Clinical trial NCT01160055: Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
Official title: Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infections, Streptococcal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Primary outcomes:
measure: Occurrence of bacterial pathogens isolated from middle ear fluid samples.
timeFrame: 12 Months
Secondary outcomes:
measure: Occurrence of bacterial serotypes.
timeFrame: 12 Months
measure: Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.
timeFrame: 12 Months
measure: Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
timeFrame: 12 Months
measure: Occurrence of spontaneous otorrhoea.
timeFrame: 12 Months
measure: Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.
timeFrame: 12 Months
measure: Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: