Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2012-01-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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NP children
Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
Nasopharyngeal (NP) aspirate
Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
Interventions
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Nasopharyngeal (NP) aspirate
Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
Eligibility Criteria
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Inclusion Criteria
* Attending a day care center
* Parents give informed consent
Exclusion Criteria
3 Months
4 Years
ALL
Yes
Sponsors
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Department of Clinical Research and Innovation
OTHER
Responsible Party
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Department of Clinical Research and Innovation
Pr PRADIER
Principal Investigators
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Christian PRADIER, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Locations
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Hôpital Archet 1
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Pascale BRUNO, PH
Role: primary
Vanina OLIVERI, ARC
Role: backup
Other Identifiers
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11-APN-01
Identifier Type: -
Identifier Source: org_study_id