CClinicalTrials.gg
Status unknownNCT01443793Updated Oct 4, 2011

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.

An observational study in Streptococcus Pneumoniae Nasopharyngeal Carriage, sponsored by University of Milan. Status unknown at 1 site in Italy. Open to participants aged 3 Months to 5 Years. Per ClinicalTrials.gov, last updated 2011-10-04.

Sponsored by University of Milan · Observational

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,300
Ages
3 Months to 5 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Streptococcus Pneumoniae Nasopharyngeal Carriage
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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..
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,300 participants (estimated)
06

What researchers measure

Primary outcomes

  1. • circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years

    Time frame: 1 year

Secondary outcomes

  1. • the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;

    Time frame: 1 year

  2. • the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;

    Time frame: 1 year

  3. • the possible impact of vaccination policy in the referenced population

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • AO L.Sacco
    Milano, 20157, Italy
    • · Contact · 00390239042253
    • Gian Vincenzo Zuccotti, Professor · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01443793
Lead sponsor
University of Milan
Responsible party
Gian Vincenzo Zuccotti (professor of Pediatrics, University of Milan) — Principal investigator
First posted
Sep 30, 2011
Start date
Sep 2011
Last update
Oct 4, 2011

Study contacts

Gian Vincenzo Zuccotti, Professor
Contact
gianvincenzo.zuccotti@unimi.it
00390239042253

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion