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Nasopharyngeal Carriage of S. Pneumoniae

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ClinicalTrials.gov Identifier: NCT04460313
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Association Clinique Thérapeutique Infantile du val de Marne

Brief Summary:
This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carriage Children, Only Antibiotic Resistant Strain Other: nasopharyngeal sample Not Applicable

Detailed Description:
Since September 2001, 121 pediatricians who are part of a research and teaching network (ACTIV) throughout France participated at this prospective study. From October to June of each subsequent year, children of both sexes suffering from suppurative acute otitis media (AOM) with fever and/or otalgia (in order to increase the probability of pneumococcal AOM), aged 6 to 24 months, were enrolled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: multicenter nationwide prospective cohort
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Observatoire du Portage rhinopharyngé de Streptococcus Pneumoniae (Sp) Chez Des Nourrissons Ayant Une Otite Moyenne aiguë (OMA) et Sains - Etude Ancillaire Sur la détection Des Porteurs de E Coli BLSE
Actual Study Start Date : September 11, 2001
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
prospective cohort
Nasopharyngeal sample for each enrrolled children
Other: nasopharyngeal sample
nasopharyngeal swabs from children with acute otitis media aged 6 to 24 months. The swabs were analyzed by the French National Reference Centre for Pneumococci.




Primary Outcome Measures :
  1. S. Pneumoniae colonisation to detect emerging serotypes [ Time Frame: at inclusion ]
    The percentage of children colonised by non vaccine serotypes -


Secondary Outcome Measures :
  1. Detect the emergence of resistance S. pneumoniae [ Time Frame: at inclusion ]
    Percentage of penicillin resistant S. pneumoniae

  2. Evaluation of the rhinopharyngeal carriage of other bacteria [ Time Frame: at inclusion ]
    Haemophilus influenzae, Moraxella Catarrhalis, and Staphylococcus aureus in AOM group and healthy children.

  3. Detect the emergence of new serotypes [ Time Frame: at inclusion ]
    > 10 Percent of isolated Sp, 5 percent of carrier children



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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • both sexes
  • suffering from suppurative AOM
  • age: 6 months to 24 months for AOM
  • age: 6 months to 15 years for healthy children
  • informed consent from parents or guardians

Exclusion Criteria:

  • Children with antibiotic treatment within 7 days before enrolment,
  • severe underlying disease,
  • inclusion in the study during the previous 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460313


Contacts
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Contact: Corinne Levy, MD 0033148850404 corinne.levy@activ-france.fr
Contact: Stéphane Béchet, MsC 0033148850404 stephane.bechet@activ-france.fr

Locations
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France
ACTIV Recruiting
Créteil, France
Contact: Corinne Levy, MD    0033148850404    corinne.levy@activ-france.fr   
Contact: Stéphane Béchet, MSc    0033148850404    stephane.bechet@activ-france.fr   
Sponsors and Collaborators
Association Clinique Thérapeutique Infantile du val de Marne
Pfizer
Investigators
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Principal Investigator: Robert Cohen, MD Association Clinique Thérapeutique Infantile du val de Marne
Additional Information:
Publications of Results:

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Responsible Party: Association Clinique Thérapeutique Infantile du val de Marne
ClinicalTrials.gov Identifier: NCT04460313    
Other Study ID Numbers: ACT0806
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Clinique Thérapeutique Infantile du val de Marne:
Pneumococcal conjugate vaccine
Streptococcus pneumoniae
Carriage
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases