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.

October 2, 2011 updated by: Gian Vincenzo Zuccotti, University of Milan

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.

  • 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;
  • To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years

Secondary objectives:

  • To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;
  • To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;
  • • To evaluate the possible impact of vaccination policy in the referenced population.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20157
        • Recruiting
        • AO L.Sacco
        • Contact:
          • Phone Number: 00390239042253
        • Principal Investigator:
          • Gian Vincenzo Zuccotti, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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;
  • To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than5 years

Exclusion Criteria:

  • To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;
  • To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;
  • To evaluate the possible impact of vaccination policy in the referenced population..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
• the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;
Time Frame: 1 year
1 year
• the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;
Time Frame: 1 year
1 year
• the possible impact of vaccination policy in the referenced population
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

October 4, 2011

Last Update Submitted That Met QC Criteria

October 2, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pneumo01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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