CompletedNCT01204385Updated Jan 13, 2014

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

An observational study in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 1 site in Saudi Arabia. Open to participants aged 3 Months to 5 Years. Per ClinicalTrials.gov, last updated 2014-01-13.

Sponsored by GlaxoSmithKline · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 66
Ages: 3 Months to 5 Years
Sex: All

Study 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.

Conditions studied

Infections, Streptococcal

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Keywords

Non-typeable Haemophilus Influenzae
Acute Otitis Media
Streptococcus Pneumoniae
etiology

In context

Streptococcal Infections

155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.

This study's enrollment of 66 is below the median of 339 across 42 observational studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Months to 5 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Subjects aged ≥ 3 months and \< 5 years of age, diagnosed as having AOM

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

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.

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 66 participants (actual)
Biospecimen retention: Samples without dna

Groups and cohorts

Study Group
Procedure: Sample collection

Interventions

ProcedureSample collection
Middle ear fluid and urine

What researchers measure

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

Occurence of H. influenzae and S. pneumoniae serotypes
Time frame: 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
Time frame: 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)
Time frame: Average time frame: 12 months
Occurrence of spontaneous otorrhea
Time frame: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy
Time frame: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine
Time frame: Average time frame: 12 months

Study locations

1 site

GSK Investigational Site
Riyadh, Saudi Arabia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01204385
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Sep 17, 2010
Start date: Jun 2009
Primary completion: May 2011
Completion: May 2011
Last update: Jan 13, 2014

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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