Trial record 14 of 230 for:    otitis

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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01031329
First received: December 10, 2009
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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
Complicated Acute Otitis Media
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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of bacterial serotypes. [ Designated as safety issue: No ]
  • Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples collected from sub-groups of complicated acute otitis media cases. [ Designated as safety issue: No ]
  • Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media. [ Designated as safety issue: No ]
  • Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. [ Designated as safety issue: No ]
  • Occurrence of spontaneous otorrhoea. [ Designated as safety issue: No ]

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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01031329

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01031329     History of Changes
Other Study ID Numbers: 111339
Study First Received: December 10, 2009
Last Updated: August 2, 2012
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014