Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT03696303
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2018-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine Blood Nasopharyngeal swab samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 959}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary antigen detection cut-points for invasive S. pneumoniae disease', 'timeFrame': 'Within 48 hours', 'description': 'To determine Cut-Points to discriminate a positive or negative urine antigen test that differentiates invasive disease versus the carriage state'}], 'secondaryOutcomes': [{'measure': 'Detection of S. pneumoniae serotypes using Urinary antigen detection assay', 'timeFrame': 'Within 48 hours', 'description': 'To determine the sensitivity and specificity of the Luminex xMPA pneumococcal UAD in the identification of S. pneumoniae serotypes (PCV13 serotypes) in children with radiologically confirmed CAP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Streptococcus pneumoniae', 'Pneumonia', 'Community-acquired', 'Pediatric', 'Urine antigen'], 'conditions': ['Community-acquired Pneumonia', 'Streptococcus Pneumoniae Infection']}, 'descriptionModule': {'briefSummary': 'This prospective case-control study aims to evaluate the utility and establish laboratory thresholds for a multi-serotype urine antigen test for the diagnosis of pneumococcal community acquired pneumonia in children 5 years of age or younger in Guatemala.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '31 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).', 'healthyVolunteers': True, 'eligibilityCriteria': 'CASES:\n\nInclusion Criteria:\n\n* Age older than 1 month (31 days) and up to 71 months and 28 days.\n* Diagnosis of radiologically confirmed pneumonia per WHO criteria in the ED or hospital within 48 hours of hospital admission\n* Signed informed consent by parents or legal guardian to participate in the study\n\nExclusion Criteria:\n\n* Known immunodeficiency\n* Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder\n* Significant neurological disorder\n* Hospitalization within the previous 30 days for pneumonia or respiratory infection\n* Use of parenteral antibiotics for current illness (leading to diagnosis of pneumonia)\n* Transferred to the study hospital after already being hospitalized at a different location for ≥ 48 hours\n\nCONTROLS:\n\nInclusion Criteria:\n\n* Age 1 to 71 months and signed informed consent by parents or legal guardian\n\nExclusion Criteria:\n\n* Known immunodeficiency\n* Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder\n* Significant neurological disorder\n* Fever or suspicion of community-acquired pneumonia or other respiratory infectious disease (symptoms of cough, congestion, tachypnea, indrawing, etc.)\n* Hospitalization within the previous 30 days for pneumonia or respiratory infection'}, 'identificationModule': {'nctId': 'NCT03696303', 'briefTitle': "Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala", 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': "Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala", 'orgStudyIdInfo': {'id': '18-0737'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Suspected community-acquired bacterial pneumonia', 'interventionNames': ['Other: Urinary antigen detection assay']}, {'label': 'Controls', 'description': 'Healthy children, age-matched to enrolled cases', 'interventionNames': ['Other: Urinary antigen detection assay']}, {'label': 'Controls with URI', 'description': 'Children 5 years of age or younger with upper respiratory infection (URI) (controls with URI)', 'interventionNames': ['Other: Urinary antigen detection assay']}], 'interventions': [{'name': 'Urinary antigen detection assay', 'type': 'OTHER', 'description': 'Screening for Ag level in S. pneumoniae urinary antigen detection assay.', 'armGroupLabels': ['Cases', 'Controls', 'Controls with URI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cuilapa', 'state': 'Santa Rosa Department', 'country': 'Guatemala', 'facility': 'Hospital Regional Cuilapa', 'geoPoint': {'lat': 14.27537, 'lon': -90.29865}}, {'zip': '01009', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Hospital General IGSS', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01011', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Hospital Roosevelt', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}], 'overallOfficials': [{'name': 'Edwin Asturias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}