Streptococcus Pneumoniae Nasopharyngeal Carriage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01485029
First received: September 23, 2011
Last updated: December 17, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention
Nursery
Procedure: Nasopharyngeal (NP) aspirate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • •Antibiotics prescriptions within the 3 previous months in children's health booklets and in a questionnaire completed by parents [ Time Frame: one day ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • Pneumococcal serotypes distribution compared to immunization status [ Time Frame: one day ] [ Designated as safety issue: No ]
  • • Comparison of the data above with the previous five cross-sectional surveys [ Time Frame: one day ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • parents refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485029

Contacts
Contact: Christian PRADIER, PU-PH pradier.c@chu-nice.fr
Contact: Vanina OLIVERI, ARC 0033 4 92 03 42 54 oliveri.v@chu-nice.fr

Locations
France
Hôpital Archet 1 Recruiting
Nice, France, 06200
Contact: Pascale BRUNO, PH       bruno.p@chu-nice.fr   
Contact: Vanina OLIVERI, ARC    0033 4 92 03 42 54    oliveri.v@chu-nice.fr   
Principal Investigator: Christian PRADIER, PU-PH         
Sub-Investigator: Pascale BRUNO, PH         
Sub-Investigator: Brigitte DUNAIS, PH         
Sub-Investigator: Pia TOUBOUL, PH         
Sponsors and Collaborators
Department of Clinical Research and Innovation
Investigators
Principal Investigator: Christian PRADIER, PU-PH CHU de Nice
  More Information

No publications provided

Responsible Party: Department of Clinical Research and Innovation, Pr PRADIER, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01485029     History of Changes
Other Study ID Numbers: 11-APN-01
Study First Received: September 23, 2011
Last Updated: December 17, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 24, 2014