Clinical trial NCT01031082: Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in HIV-positive and HIV-negative Children in South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Otitis Media
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 265
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged \>= 3 months and \< 5 years seeking healthcare for the treatment of acute otitis media.

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.


Eligibility 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.

Primary outcomes:
measure: Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.
Secondary outcomes:
measure: Occurrence of bacterial serotypes.
measure: Antimicrobial susceptibility of different bacteria isolated from middle ear fluid samples as assessed by standard microbiological techniques.
measure: Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
measure: Occurrence of spontaneous otorrhoea.
measure: Occurrence of bacteria in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy.
measure: Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
measure: Frequency of concurrent respiratory viral infection coinciding with the episode of acute otitis media.
measure: The comparison of above endpoints in HIV-positive and HIV-negative subjects.
Other outcomes:
Locations:
city: Soweto
country: South Africa
facility: GSK Investigational Site
state: Gauteng
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.