Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia

GlaxoSmithKline1 site in 1 country66 target enrollmentJune 2009

ConditionsInfections, Streptococcal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infections, Streptococcal
Sponsor: GlaxoSmithKline
Enrollment: 66
Locations: 1
Primary Endpoint: Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to identify the bacterial aetiology of acute otitis media episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 2011

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A child will be eligible for inclusion if he/she meets the following criteria:
•Age: ≥ 3 months and \< 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
•Signs, symptoms, and conditions: i. One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever AND EITHER ii. Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) OR iii. Spontaneous otorrhoea of less than 24 hours
•Onset of signs and symptoms of AOM within 72 hours prior to diagnosis of AOM by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment
•Written informed consent obtained from parent or guardian prior to study start.

Exclusion Criteria

•The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.
•Hospitalised during the diagnosis of AOM or during treatment,
•Otitis externa, or otitis media with effusion
•Presence of a transtympanic aerator
•Systemic antibiotic treatment received for a disease other than AOM in the 72 hours prior to enrolment,
•Receiving antimicrobial prophylaxis for recurrent AOM,
•Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit, prior to the sampling
•Patients on antibiotics for AOM who are clinically improving.

Outcomes

Primary Outcomes

Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples

Time Frame: Average time frame: 12 months

Secondary Outcomes

Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy(Average time frame: 12 months)
Occurrence of spontaneous otorrhea(Average time frame: 12 months)
Occurence of H. influenzae and S. pneumoniae serotypes(Average time frame: 12 months)
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques(Average time frame: 12 months)
Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine(Average time frame: 12 months)
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media (≥ 3 episodes in the last 6 months or ≥ 4 episodes in 12 months)(Average time frame: 12 months)