Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
This study has been withdrawn prior to enrollment.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160055
First received: July 1, 2010
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Otitis Media |
Procedure: Middle ear fluid and urine. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of bacterial pathogens isolated from middle ear fluid samples. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of bacterial serotypes. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Occurrence of spontaneous otorrhoea. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Middle ear fluid, Urine.
| Enrollment: | 0 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Procedure: Middle ear fluid and urine.
Middle ear fluid and urine collection.
|
|
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.
|
Procedure: Middle ear fluid and urine.
Middle ear fluid and urine collection.
|
Eligibility| Ages Eligible for Study: | 3 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Children aged >= 3 months to < 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01160055 History of Changes |
| Other Study ID Numbers: | 113368 |
| Study First Received: | July 1, 2010 |
| Last Updated: | August 2, 2012 |
| Health Authority: | Egypt: Ministry of Health |
Additional relevant MeSH terms:
|
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013