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

NCT ID: NCT01160055

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

Conditions

Infections, Streptococcal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Middle ear fluid and urine.

Intervention Type: PROCEDURE

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.

Middle ear fluid and urine.

Intervention Type: PROCEDURE

Middle ear fluid and urine collection.

Interventions

Middle ear fluid and urine.

Middle ear fluid and urine collection.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

113368

Identifier Type: -

Identifier Source: org_study_id