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

Infections, Streptococcal Clinical Trial

Official title:

Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Turkey

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01031329
• Other study ID #: 111339
• Status: Withdrawn
• Phase: N/A
• First received: December 10, 2009
• Last updated: April 9, 2015
• Start date: November 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Streptococcal
• Otitis Media
• Streptococcal Infections

Intervention

Procedure:
• Tympanocenthesis and urine collection
Fluid using needle aspiration is obtained from middle ear fluid. Urine is collected using a urine bag.

Locations

Country	Name	City	State
Turkey	GSK Investigational Site	Adana
Turkey	GSK Investigational Site	Adana
Turkey	GSK Investigational Site	Ankara
Turkey	GSK Investigational Site	Ankara
Turkey	GSK Investigational Site	Istanbul
Turkey	GSK Investigational Site	Istanbul
Turkey	GSK Investigational Site	Izmir
Turkey	GSK Investigational Site	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of bacterial pathogens isolated from middle ear fluid samples.			No
Secondary	Occurrence of bacterial serotypes.			No
Secondary	Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples collected from sub-groups of complicated acute otitis media cases.			No
Secondary	Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.			No
Secondary	Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.			No
Secondary	Occurrence of spontaneous otorrhoea.			No