Last updated: 11/03/2018 14:53:39

Study to characterize and identify bacteria causing Acute Otitis Media in young Egyptian children

GSK study ID
113368
Clinicaltrials.gov ID
NCT01160055
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Identification and characterisation of the bacteria causing Acute Otitis Media (AOM) episodes in young children in Egypt
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of bacterial pathogens isolated from middle ear fluid samples.

Timeframe: 12 Months

Secondary outcomes:

Occurrence of bacterial serotypes.

Timeframe: 12 Months

Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.

Timeframe: 12 Months

Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.

Timeframe: 12 Months

Occurrence of spontaneous otorrhoea.

Timeframe: 12 Months

Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.

Timeframe: 12 Months

Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.

Timeframe: 12 Months

Interventions:
  • Procedure/surgery: Middle ear fluid and urine.
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Streptococcal
    Product
    GSK2647154A
    Collaborators
    Not applicable
    Study date(s)
    October 2012 to June 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    3 months - 5 years
    Accepts healthy volunteers
    No
    • Age: >= 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
    • Signs, symptoms, and conditions:
    • Hospitalised during the diagnosis of acute otitis media or during treatment,
    • Otitis externa, or otitis media with effusion,
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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