Acute Otitis MediaNCT01031082
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
An observational study of Acute Otitis Media, run by GlaxoSmithKline at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Middle ear fluid, nasopharyngeal aspirate and urine sample.
- Type of treatment
- Surgery or procedure
- How many people
- 265 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged >= 3 months and < 5 years seeking healthcare for the treatment of acute otitis media.
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in HIV-positive and HIV-negative Children in South Africa
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
- Being tested
- Middle ear fluid, nasopharyngeal aspirate and urine sample.
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle ear fluid, nasopharyngeal aspirate and urine sample.Procedure or surgery
Middle ear fluid, nasopharyngeal aspirate and urine sample collection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
Frequency of concurrent respiratory viral infection coinciding with the episode of acute otitis media.
The comparison of above endpoints in HIV-positive and HIV-negative subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031082
- Sponsor's protocol ID
- 112135
- Status last verified
- May 2010
- First submitted
- 10 Dec 2009
- Last updated
- 24 May 2010
- Results posted
- No
Publications
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.
PubMed 25923426
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in HIV-positive and HIV-negative Children in South Africa
- ClinicalTrials.gov ID
- NCT01031082
- Acronym / sponsor ID
- 112135
- Conditions
- Acute Otitis Media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-negative Group | – | Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.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. |
| HIV-positive Group | – | Procedure: Middle ear fluid, nasopharyngeal aspirate and urine sample.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. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged >= 3 months and < 5 years seeking healthcare for the treatment of acute otitis media.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle ear fluid, nasopharyngeal aspirate and urine sample.Middle ear fluid, nasopharyngeal aspirate and urine sample collection. | Procedure or surgery | HIV-negative Group, HIV-positive Group |
Primary outcome
Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.
8 secondary outcomes
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.
Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
Frequency of concurrent respiratory viral infection coinciding with the episode of acute otitis media.
The comparison of above endpoints in HIV-positive and HIV-negative subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
- Derived from this study: PubMed 25923426Madhi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Otitis Media, run by GlaxoSmithKline at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2010.