Streptococcus Pneumoniae Nasopharyngeal Carriage
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
December 5, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2014
CompletedMarch 27, 2026
March 1, 2026
1.2 years
September 23, 2011
March 24, 2026
Conditions
Outcome Measures
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
one day
Secondary Outcomes (4)
•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
Study Arms (1)
NP children
EXPERIMENTALNasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
Interventions
Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
Eligibility Criteria
You may qualify if:
- Children aged from 3 months to 4 years
- Attending a day care center
- Parents give informed consent
You may not qualify if:
- parents refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Archet 1
Nice, 06200, France
Related Publications (1)
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.
PMID: 24402502RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Christian PRADIER, PU-PH
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Pr PRADIER
Study Record Dates
First Submitted
September 23, 2011
First Posted
December 5, 2011
Study Start
January 1, 2012
Primary Completion
March 18, 2013
Study Completion
March 18, 2014
Last Updated
March 27, 2026
Record last verified: 2026-03