Otitis MediaNCT00768534
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
An observational study of Otitis Media, run by Pfizer at 1 site in Germany.
Trial summary
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Otitis Media
- How many people
- 2,138 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Oct 2015
- 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 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: community sample
Who may be able to join
- Main inclusion criteria:
- Children >= 2 months and =< 5 years
- Spontaneous draining AOM =< 2 days Main
Who cannot join
- Previous operation of the ear
- Chronic otitis media or tube placement with drainage >= 3 days
- Chronic disease/immune deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
- Conditions
- Otitis Media
- Keywords
- Acute Otitis Media, Serotype distribution
- Medical subject headings
- Otitis Media
What is being measured
The primary outcome is the main question the study is designed to answer.
serotype distribution
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2015
- Study completionOct 2015
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768534
- Sponsor's protocol ID
- 0887X1-4454
- Other IDs
- B1841014
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2008
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates
- ClinicalTrials.gov ID
- NCT00768534
- Acronym / sponsor ID
- 0887X1-4454
- Conditions
- Otitis Media
- Keywords
- Acute Otitis Media, Serotype distribution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,138 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Oct 2008 (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.
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- community sample
Key inclusion criteria (3 listed)
- Children >= 2 months and =< 5 years
- Spontaneous draining AOM =< 2 days Main
Key exclusion criteria (3 listed)
- Previous operation of the ear
- Chronic otitis media or tube placement with drainage >= 3 days
- Chronic disease/immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serotype distribution
Time frame: 30 days
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 6 Oct 2016.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Otitis Media
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Active, not recruiting
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Acute Otitis Media
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
Acute Otitis Media (AOM)
Active, not recruitingObservational study
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Nasopharyngeal Colonization and Acute Otitis Media
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site 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, run by Pfizer at 1 site in Germany.
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 3 inclusion and 3 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 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does the primary outcome measure?
serotype distribution (time frame: 30 days). It is what the study was designed to measure, not a finding.
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 6 Oct 2016.