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CompletedNCT01485029Updated Mar 27, 2026

Streptococcus Pneumoniae Nasopharyngeal Carriage

An interventional study of Nasopharyngeal (NP) aspirate in Nursery, sponsored by Department of Clinical Research and Innovation. Completed at 1 site in France. Open to participants aged 3 Months to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Department of Clinical Research and Innovation · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
3 Months to 4 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Nursery
03

In context

Lead sponsor

Department of Clinical Research and Innovation is the lead sponsor of 7 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
3 Months to 4 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • parents refusal
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    NP children

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

    Procedure: Nasopharyngeal (NP) aspirate

Interventions

  • ProcedureNasopharyngeal (NP) aspirate

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

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. •Antibiotics prescriptions within the 3 previous months in children's health booklets and in a questionnaire completed by parents

    Time frame: one day

  2. • 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

  3. • Pneumococcal serotypes distribution compared to immunization status

    Time frame: one day

  4. • Comparison of the data above with the previous five cross-sectional surveys

    Time frame: one day

07

Study locations

1 site
  • Hôpital Archet 1
    Nice, 06200, France
08

References and documents

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. PubMed 24402502 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01485029
Lead sponsor
Department of Clinical Research and Innovation
Responsible party
Department of Clinical Research and Innovation (Pr PRADIER, Centre Hospitalier Universitaire de Nice) — Sponsor-investigator
First posted
Dec 5, 2011
Start date
Jan 1, 2012
Primary completion
Mar 18, 2013
Completion
Mar 18, 2014
Last update
Mar 27, 2026

Study contacts

Christian PRADIER, PU-PH
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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