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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01031082
First received: December 10, 2009
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Acute Otitis Media
Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of bacterial serotypes. [ Designated as safety issue: No ]
  • Antimicrobial susceptibility of different bacteria isolated from middle ear fluid samples as assessed by standard microbiological techniques. [ Designated as safety issue: No ]
  • Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media. [ Designated as safety issue: No ]
  • Occurrence of spontaneous otorrhoea. [ Designated as safety issue: No ]
  • Occurrence of bacteria in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy. [ Designated as safety issue: No ]
  • Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. [ Designated as safety issue: No ]
  • Frequency of concurrent respiratory viral infection coinciding with the episode of acute otitis media. [ Designated as safety issue: No ]
  • The comparison of above endpoints in HIV-positive and HIV-negative subjects. [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle ear fluid, nasopharyngeal aspirate and urine.


Enrollment: 265
Study Start Date: May 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.
Middle ear fluid, nasopharyngeal aspirate and urine sample collection.
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.
Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.
Middle ear fluid, nasopharyngeal aspirate and urine sample collection.

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged >= 3 months and < 5 years seeking healthcare for the treatment of acute otitis media.

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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031082

Locations
South Africa
GSK Investigational Site
Soweto, Gauteng, South Africa, 2013
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT01031082     History of Changes
Other Study ID Numbers: 112135
Study First Received: December 10, 2009
Last Updated: May 20, 2010
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 20, 2014