Streptococcus Pneumoniae Nasopharyngeal Carriage

Nursery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01485029
• Other study ID #: 11-APN-01
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2011
• Last updated: December 17, 2012
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christian PRADIER, PU-PH
• Email: pradier.c[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 4 Years

Eligibility

Inclusion Criteria:

• Children aged from 3 months to 4 years

• Attending a day care center

• Parents give informed consent

Exclusion Criteria:

• parents refusal

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nursery

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Archet 1	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Department of Clinical Research and Innovation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	•Antibiotics prescriptions within the 3 previous months in children's health booklets and in a questionnaire completed by parents		one day	No
Secondary	• Immunization status for pneumococcal conjugate vaccine PCV7-type vaccine from children's health books and from day care centres health files		one day	No
Secondary	• Pneumococcal serotypes distribution compared to immunization status		one day	No
Secondary	• Comparison of the data above with the previous five cross-sectional surveys		one day	No