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This study has been withdrawn prior to enrollment.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
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: 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 August 28, 2014