Clinical trial NCT01204385: Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Streptococcal
Keywords: Non-typeable Haemophilus Influenzae
Acute Otitis Media
Streptococcus Pneumoniae
etiology
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged ≥ 3 months and \< 5 years of age, diagnosed as having AOM

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 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.

Primary outcomes:
measure: Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples
timeFrame: Average time frame: 12 months
Secondary outcomes:
measure: Occurence of H. influenzae and S. pneumoniae serotypes
timeFrame: Average time frame: 12 months
measure: Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques
timeFrame: Average time frame: 12 months
measure: 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)
timeFrame: Average time frame: 12 months
measure: Occurrence of spontaneous otorrhea
timeFrame: Average time frame: 12 months
measure: Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy
timeFrame: Average time frame: 12 months
measure: Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine
timeFrame: Average time frame: 12 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: