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

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ClinicalTrials.gov Identifier: NCT01204385
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : January 13, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Infections, Streptococcal Procedure: Sample collection

Study Type : Observational
Actual Enrollment : 66 participants
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
Study Start Date : June 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Group/Cohort Intervention/treatment
Study Group Procedure: Sample collection
Middle ear fluid and urine

Primary Outcome Measures :
  1. Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples [ Time Frame: Average time frame: 12 months ]

Secondary Outcome Measures :
  1. Occurence of H. influenzae and S. pneumoniae serotypes [ Time Frame: Average time frame: 12 months ]
  2. 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 ]
  3. 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 ]
  4. Occurrence of spontaneous otorrhea [ Time Frame: Average time frame: 12 months ]
  5. 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 ]
  6. Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine [ Time Frame: Average time frame: 12 months ]

Biospecimen Retention:   Samples Without DNA
Middle ear fluid and urine

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204385

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01204385     History of Changes
Other Study ID Numbers: 111337
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

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