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

Acute Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031082
• Other study ID #: 112135
• Status: Completed
• Phase: N/A
• First received: December 10, 2009
• Last updated: May 20, 2010
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Procedure:
• Middle ear fluid, nasopharyngeal aspirate and urine sample.
Middle ear fluid, nasopharyngeal aspirate and urine sample collection.

Locations

Country	Name	City	State
South Africa	GSK Investigational Site	Soweto	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.			No
Secondary	Occurrence of bacterial serotypes.			No
Secondary	Antimicrobial susceptibility of different bacteria isolated from middle ear fluid samples as assessed by standard microbiological techniques.			No
Secondary	Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.			No
Secondary	Occurrence of spontaneous otorrhoea.			No
Secondary	Occurrence of bacteria in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy.			No
Secondary	Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.			No
Secondary	Frequency of concurrent respiratory viral infection coinciding with the episode of acute otitis media.			No
Secondary	The comparison of above endpoints in HIV-positive and HIV-negative subjects.			No