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.

Streptococcus Pneumoniae Nasopharyngeal Carriage Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01443793
• Other study ID #: Pneumo01
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2011
• Last updated: October 2, 2011
• Start date: September 2011

Study information

• Verified date: October 2011
• Source: University of Milan
• Contact: Gian Vincenzo Zuccotti, Professor
• Phone: 00390239042253
• Email: gianvincenzo.zuccotti[@]unimi.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Susceptibility
• Pneumonia
• Streptococcus Pneumoniae Nasopharyngeal Carriage

Locations

Country	Name	City	State
Italy	AO L.Sacco	Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years		1 year	No
Secondary	• the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;		1 year	No
Secondary	• the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;		1 year	No
Secondary	• the possible impact of vaccination policy in the referenced population		1 year	No