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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Cancelled
Cancelled
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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:
- 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.
Age: >= 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
Exclusion criteria:
- 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.
Hospitalised during the diagnosis of acute otitis media or during treatment,
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Cancelled
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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