Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
NCT00195611
Last updated date
ABOUT THIS STUDY
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.
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
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
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.
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Otitis Media, Otitis Media With Effusion, Pneumococcal InfectionsStudy of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
NCT00195611
- Auch,
- Brest,
- Canne La Boca,
- Chalons En Champagne,
- Chambery,
- Combs La Ville,
- Creteil,
- Draguignan,
- Essey Les Nancy,
- Fontenay Sous Bois,
- Grenoble,
- Grigny,
- Lagny,
- Les Lilas,
- Les Ulis,
- Lyon,
- Marquette,
- Marseille,
- Massy,
- Molsheim,
- Paris,
- Paris,
- Paris,
- Paris,
- Paris,
- Rouen,
- Saint Brieuc,
- Saint Maur Des Fosses,
- Selestat,
- Thionville,
- Toulouse,
- Tours,
- Vandoeuvre Les Nancy,
- Vence,
- Villeneuve Les Avignon,
ALL GENDERS
6 Months+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media | |||
| Official Title | Observational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM) | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | Screening, Cross-Sectional, Defined Population, Prospective Study | |||
| Condition |
| |||
| Intervention | Drug: Prevenar | |||
| Study Groups/Cohorts | Not 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 Status | Completed | |||
| Actual Enrollment | 3293 | |||
| Original Enrollment | 3600 | |||
| Actual Study Completion Date | June 2006 | |||
| Actual Primary Completion Date | June 2006 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Other inclusion applies. Exclusion Criteria: | |||
| Sex/Gender |
| |||
| Ages | 6 Months to 24 Months (Child) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00195611 | |||
| Other Study ID Numbers | 0887X-100918 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | June 2010 | |||