'gdbaibo@aub.edu.lb', 'phone': '+961-1-749235', 'phoneExt': '5440'}, {'name': 'Mireille Lteif, RN', 'role': 'CONTACT', 'email': 'ml12@aub.edu.lb', 'phone': '+961-1-350000', 'phoneExt': '5752'}], 'overallOfficials': [{'name': 'Ghassan S Dbaibo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'PneumoADIP', 'class': 'UNKNOWN'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Ghassan Dbaibo', 'investigatorAffiliation': 'American University of Beirut Medical Center'}}}}