Acute Otitis MediaNCT01214538
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
An observational study of Acute Otitis Media, run by NasVax Ltd at 1 site in Israel.
Trial summary
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Acute Otitis Media
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Jul 2014
- 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 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: 100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled
Who may be able to join
- Male and female Jewish and Bedouin children.
- Patients can be either ambulatory or hospitalized.
- Presenting with acute otitis media.
- Tympanocentesis was performed at least in one ear for a clinical indication.
- Culture of middle ear fluid was obtained.
- Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures.
Who cannot join
- Having another infection that is likely to be caused by S. pneumoniae.
- Known immunodeficiency.
- Known previous recent pneumococcal infections (<1 month prior to current visit).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ben-Gurion University of the Negev
Beersheba, 84101
Ron Dagan, Prof MD, +972 + 8-6400547, rdagan@bgu.ac.il
About this study
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
- Conditions
- Acute Otitis Media
- Keywords
- Vaccine pneumococcal natural history Acute otitis media
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group - culture negative | 50 children with pneumococcal culture-negative Acute Otitis Media | |
| study group- culture positive | 50 children with pneumococcal culture-positive Acute Otitis Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological studies of pneumococcal proteins and their development over time following otitis media infections
The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.
Measured: 3 months per individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NasVax Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Dagan, Prof. MD., Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214538
- Sponsor's protocol ID
- NX10-07
- Status last verified
- Sep 2011
- First submitted
- 3 Oct 2010
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
- ClinicalTrials.gov ID
- NCT01214538
- Acronym / sponsor ID
- NX10-07
- Conditions
- Acute Otitis Media
- Keywords
- Vaccine pneumococcal natural history Acute otitis media
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NasVax LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 5 Oct 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.
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - culture negative | – | –50 children with pneumococcal culture-negative Acute Otitis Media |
| study group- culture positive | – | –50 children with pneumococcal culture-positive Acute Otitis Media |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled
Key inclusion criteria (6 listed)
- Male and female Jewish and Bedouin children.
- Patients can be either ambulatory or hospitalized.
- Presenting with acute otitis media.
- Tympanocentesis was performed at least in one ear for a clinical indication.
- Culture of middle ear fluid was obtained.
Key exclusion criteria (3 listed)
- Having another infection that is likely to be caused by S. pneumoniae.
- Known immunodeficiency.
- Known previous recent pneumococcal infections (<1 month prior to current visit).
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
Serological studies of pneumococcal proteins and their development over time following otitis media infections
Time frame: 3 months per individual
The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
Related trials for Acute Otitis Media
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic 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.
Ron Dagan, Prof. MD. principal investigator
Ben-Gurion University of the Negev
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 Acute Otitis Media, run by NasVax Ltd 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 6 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: status not confirmed, as of the sponsor's last update on 27 Sep 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological studies of pneumococcal proteins and their development over time following otitis media infections (time frame: 3 months per individual). 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 27 Sep 2011.