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Streptococcus Pneumoniae Nasopharyngeal Carriage

Primary Purpose

Nursery

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasopharyngeal (NP) aspirate
Sponsored by
Department of Clinical Research and Innovation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nursery

Eligibility Criteria

3 Months - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children aged from 3 months to 4 years
  • Attending a day care center
  • Parents give informed consent

Exclusion Criteria:

  • parents refusal

Sites / Locations

  • Hôpital Archet 1Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NP children

Arm Description

Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs

Outcomes

Primary Outcome Measures

Streptococcus pneumoniae nasopharyngeal carriage among children attending day-care centres, and Streptococcus pneumoniae antibiotic susceptibility Substudy: Enterobacterial intestinal carriage and susceptibility to 3rd generation cephalosporins

Secondary Outcome Measures

•Antibiotics prescriptions within the 3 previous months in children's health booklets and in a questionnaire completed by parents
• Immunization status for pneumococcal conjugate vaccine PCV7-type vaccine from children's health books and from day care centres health files
• Pneumococcal serotypes distribution compared to immunization status
• Comparison of the data above with the previous five cross-sectional surveys

Full Information

First Posted
September 23, 2011
Last Updated
December 17, 2012
Sponsor
Department of Clinical Research and Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT01485029
Brief Title
Streptococcus Pneumoniae Nasopharyngeal Carriage
Official Title
Streptococcus Pneumoniae Nasopharyngeal Carriage Among Children Attending Day-care Centres in the Alpes Maritimes. Substudy: Enterobacterial Intestinal Carriage and Susceptibility to 3rd Generation Cephalosporins
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Department of Clinical Research and Innovation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Antibiotic consumption and antimicrobial resistance remain notoriously high in France, particularly among children below three years of age. In France, the pneumococcal conjugate vaccine was officially recommended for all children under two in 2003, and consequently changes occurred in Streptococcus pneumoniae serotype distribution. Bacterial carriage among children attending day-care centres may result from vaccine- and antibiotic-driven selective pressure with possible repercussions on the community.
Detailed Description
Antibiotic consumption and antimicrobial resistance remain notoriously high in France, particularly among children below three years of age. In France, the pneumococcal conjugate vaccine was officially recommended for all children under two in 2003, and consequently changes occurred in Streptococcus pneumoniae serotype distribution. Bacterial carriage among children attending day-care centres may result from vaccine- and antibiotic-driven selective pressure with possible repercussions on the community. To identify prevalence (rates) and trends in antibiotic resistance patterns in Streptococcus pneumoniae (SP) among children attending day-care centres, as well as antibiotic prescriptions and vaccine rates, nasopharyngeal (NP) carriage was monitored, by conducting five cross-sectional surveys from January to March 1999, 2002, 2004, 2006 and 2008 among these children in the area of the Alpes Maritimes, in South-Eastern France. Interventions promoting prudent antibiotic use (PAU) took place in 2000 and since 2003, with temporary effectiveness but national prescription rates are reported to be currently increasing again. A new pneumococcal conjugate vaccine covering more serotypes (13-valent) now replaces the previous one. In this situation, a new cross-sectional survey in day-care centres with the same design may answer the following questions. Increasing antibiotic susceptibility was observed during past successive surveys. Has this trend been sustained to this day? Are antibiotics prescription rates among children attending day-care centres still decreasing, have they stabilized, or are they on the rise again reflecting recently reported national trends? Regarding choice of antimicrobial treatment, are 3rd generation cephalosporin increasingly prescribed rather than aminopenicillins? Is implementation of the new wider spectrum pneumococcal conjugate vaccine exerting changes on serotype distribution and thus on the nasopharyngeal ecosystem of these children? These parameters will be useful to renew, or even reinforce, and adapt professional guidelines and community-oriented messages concerning prudent antibiotic use. Sub-study: Antibiotic-resistant enterobacteriaceae, initially observed in the hospital setting, are currently spreading within the community, especially extended-spectrum beta-lactamase-producing enterobacteriaceae, threatening antibiotic effectiveness in case of infection. Such infections with Enterobacteriaceae, in particular urinary tract infections, can occur among children. Prevalence rates of such carriage among children attending day-care centres is unknown, although they are highly exposed to antibiotics in relation with frequent respiratory tract infections, in particular to 3rd generation cephalosporins. To assess this prevalence rate, faecal samples from children attending day-care centres will be collected during the cross-sectional nasopharyngeal survey quoted above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NP children
Arm Type
Experimental
Arm Description
Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
Intervention Type
Procedure
Intervention Name(s)
Nasopharyngeal (NP) aspirate
Intervention Description
Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
Primary Outcome Measure Information:
Title
Streptococcus pneumoniae nasopharyngeal carriage among children attending day-care centres, and Streptococcus pneumoniae antibiotic susceptibility Substudy: Enterobacterial intestinal carriage and susceptibility to 3rd generation cephalosporins
Time Frame
one day
Secondary Outcome Measure Information:
Title
•Antibiotics prescriptions within the 3 previous months in children's health booklets and in a questionnaire completed by parents
Time Frame
one day
Title
• Immunization status for pneumococcal conjugate vaccine PCV7-type vaccine from children's health books and from day care centres health files
Time Frame
one day
Title
• Pneumococcal serotypes distribution compared to immunization status
Time Frame
one day
Title
• Comparison of the data above with the previous five cross-sectional surveys
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged from 3 months to 4 years Attending a day care center Parents give informed consent Exclusion Criteria: parents refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian PRADIER, PU-PH
Email
pradier.c@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Vanina OLIVERI, ARC
Phone
0033 4 92 03 42 54
Email
oliveri.v@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian PRADIER, PU-PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Archet 1
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale BRUNO, PH
Email
bruno.p@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Vanina OLIVERI, ARC
Phone
0033 4 92 03 42 54
Email
oliveri.v@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Christian PRADIER, PU-PH
First Name & Middle Initial & Last Name & Degree
Pascale BRUNO, PH
First Name & Middle Initial & Last Name & Degree
Brigitte DUNAIS, PH
First Name & Middle Initial & Last Name & Degree
Pia TOUBOUL, PH

12. IPD Sharing Statement

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Streptococcus Pneumoniae Nasopharyngeal Carriage

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