The purpose of this study is to identify and characterize the bacteria causing acute otitis media episode in HIV-positive and HIV-negative children (\>=3 months to \<5 years) in South Africa. Middle ear fluid sampling either by tympanocentesis or by careful sampling of spontaneous otorrhoea will be done; nasopharyngeal aspirate and urine sample will also be collected from the subjects.
Study Type
OBSERVATIONAL
Enrollment
265
Middle ear fluid, nasopharyngeal aspirate and urine sample collection.
GSK Investigational Site
Soweto, Gauteng, South Africa
Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.
Occurrence of bacterial serotypes.
Antimicrobial susceptibility of different bacteria isolated from middle ear fluid samples as assessed by standard microbiological techniques.
Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
Occurrence of spontaneous otorrhoea.
Occurrence of bacteria in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy.
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
Frequency of concurrent respiratory viral infection coinciding with the episode of acute otitis media.
The comparison of above endpoints in HIV-positive and HIV-negative subjects.
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