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

NCT01031329 | Withdrawn

• 1 other identifier: 111339
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Infections, Streptococcal

Outcome Measures

Primary Outcomes (1)

• Occurrence of bacterial pathogens isolated from middle ear fluid samples.

Secondary Outcomes (5)

• 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.

Study Arms (1)

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

Interventions

Tympanocenthesis and urine collection PROCEDURE

Fluid using needle aspiration is obtained from middle ear fluid. Urine is collected using a urine bag.

Complicated Acute otitis media Group

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Adana, 1330, Turkey (Türkiye)

Location

GSK Investigational Site

Adana, Turkey (Türkiye)

Location

GSK Investigational Site

Ankara, 6100, Turkey (Türkiye)

Location

GSK Investigational Site

Ankara, Turkey (Türkiye)

Location

GSK Investigational Site

Istanbul, 34280, Turkey (Türkiye)

Location

GSK Investigational Site

Istanbul, Turkey (Türkiye)

Location

GSK Investigational Site

Izmir, 35100, Turkey (Türkiye)

Location

GSK Investigational Site

Izmir, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Middle ear fluid and urine.

MeSH Terms

Conditions

Streptococcal Infections

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

TU (8)