Infections, StreptococcalNCT01160055
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
An observational study of Infections, Streptococcal, run by GlaxoSmithKline.
Trial summary
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Middle ear fluid and urine.
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jun 2013
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged >= 3 months to < 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.
Who may be able to join
- Age: >= 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
- Signs, symptoms, and conditions:
- One of the functional or general signs of otalgia, conjunctivitis, fever AND EITHER
- Paradise's criteria, OR
- Spontaneous otorrhoea of less than 1 day.
- Onset of signs and symptoms of acute otitis media within 3 days prior to diagnosis of acute otitis media by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 2-3 days after initiation of treatment.
- Written informed consent obtained from parent(s) or Legally Acceptable Representative prior to study start.
Who cannot join
- Hospitalised during the diagnosis of acute otitis media or during treatment,
- Otitis externa, or otitis media with effusion,
- Presence of a transtympanic aerator,
- Systemic antibiotic treatment received for a disease other than acute otitis media in the 3 days prior to enrolment,
- Receiving antimicrobial prophylaxis for recurrent acute otitis media,
- Provision of antibiotic by the ear nose and throat specialist at the enrolment visit, prior to the sampling of the middle ear fluid by tympanocentesis or spontaneous otorrhoea,
- Patients on antibiotics for acute otitis media who are clinically improving.
- Child in care.
About this study
Official title: Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.
- Conditions
- Infections, Streptococcal
- Being tested
- Middle ear fluid and urine.
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle ear fluid and urine.Procedure or surgery
Middle ear fluid and urine collection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Subjects with a new episode of Acute Otitis Media (<3 days of onset) who have not yet received antibiotic therapy for the episode. Receives: Procedure: Middle ear fluid and urine. | |
| Cohort B | Subjects who have had a diagnosis of Acute Otitis Media within 2-3 days prior to study enrolment and received antibiotic therapy, but remain symptomatic. Receives: Procedure: Middle ear fluid and urine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of bacterial pathogens isolated from middle ear fluid samples.
Measured: 12 Months
Secondary outcomes (6)
Occurrence of bacterial serotypes.
Measured: 12 Months
Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.
Measured: 12 Months
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
Measured: 12 Months
Occurrence of spontaneous otorrhoea.
Measured: 12 Months
Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.
Measured: 12 Months
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startOct 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160055
- Sponsor's protocol ID
- 113368
- Status last verified
- Apr 2015
- First submitted
- 1 Jul 2010
- Last updated
- 13 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt
- ClinicalTrials.gov ID
- NCT01160055
- Acronym / sponsor ID
- 113368
- Conditions
- Infections, Streptococcal
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 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.
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: Middle ear fluid and urine.Subjects with a new episode of Acute Otitis Media (<3 days of onset) who have not yet received antibiotic therapy for the episode. |
| Cohort B | – | Procedure: Middle ear fluid and urine.Subjects who have had a diagnosis of Acute Otitis Media within 2-3 days prior to study enrolment and received antibiotic therapy, but remain symptomatic. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged >= 3 months to < 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.
Key inclusion criteria (7 listed)
- Age: >= 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
- Signs, symptoms, and conditions:
- One of the functional or general signs of otalgia, conjunctivitis, fever AND EITHER
- Paradise's criteria, OR
- Spontaneous otorrhoea of less than 1 day.
Key exclusion criteria (8 listed)
- Hospitalised during the diagnosis of acute otitis media or during treatment,
- Otitis externa, or otitis media with effusion,
- Presence of a transtympanic aerator,
- Systemic antibiotic treatment received for a disease other than acute otitis media in the 3 days prior to enrolment,
- Receiving antimicrobial prophylaxis for recurrent acute otitis media,
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 |
|---|---|---|
| Middle ear fluid and urine.Middle ear fluid and urine collection. | Procedure or surgery | Cohort A, Cohort B |
Primary outcome
Occurrence of bacterial pathogens isolated from middle ear fluid samples.
Time frame: 12 Months
6 secondary outcomes
Occurrence of bacterial serotypes.
Time frame: 12 Months
Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.
Time frame: 12 Months
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
Time frame: 12 Months
Occurrence of spontaneous otorrhoea.
Time frame: 12 Months
Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.
Time frame: 12 Months
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Streptococcal, run by GlaxoSmithKline.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of bacterial pathogens isolated from middle ear fluid samples. (time frame: 12 Months). 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 13 Apr 2015.