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

NCT01031082 | Completed

• 1 other identifier: 112135
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• Occurrence of bacterial serotypes.

• Antimicrobial susceptibility of different bacteria isolated from middle ear fluid samples as assessed by standard microbiological techniques.

• Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.

• 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.

Study Arms (2)

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.

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.

Interventions

Middle ear fluid, nasopharyngeal aspirate and urine sample. PROCEDURE

Middle ear fluid, nasopharyngeal aspirate and urine sample collection.

HIV-negative Group; HIV-positive Group

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Soweto, Gauteng, 2013, South Africa

Location

Related Publications (1)

• Madhi SA, Govender N, Dayal K, Devadiga R, Van Dyke MK, van Niekerk N, Cutland CL, Adrian PV, Nunes MC. Bacterial and Respiratory Viral Interactions in the Etiology of Acute Otitis Media in HIV-infected and HIV-uninfected South African Children. Pediatr Infect Dis J. 2015 Jul;34(7):753-60. doi: 10.1097/INF.0000000000000733.

  PMID: 25923426 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Middle ear fluid, nasopharyngeal aspirate and urine.

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 24, 2010

Record last verified: 2010-05

Locations

ZA (1)