Otitis MediaNCT00195611
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
An observational study of Otitis Media and Otitis Media With Effusion, run by Wyeth is now a wholly owned subsidiary of Pfizer at 35 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Otitis Media, Otitis Media With Effusion, Pneumococcal Infections
- What is being tested?
- Prevenar
- How many people
- 3,293 participants
- Where
- 35 sitesFrance
- Study dates
- Sep 2005to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Screening, Cross-Sectional, Defined Population, Prospective Study
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
France35 sites
Study site
Auch, 32000
Study site
Brest, 29200
Study site
Canne La Boca, 06150
Study site
Châlons-en-Champagne, 51000
Study site
Chambéry, 73000
Study site
Combs-la-Ville, 77380
Study site
Créteil, 94000
Study site
Draguignan, 83300
Study site
Essey-lès-Nancy, 54270
Study site
Fontenay-sous-Bois, 94120
Study site
Grenoble, 38000
Study site
Grigny, 91350
Study site
Lagny, 77400
Study site
Les Lilas, 93260
Study site
Les Ulis, 91940
Study site
Lyon, 96003
Study site
Marquette-lez-Lille, 59520
Study site
Marseille, 13013
Study site
Massy, 91300
Study site
Molsheim, 67120
Study site
Paris, 75006
Study site
Paris, 75007
Study site
Paris, 75015
Study site
Paris, 75020
Study site
Paris, 75116
Study site
Rouen, 76000
Study site
Saint-Brieuc, 22000
Study site
Saint-Maur-des-Fossés, 94100
Study site
Sélestat, 67600
Study site
Thionville, 57100
Study site
Toulouse, 31000
Study site
Tours, 37000
Study site
Vandœuvre-lès-Nancy, 54500
Study site
Vence, 06140
Study site
Villeneuve-lès-Avignon, 30400
About this study
Official title: Observational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM)
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.
- Being tested
- Prevenar
- Keywords
- Middle Ear Infection
- Medical subject headings
- Otitis Media, Otitis Media with Effusion, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevenarDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195611
- Sponsor's protocol ID
- 0887X-100918
- Status last verified
- Jun 2010
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM)
- ClinicalTrials.gov ID
- NCT00195611
- Acronym / sponsor ID
- 0887X-100918
- Keywords
- Middle Ear Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,293 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Screening, Cross-Sectional, Defined Population, Prospective Study
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevenar | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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Nasopharyngeal Carriage of S. Pneumoniae
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media and Otitis Media With Effusion, run by Wyeth is now a wholly owned subsidiary of Pfizer at 35 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.