Status:
COMPLETED
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
3-5 years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01204385
Start Date
June 1 2009
End Date
May 1 2011
Last Update
January 13 2014
Active Locations (1)
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1
GSK Investigational Site
Riyadh, Saudi Arabia