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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014