Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children

Completed

• Conditions: Acute Otitis Media
• Interventions: Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.

• Registration Number: NCT01031082
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-14
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-20
• Last Update Posted: 2010-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-positive Group	Middle ear fluid, nasopharyngeal aspirate and urine sample.	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.
HIV-negative Group	Middle ear fluid, nasopharyngeal aspirate and urine sample.	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇿🇦 Soweto, Gauteng, South Africa