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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160055
First received: July 1, 2010
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Acute Otitis Media
Procedure: Middle ear fluid and urine.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt

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. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of bacterial serotypes. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Occurrence of spontaneous otorrhoea. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle ear fluid, Urine.


Enrollment: 0
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Middle ear fluid and urine.
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.
Procedure: Middle ear fluid and urine.
Middle ear fluid and urine collection.

  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

Children aged >= 3 months to < 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160055

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01160055     History of Changes
Other Study ID Numbers: 113368
Study First Received: July 1, 2010
Last Updated: August 2, 2012
Health Authority: Egypt: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013