Chronic Otitis MediaNCT01157910
Bacterial Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery
An observational study of Chronic Otitis Media and Age Determined Bacteria, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Chronic Otitis Media, Age Determined Bacteria
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Nov 2012
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children suffering from chronic otitis media who are scheduled for surgery.
Who may be able to join
- All children with chronic ear infections scheduled for surgical interventions
Who cannot join
- Children who have undergone prior mastoid surgery, or children with oncologic treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Epidemiological and Bacteriological Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery
Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections.
The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.
Read the detailed description
ibid.
- Conditions
- Chronic Otitis Media, Age Determined Bacteria
- Keywords
- Ear infection, Chronic
- Medical subject headings
- Otitis, Bronchiolitis Obliterans Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157910
- Sponsor's protocol ID
- 36-2009
- Status last verified
- Jul 2010
- First submitted
- 4 Jul 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological and Bacteriological Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery
- ClinicalTrials.gov ID
- NCT01157910
- Acronym / sponsor ID
- 36-2009
- Conditions
- Chronic Otitis Media, Age Determined Bacteria
- Keywords
- Ear infection, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 7 Jul 2010 (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.
Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections.
The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.
Detailed description
ibid.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children suffering from chronic otitis media who are scheduled for surgery.
Key inclusion criteria (1 listed)
- All children with chronic ear infections scheduled for surgical interventions
Key exclusion criteria (1 listed)
- Children who have undergone prior mastoid surgery, or children with oncologic treatments.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Otitis Media and Age Determined Bacteria, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Jul 2010. 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 Israel. 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?
Results are not available in the source record.
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 7 Jul 2010.