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Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Auch, , 32000 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Otitis Media, Otitis Media With Effusion, Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-24 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Infants aged from 6 to 24 months

- Presenting with AOM (ear infection)

- Patients must not have received any antibiotic therapy within the past 7 days.

Other inclusion applies.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00195611
Pfizer
Completed
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media

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Descriptive Information
Brief TitleStudy of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
Official TitleObservational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM)
Brief SummaryThe aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationScreening, Cross-Sectional, Defined Population, Prospective Study
Condition
  • Otitis Media
  • Otitis Media With Effusion
  • Pneumococcal Infections
InterventionDrug: Prevenar
Study Groups/CohortsNot Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: September 1, 2009)
3293
Original Enrollment
 (submitted: September 15, 2005)
3600
Actual Study Completion DateJune 2006
Actual Primary Completion DateJune 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Infants aged from 6 to 24 months
  • Presenting with AOM (ear infection)
  • Patients must not have received any antibiotic therapy within the past 7 days.

Other inclusion applies.

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study:All
Ages6 Months to 24 Months   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195611
Other Study ID Numbers0887X-100918
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJune 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now