Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Streptococcal

Treatments: Procedure: Sample collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01204385

111337

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

66 participants in 1 patient group

Study Group

Treatment:

Procedure: Sample collection