Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01443793
Status:
UNKNOWN
Last Update Posted:
2011-10-04
First Post:
2011-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Pattern of Streptococcus Pneumoniae Nasopharyngeal Carriage and Antimicrobial Susceptibility in Healthy Children Aged Less Then 5 Years, in the Area of Milan and Surroundings, Lombardy, Italy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'lastUpdateSubmitDate': '2011-10-02', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': '• the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;', 'timeFrame': '1 year'}, {'measure': '• the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;', 'timeFrame': '1 year'}, {'measure': '• the possible impact of vaccination policy in the referenced population', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Streptococcus Pneumoniae Nasopharyngeal Carriage']}, 'descriptionModule': {'briefSummary': 'The objective of this active surveillance study is to make available crucial data about epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility of nasopharyngeal strains of Streptococcus pneumoniae carried in the population of healthy children aged less than years and living in the area of Milan and surroundings, Lombardy, Italy.\n\n* To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy;\n* To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years\n\nSecondary objectives:\n\n* To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;\n* To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;\n* • To evaluate the possible impact of vaccination policy in the referenced population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The sample size is calculated to detect at baseline at least 100 nasopharyngeal swab specimens positive for Streptococcus pneumoniae, and possibly further 100 positive swabs at both 6 and 12 months after recruitment. A probability sample of at least 1,300 children will be recruited. Children will be selected using a randomization list of assisted children less than 5 years-old that will be computer generated for any of participant Family Pediatrician, based on the Lombardy Regional Health Databases and using the National Insurance Number.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy;\n* To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than5 years\n\nExclusion Criteria:\n\n* To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;\n* To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;\n* To evaluate the possible impact of vaccination policy in the referenced population..'}, 'identificationModule': {'nctId': 'NCT01443793', 'briefTitle': 'Longitudinal Pattern of Streptococcus Pneumoniae Nasopharyngeal Carriage and Antimicrobial Susceptibility in Healthy Children Aged Less Then 5 Years, in the Area of Milan and Surroundings, Lombardy, Italy.', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Longitudinal Pattern of Streptococcus Pneumoniae Nasopharyngeal Carriage and Antimicrobial Susceptibility in Healthy Children Aged Less Then 5 Years, in the Area of Milan and Surroundings, Lombardy, Italy.', 'orgStudyIdInfo': {'id': 'Pneumo01'}}, 'contactsLocationsModule': {'locations': [{'zip': '20157', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'role': 'CONTACT', 'phone': '00390239042253'}, {'name': 'Gian Vincenzo Zuccotti, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AO L.Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Gian Vincenzo Zuccotti, Professor', 'role': 'CONTACT', 'email': 'gianvincenzo.zuccotti@unimi.it', 'phone': '00390239042253'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of Pediatrics', 'investigatorFullName': 'Gian Vincenzo Zuccotti', 'investigatorAffiliation': 'University of Milan'}}}}