Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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:
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 June 18, 2013