Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
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ClinicalTrials.gov Identifier: NCT01031082 |
Recruitment Status
:
Completed
First Posted
: December 14, 2009
Last Update Posted
: May 24, 2010
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Condition or disease | Intervention/treatment |
---|---|
Acute Otitis Media | Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample. |
Study Type : | Observational |
Actual Enrollment : | 265 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in HIV-positive and HIV-negative Children in South Africa |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |
Group/Cohort | Intervention/treatment |
---|---|
HIV-negative Group
This group is sub-divided into two sub-groups. One sub-group includes HIV-negative/ presumed negative subjects with a new episode of acute otitis media who have not yet received antibiotic therapy for the episode and the other sub-group includes HIV-negative/ presumed negative subjects with treatment failure who have had a diagnosis of acute otitis media and showed no clinical improvement within 48-72 hours of antibiotic treatment.
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Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.
Middle ear fluid, nasopharyngeal aspirate and urine sample collection.
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HIV-positive Group
This group is sub-divided into two sub-groups. One sub-group includes HIV-positive subjects with a new episode of acute otitis media who have not yet received antibiotic therapy for the episode and the other sub-group includes HIV-positive subjects with treatment failure who have had a diagnosis of acute otitis media and showed no clinical improvement within 48-72 hours of antibiotic treatment.
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Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.
Middle ear fluid, nasopharyngeal aspirate and urine sample collection.
|
- 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.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 3 Months to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
- Subjects referred from paediatric HIV clinic.
Inclusion criteria for HIV-negative subjects (including presumed negative children)
- Children who have been tested HIV-negative.
- Children whose mothers volunteer to have tested HIV-negative whilst pregnant with the index case and the child is free to any World Health Organization Grade II stigmata of HIV/acquired immunodeficiency syndrome.
- Children who do not fulfil the World Health Organization staging for HIV infection / immunosuppression.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031082
South Africa | |
GSK Investigational Site | |
Soweto, Gauteng, South Africa, 2013 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT01031082 History of Changes |
Other Study ID Numbers: |
112135 |
First Posted: | December 14, 2009 Key Record Dates |
Last Update Posted: | May 24, 2010 |
Last Verified: | May 2010 |
Additional relevant MeSH terms:
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |