Streptococcus Pneumoniae Nasopharyngeal Carriage

Streptococcus Pneumoniae Nasopharyngeal Carriage Among Children Attending Day-care Centres in the Alpes Maritimes. Substudy: Enterobacterial Intestinal Carriage and Susceptibility to 3rd Generation Cephalosporins

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.

Study Overview

• Status: Completed
• Conditions: Nursery
• Intervention / Treatment: Procedure: Nasopharyngeal (NP) aspirate

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • Hôpital Archet 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• parents refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NP children; Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs	Procedure: Nasopharyngeal (NP) aspirate; Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	one day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Department of Clinical Research and Innovation
• Investigators: Principal Investigator: Christian PRADIER, PU-PH, Centre Hospitalier Universitaire de Nice

Publications and helpful links

General Publications

• Blanc V, Leflon-Guibout V, Blanco J, Haenni M, Madec JY, Rafignon G, Bruno P, Mora A, Lopez C, Dahbi G, Dunais B, Anastay M, Branger C, Moreau R, Pradier C, Nicolas-Chanoine MH. Prevalence of day-care centre children (France) with faecal CTX-M-producing Escherichia coli comprising O25b:H4 and O16:H5 ST131 strains. J Antimicrob Chemother. 2014 May;69(5):1231-7. doi: 10.1093/jac/dkt519. Epub 2014 Jan 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): March 18, 2013
• Study Completion (Actual): March 18, 2014

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimated): December 5, 2011

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal
• Other Study ID Numbers: 11-APN-01