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

This study has been withdrawn prior to enrollment.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: December 10, 2009
Last updated: April 9, 2015
Last verified: April 2015
The purpose of this study is to identify and characterize the bacteria causing complicated Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey.

Condition Intervention
Infections, Streptococcal Procedure: Tympanocenthesis and urine 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 Turkey

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.

Secondary Outcome Measures:
  • Occurrence of bacterial serotypes.
  • Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples collected from sub-groups of complicated acute otitis media cases.
  • Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
  • Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
  • Occurrence of spontaneous otorrhoea.

Biospecimen Retention:   Samples Without DNA
Middle ear fluid and urine.

Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Complicated Acute otitis media Group

This group was divided into 3 sub-groups.

  • One sub-group includes treatment failure subjects who have had a diagnosis of acute otitis media and showed no clinical improvement within 48-72 hours of antibiotic treatment or reappearance of symptoms within 10 days following the end of antibiotic treatment.
  • The second sub-group includes subjects with recurrent acute otitis media, who have had new episodes of acute otitis media within the past 6 months or the fourth (or greater) new episode within the past year.
  • The third sub-group includes subjects with spontaneous otorrhoea if perforation has occurred < 24 hours prior to the visit.
Procedure: Tympanocenthesis and urine collection
Fluid using needle aspiration is obtained from middle ear fluid. Urine is collected using a urine bag.


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, diagnosed as having complicated acute otitis media on routine clinical care in the study hospitals.

Inclusion Criteria:

  • Age: >= 3 months and < 5 years at the time they are seen by the paediatrician. 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 24 hours.
  • Subjects if classified as recurrent acute otitis media or treatment failure as described below:
  • Recurrent acute otitis media: Defined as a subject who has an episode of acute otitis media representing the third new episode within the past 6 months, or the fourth new episode within the past year.
  • Treatment failure: Defined as a subject who was diagnosed with acute otitis media and received antibiotic treatment from a physician, but is still symptomatic 48-72 hours after initiation of the treatment. As with other acute otitis media cases, the onset of signs or symptoms should have been within 72 hours prior to the initial visit to the physician.
  • Written informed consent obtained from parent or guardian 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 72 hours prior to enrolment.
  • Receiving antimicrobial prophylaxis for recurrent acute otitis media.
  • Provision of antibiotic by paediatrician at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous otorrhoea.
  • Patients that are on antibiotics for acute otitis media, and are clinically improving.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01031329

GSK Investigational Site
Adana, Turkey, 1330
GSK Investigational Site
Adana, Turkey
GSK Investigational Site
Ankara, Turkey, 6100
GSK Investigational Site
Ankara, Turkey
GSK Investigational Site
Istanbul, Turkey, 34280
GSK Investigational Site
Istanbul, Turkey
GSK Investigational Site
Izmir, Turkey, 35100
GSK Investigational Site
Izmir, Turkey
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01031329     History of Changes
Other Study ID Numbers: 111339
Study First Received: December 10, 2009
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 September 21, 2017