Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00428051
Status:
TERMINATED
Last Update Posted:
2011-10-27
First Post:
2007-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colombia Epidemiologic Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}], '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': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32867}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-26', 'studyFirstSubmitDate': '2007-01-25', 'studyFirstSubmitQcDate': '2007-01-26', 'lastUpdatePostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual age specific incidence rate of invasive pneumococcal disease based on the number of identified cases from the study sites and the size of the population at risk for children 28 days to 36 months of age', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epidemiology', 'Surveillance', 'Streptococcal Pneumonia'], 'conditions': ['Pneumonia', 'Meningitis', 'Bacteremia', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '22484295', 'type': 'DERIVED', 'citation': 'Benavides JA, Ovalle OO, Salvador GR, Gray S, Isaacman D, Rodgers GL. Population-based surveillance for invasive pneumococcal disease and pneumonia in infants and young children in Bogota, Colombia. Vaccine. 2012 Aug 31;30(40):5886-92. doi: 10.1016/j.vaccine.2012.03.054. Epub 2012 Apr 4.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0887X1-900&StudyName=Colombia%20Epidemiologic%20Surveillance%20Study', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.', 'detailedDescription': 'The study was stopped based on a decision to include PCV 10 in the National Immunization Program in Colombia. The study was designed to measure the impact of PCV 7 and 13 and is no longer feasible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '28 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Epidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 28 days to 36 months of age\n* Presenting to a participating facility with a measured temperature of 39 degrees C or higher within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, bacteremia, sepsis, or other invasive pneumococcal disease\n\nExclusion Criteria:\n\n* Any patient hat based on the clinical impression of the treating physician should not participate in the study: examples such as those with suspected dengue or urinary tract infection'}, 'identificationModule': {'nctId': 'NCT00428051', 'acronym': 'LEAP II', 'briefTitle': 'Colombia Epidemiologic Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease', 'orgStudyIdInfo': {'id': '0887X1-900'}, 'secondaryIdInfos': [{'id': 'B1841004'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All eligible patients', 'interventionNames': ['Other: Surveillance']}], 'interventions': [{'name': 'Surveillance', 'type': 'OTHER', 'description': 'No study drug, only interventions are blood draws and Chest X-rays', 'armGroupLabels': ['All eligible patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '074065-050', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '607-1159', 'city': 'Uruca', 'state': 'Provincia de San José', 'country': 'Costa Rica', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 9.94775, 'lon': -84.09576}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}