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Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children

This study has been withdrawn prior to enrollment.
(Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.)
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 1, 2010
Last updated: April 9, 2015
Last verified: April 2015
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.

Condition Intervention
Infections, Streptococcal
Procedure: Middle ear fluid and urine.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of bacterial pathogens isolated from middle ear fluid samples. [ Time Frame: 12 Months ]

Secondary Outcome Measures:
  • Occurrence of bacterial serotypes. [ Time Frame: 12 Months ]
  • Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques. [ Time Frame: 12 Months ]
  • Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media. [ Time Frame: 12 Months ]
  • Occurrence of spontaneous otorrhoea. [ Time Frame: 12 Months ]
  • Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy. [ Time Frame: 12 Months ]
  • Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. [ Time Frame: 12 Months ]

Biospecimen Retention:   Samples Without DNA
Middle ear fluid, Urine.

Enrollment: 0
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort A
Subjects with a new episode of Acute Otitis Media (<3 days of onset) who have not yet received antibiotic therapy for the episode.
Procedure: Middle ear fluid and urine.
Middle ear fluid and urine collection.
Cohort B
Subjects who have had a diagnosis of Acute Otitis Media within 2-3 days prior to study enrolment and received antibiotic therapy, but remain symptomatic.
Procedure: Middle ear fluid and urine.
Middle ear fluid and urine collection.


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
Children aged >= 3 months to < 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.

Inclusion Criteria:

  • Age: >= 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
  • Signs, symptoms, and conditions:
  • One of the functional or general signs of otalgia, conjunctivitis, fever AND EITHER
  • Paradise's criteria, OR
  • Spontaneous otorrhoea of less than 1 day.
  • Onset of signs and symptoms of acute otitis media within 3 days prior to diagnosis of acute otitis media by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 2-3 days after initiation of treatment.
  • Written informed consent obtained from parent(s) or Legally Acceptable Representative prior to study start.

Exclusion Criteria:

  • Hospitalised during the diagnosis of acute otitis media or during treatment,
  • Otitis externa, or otitis media with effusion,
  • Presence of a transtympanic aerator,
  • Systemic antibiotic treatment received for a disease other than acute otitis media in the 3 days prior to enrolment,
  • Receiving antimicrobial prophylaxis for recurrent acute otitis media,
  • Provision of antibiotic by the ear nose and throat specialist at the enrolment visit, prior to the sampling of the middle ear fluid by tympanocentesis or spontaneous otorrhoea,
  • Patients on antibiotics for acute otitis media who are clinically improving.
  • Child in care.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01160055

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01160055     History of Changes
Other Study ID Numbers: 113368
Study First Received: July 1, 2010
Last Updated: April 9, 2015

Additional relevant MeSH terms:
Otitis Media
Streptococcal Infections
Ear Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on May 25, 2017