Trial record 6 of 180 for:    "Otitis"

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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195611
First received: September 13, 2005
Last updated: June 27, 2010
Last verified: June 2010
  Purpose

The 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.


Condition Intervention Phase
Otitis Media
Otitis Media With Effusion
Pneumococcal Infections
Drug: Prevenar
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM)

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 3293
Study Start Date: September 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Screening, Cross-Sectional, Defined Population, Prospective Study

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195611

Locations
France
Auch, France, 32000
Brest, France, 29200
Canne La Boca, France, 06150
Chalons En Champagne, France, 51000
Chambery, France, 73000
Combs La Ville, France, 77380
Creteil, France, 94000
Draguignan, France, 83300
Essey Les Nancy, France, 54270
Fontenay Sous Bois, France, 94120
Grenoble, France, 38000
Grigny, France, 91350
Lagny, France, 77400
Les Lilas, France, 93260
Les Ulis, France, 91940
Lyon, France, 96003
Marquette, France, 59520
Marseille, France, 13013
Massy, France, 91300
Molsheim, France, 67120
Paris, France, 75007
Paris, France, 75116
Paris, France, 75006
Paris, France, 75020
Paris, France, 75015
Rouen, France, 76000
Saint Brieuc, France, 22000
Saint Maur Des Fosses, France, 94100
Selestat, France, 67600
Thionville, France, 57100
Toulouse, France, 31000
Tours, France, 37000
Vandoeuvre Les Nancy, France, 54500
Vence, France, 06140
Villeneuve Les Avignon, France, 30400
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195611     History of Changes
Other Study ID Numbers: 0887X-100918
Study First Received: September 13, 2005
Last Updated: June 27, 2010
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Middle Ear Infection

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Pneumococcal Infections
Pneumonia
Ear Diseases
Otorhinolaryngologic Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014