Streptococcus Pneumoniae Nasopharyngeal CarriageNCT01443793
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 of Streptococcus Pneumoniae Nasopharyngeal Carriage, run by University of Milan at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Streptococcus Pneumoniae Nasopharyngeal Carriage
- How many people
- 1,300 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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..
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AO L.Sacco
Milan, Italy, 20157
00390239042253
Gian Vincenzo Zuccotti, Professor
About this study
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
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
• circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years
Measured: 1 year
Secondary outcomes (3)
• the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;
Measured: 1 year
• the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;
Measured: 1 year
• the possible impact of vaccination policy in the referenced population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Pneumoniae Nasopharyngeal CarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Vincenzo Zuccotti, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443793
- Sponsor's protocol ID
- Pneumo01
- Status last verified
- Oct 2011
- First submitted
- 28 Sep 2011
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01443793
- Acronym / sponsor ID
- Pneumo01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Sep 2011
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years
Time frame: 1 year
3 secondary outcomes
• the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;
Time frame: 1 year
• the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;
Time frame: 1 year
• the possible impact of vaccination policy in the referenced population
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae Nasopharyngeal Carriage, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gian Vincenzo Zuccotti, Professor (00390239042253, gianvincenzo.zuccotti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.