Status:
WITHDRAWN
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
3-5 years
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01160055
Start Date
October 1 2012
End Date
June 1 2013
Last Update
April 13 2015
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