Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in HIV-positive and HIV-negative Children in South Africa

GlaxoSmithKline1 site in 1 country265 target enrollmentMay 2009

ConditionsAcute Otitis Media

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Otitis Media
Sponsor: GlaxoSmithKline
Enrollment: 265
Locations: 1
Primary Endpoint: Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

May 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria for all subjects:
•Age: \>= 3 months and \< 5 years at the time of enrolment.
•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 24 hours.
•Subject will be included as a treatment failure case.
•Written informed consent obtained from parent or guardian prior to study start.
•Inclusion criteria for HIV-positive subjects:
•Documented HIV-positive status as given in subject's medical records. or

Exclusion Criteria

•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 72 hours prior to enrolment.
•Receiving antimicrobial prophylaxis for recurrent acute otitis media but excluding cotrimoxazole or isoniazid prophylaxis in HIV exposed children.
•Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous Otorrhoea.
•Children on antibiotics for acute otitis media who are clinically improving.

Outcomes

Primary Outcomes

Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.

Secondary Outcomes

Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
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 bacterial serotypes.
Antimicrobial susceptibility of different bacteria isolated from middle ear fluid samples as assessed by standard microbiological techniques.
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.