Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children

Withdrawn

• Conditions: Infections, Streptococcal
• Interventions: Procedure: Middle ear fluid and urine.

• Registration Number: NCT01160055
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-12
• Study Start: 2012-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	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.
Cohort A	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of bacterial pathogens isolated from middle ear fluid samples.	12 Months

Secondary Outcome Measures

Name	Time	Method
Occurrence of bacterial serotypes.	12 Months
Occurrence of spontaneous otorrhoea.	12 Months
Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.	12 Months
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.	12 Months
Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.	12 Months
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.	12 Months