Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05114902
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2021-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The retained specimen will consist of isolates of Streptococcus pneumoniae cultured from the nasopharyngeal swab.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'S. pneumoniae serotypes', 'timeFrame': 'Upon Admission', 'description': 'S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)'}, {'measure': 'S. pneumoniae serotypes Upon Admission', 'timeFrame': 'Upon Admission', 'description': 'S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC)'}, {'measure': 'Antimicrobial resistance rate of S. pneumoniae', 'timeFrame': 'Upon Admission', 'description': 'Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13- unvaccinated site (PCMC)'}, {'measure': 'Antimicrobial resistance rate of S. pneumoniae', 'timeFrame': 'Upon Admission', 'description': 'Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13-vaccinated site (SPMC)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical CAP'], 'conditions': ['Community-acquired Pneumonia']}, 'descriptionModule': {'briefSummary': 'Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP).', 'detailedDescription': 'This study will be the first of two phases (A and B). Phase A will compare a PCV13-vaccinated setting (SPMC) with an unvaccinated setting (PCMC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '8 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 8 weeks to ≤60 months of age from the National Capital Region (NCR) or Region X-XIII admitted with a medical diagnosis of clinical community-acquired pneumonia (CAP), confirmed by an abnormal chest x-ray. In Region X-XIII, the child must have received at least 1 dose of PCV13 given at \\<12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Child 8 weeks to ≤60 months of age\n2. Resident of the National Capital Region (NCR) or Region X-XIII\n3. Child admitted with a medical diagnosis of clinical CAP based on history and physical exam\n4. Written informed consent obtained from a parent or legal guardian\n5. At SPMC site, child must have received at least 1 dose of PCV13 given at \\<12 months based on history-taking\n6. For Phase B at PCMC site, child must have received at least 1 dose of PCV13 given at \\<12 months based on history-taking\n\nExclusion Criteria:\n\n1. Children with a known primary or secondary immunodeficiency\n2. Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32\n3. For Phase A at PCMC site, child with any PCV in the past based on history-taking'}, 'identificationModule': {'nctId': 'NCT05114902', 'acronym': 'IMPACT', 'briefTitle': 'PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study', 'organization': {'class': 'OTHER', 'fullName': 'Asian Foundation for Tropical Medicine Inc.'}, 'officialTitle': 'Assessing the Impact of PCV13 on Pneumococcal Nasopharyngeal Colonization in Children 8 Weeks to ≤60 Months of Age Hospitalized for Pneumonia in the Philippines', 'orgStudyIdInfo': {'id': 'CT-44 Study Protocol AFTM-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCV13 Non-vaccinated Settting', 'description': 'Pneumococcal vaccine-naïve children at the PCMC', 'interventionNames': ['Diagnostic Test: Nasopharyngeal swab']}, {'label': 'PCV13 Vaccinated Setting', 'description': 'Pneumococcal vaccine-exposed children at the SPMC', 'interventionNames': ['Diagnostic Test: Nasopharyngeal swab']}], 'interventions': [{'name': 'Nasopharyngeal swab', 'type': 'DIAGNOSTIC_TEST', 'description': 'A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage', 'armGroupLabels': ['PCV13 Non-vaccinated Settting', 'PCV13 Vaccinated Setting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': "Philippine Children's Medical Center", 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}], 'overallOfficials': [{'name': 'Marilla G Lucero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asian Foundation for Tropical Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Foundation for Tropical Medicine Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': "Philippine Children's Medical Center, Philippines", 'class': 'UNKNOWN'}, {'name': 'Southern Philippines Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marilla Lucero', 'investigatorAffiliation': 'Asian Foundation for Tropical Medicine Inc.'}}}}