Study Stopped
Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2012
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedApril 13, 2015
April 1, 2015
8 months
July 1, 2010
April 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of bacterial pathogens isolated from middle ear fluid samples.
12 Months
Secondary Outcomes (6)
Occurrence of bacterial serotypes.
12 Months
Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.
12 Months
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
12 Months
Occurrence of spontaneous otorrhoea.
12 Months
Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.
12 Months
- +1 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
Children aged \>= 3 months to \< 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Biospecimen
Middle ear fluid, Urine.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2010
First Posted
July 12, 2010
Study Start
October 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
April 13, 2015
Record last verified: 2015-04