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

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.

Study Overview

• Status: Withdrawn
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Procedure: Middle ear fluid and urine.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of bacterial pathogens isolated from middle ear fluid samples.	12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of bacterial serotypes.	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 spontaneous otorrhoea.	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (Estimate): July 12, 2010

Study Record Updates

• Last Update Posted (Estimate): April 13, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Ear Diseases; Otitis; Otitis Media; Streptococcal Infections
• Other Study ID Numbers: 113368