Last updated: 11/03/2018 11:33:47
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
GSK study ID
111337
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia
Trial description: The purpose of the study is to identify the bacterial aetiology of acute otitis media episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples
Timeframe: Average time frame: 12 months
Secondary outcomes:
Occurence of H. influenzae and S. pneumoniae serotypes
Timeframe: Average time frame: 12 months
Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques
Timeframe: Average time frame: 12 months
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media (≥ 3 episodes in the last 6 months or ≥ 4 episodes in 12 months)
Timeframe: Average time frame: 12 months
Occurrence of spontaneous otorrhea
Timeframe: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy
Timeframe: Average time frame: 12 months
Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine
Timeframe: Average time frame: 12 months
Interventions:
Procedure/surgery: Sample collection
Enrollment:
66
Observational study model:
Case-Only
Primary completion date:
2011-16-05
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Streptococcal
Product
GSK2647154A
Collaborators
Not applicable
Study date(s)
June 2009 to May 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
3 months - 5 years
Accepts healthy volunteers
No
- A child will be eligible for inclusion if he/she meets the following criteria:
- Age: ≥ 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
- The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.
- Hospitalised during the diagnosis of AOM or during treatment,
Inclusion and exclusion criteria
Inclusion criteria:
- A child will be eligible for inclusion if he/she meets the following criteria:
- Age: ≥ 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
- Signs, symptoms, and conditions: i. One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever AND EITHER ii. Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) OR iii. Spontaneous otorrhoea of less than 24 hours
- Onset of signs and symptoms of AOM within 72 hours prior to diagnosis of AOM by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment
- Written informed consent obtained from parent or guardian prior to study start.
Exclusion criteria:
- The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.
- Hospitalised during the diagnosis of AOM or during treatment,
- Otitis externa, or otitis media with effusion
- Presence of a transtympanic aerator
- Systemic antibiotic treatment received for a disease other than AOM in the 72 hours prior to enrolment,
- Receiving antimicrobial prophylaxis for recurrent AOM,
- Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit, prior to the sampling
- Patients on antibiotics for AOM who are clinically improving.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2011-16-05
Actual study completion date
2011-16-05
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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