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Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children | Clinical Trials | Clareo Health

COMPLETED

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

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

NCT01031082•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Documented HIV-positive status as given in subject's medical records. or
•Subjects referred from paediatric HIV clinic.
•Children who have been tested HIV-negative.
+2 more criteria

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.

Locations (1)

GSK Investigational Site

Soweto, Gauteng, South Africa

Key Dates

Start Date

May 1, 2009

Primary Completion Date

May 1, 2010

Completion Date

May 1, 2010

Last Updated

May 24, 2010

Enrollment

265

ACTUAL participants

Conditions

Acute Otitis Media

Interventions

Middle ear fluid, nasopharyngeal aspirate and urine sample.

PROCEDURE

Analgesic Ear Drops for Children With Acute Otitis Media

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Acute Otitis MediaPain

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UNKNOWN

Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

NCT02591563

Nasopharyngeal Colonization and Acute Otitis Media

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COMPLETEDNA

Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Analgesic Ear Drops for Children With Acute Otitis Media

Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years

Open-Label Study of OTO-201 for Treatment of AOMT

A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months