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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 16, 2010
Last updated: January 9, 2014
Last verified: January 2014

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.

Condition Intervention
Infections, Streptococcal
Procedure: Sample collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurence of H. influenzae and S. pneumoniae serotypes [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence of spontaneous otorrhea [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle ear fluid and urine

Enrollment: 66
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Group
Not Applicable
Procedure: Sample collection
Middle ear fluid and urine


Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
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:

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01204385

Saudi Arabia
GSK Investigational Site
Riyadh, Saudi Arabia
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT01204385     History of Changes
Other Study ID Numbers: 111337
Study First Received: September 16, 2010
Last Updated: January 9, 2014
Health Authority: Kingdom of Saudi Arabia: Saudi Food & Drug Authority "SFDA"

Keywords provided by GlaxoSmithKline:
Non-typeable Haemophilus Influenzae
Acute Otitis Media
Streptococcus Pneumoniae

Additional relevant MeSH terms:
Otitis Media
Streptococcal Infections
Ear Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on April 16, 2014