Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Middle ear fluid and urine. | Procedure | Middle ear fluid and urine collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of bacterial pathogens isolated from middle ear fluid samples. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of bacterial serotypes. | 12 Months | |
| Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques. | 12 Months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Children aged >= 3 months to < 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
Not provided
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D014554 | Urination |
| ID | Term |
|---|---|
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Middle ear fluid, Urine.
| 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 |
| Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. | 12 Months |