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Trial registered on ANZCTR


Registration number
ACTRN12611000383965
Ethics application status
Not yet submitted
Date submitted
12/04/2011
Date registered
13/04/2011
Date last updated
13/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Otitis Media Infectious Aetiology & Vaccine Impact Study
Scientific title
Prospective descriptive study of the infectious aetiology of otitis media and of nasopharyngeal bacterial flora of children in New Zealand under two different pneumococcal vaccination schedules. Multicentre Trial of under 3 year old children at Starship, Counties Manukau and Canterbury DHB's.
Secondary ID [1] 259982 0
NZ Ethics Committee: NTX/11/04/029
ADHB Research Committee: 5065
Universal Trial Number (UTN)
U111-1120-6956
Trial acronym
OMIVI (Otitis Media Infectious aetiology & Vaccination Impact)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Media 265606 0
Condition category
Condition code
Ear 265753 265753 0 0
Other ear disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjects (300 children <3y undergoing grommet insertion)Collection of Middle Ear Fluid (at time of grommet insertion)
Collection of Nasopharyngeal Swab (at time of Grommet insertion)

Comparison Group (150 children <3y undergoing elective surgery who on parental history have no significant history of ear disease)
Collection of Nasopharyngeal Swab (at time of general anaesthetic for non-ear related surgery)

Parental Questionnaire - administered to both subjects and comarison group on the day of surgery

This study will be performed as two Phases (Each phase as described above, under two different vaccination schedules):
Phase One: Starting April 2011, completion by Dec 31st 2011 (with possible extension to March 31st 2012 if target of 300 subjects not yet recruited). This will capture children vaccinated under the current PCV7 (7 valent pneumococcal vaccination) schedule.
Phase Two: Starting April 2013, completion Dec 2013 (with possible extension to March 2014 if target of 300 subjects not yet recruited). This will capture children vaccinated under the new schedule with PCV10 (10 valent pneumococcal vaccination) schedule.

Both Phases of the study will be performed in 3 centres:
- Starship Childrens Hospital ADHB (Auckland)
- Counties Manukau DHB (South Auckland)
- Canterbury DHB (Christchurch)
Intervention code [1] 264395 0
Not applicable
Comparator / control treatment
Collection of nasopharyngeal swabs of age matched children with a history of ear disease and without a history of ear disease (at the time of elective day stay surgery)
Control group
Active

Outcomes
Primary outcome [1] 266510 0
To describe infectious agents of Otitis Media in the middle ear of children under 3 years old
Timepoint [1] 266510 0
Middle ear sample will be collected at time of grommet insertion

Middle ear effusion will be diluted in approximately 1ml of sterile saline. The diluted middle ear effusion sample will be immediately transported to the participating laboratories.

The participating laboratory will immediately briefly Vortex sample (mix by centrifuge) then divide sample by sterile pipette. One portion of middle ear fluid sample will be immediately stored neat at -70degrees celsius for future molecular work. Stored fluid will be sent to Christchurch laboratory for detection of otopathogens by polymerase chain detection for S.pn, H.i and M.cat. For S.pn we will use an established PCR assay targeting the pneumolysin gene to detect all serotypes.

The second portion of sample will be cultured immediately using routine bacterial culture and antibiotic susceptibility techniques optimised for the detection of upper respiratory tract pathogens. Middle ear fluid will be cultured onto horse blood agar, chocolate agar and selective media for Spn (colistin nalidixic acid agar). After 24-48 hours of incubation (at 35?C in 5% CO2 for S.pn) colonies would be identified visually via colony morphology and haemolysis. Typical draughtsmen colonies with alpha haemolysis were further confirmed by sensitivity to optochin for S.pn and with X and V factor testing for Haemophilus influenzae in accordance with current laboratory methods.
Antimicrobial susceptibility testing would be performed by the Kirby-Bauer disc diffusion method. Paper discs impregnated with antibiotic are placed onto lawn culture then incubated with precise measurement of the zone of inhibition surrounding each disc

and minimum inhibitory concentration (MIC) interpretive breakpoints were determined.
Pure isolates of pathogens (S.pn, Mcat and H.i) would be stored in Cryobroth (Fort Richard Laboratory Ltd) at -70C for 6-12 months. All viable S.pn isolates would be sent to the Institute of Environmental Science and Research (ESR), Wellington NZ for serotyping via the Quellung reaction.
Primary outcome [2] 266511 0
To describe the nasopharyngeal carriage rates of known otopathogens in children with a history of otitis media and compare this group with children without a history of otitis media
Timepoint [2] 266511 0
Nasopharyngeal swabs will be collected at the time of grommet insertion (300 cases) or non-ear related surgery (150 in comparison group) for both phases.

The swabs will be cultured immediately using routine bacterial culture and antibiotic susceptibility techniques optimised for the detection of upper respiratory tract pathogens. Middle ear fluid will be cultured onto horse blood agar, chocolate agar and selective media for Spn (colistin nalidixic acid agar). After 24-48 hours of incubation (at 35?C in 5% CO2 for S.pn) colonies would be identified visually via colony morphology and haemolysis. Typical draughtsmen colonies with alpha haemolysis were further confirmed by sensitivity to optochin for S.pn and with X and V factor testing for Haemophilus influenzae in accordance with current laboratory methods.

Pure isolates of pathogens (S.pn, Mcat and H.i) would be stored in Cryobroth (Fort Richard Laboratory Ltd) at -70C for 6-12 months. All viable S.pn isolates would be sent to the Institute of Environmental Science and Research (ESR), Wellington NZ for serotyping via the Quellung reaction.

The results from each group will be analysed and compared by the study group statistician.
Secondary outcome [1] 273930 0
The proportion of vaccine related and non-vaccine related S.pneumoniae serotypes and H.influenzae isolated from middle ear samples and their antibiotic sensitivities.
Timepoint [1] 273930 0
Samples will be collected at the time of grommet insertion

See methods as described in Primary outcome methodology.

This data will be particularly interesting when comparing Phase One (PCV7 vaccinated children) with Phase Two (PCV10 Vaccinated Children).
Secondary outcome [2] 273931 0
The proportion of middle ear isolates from children with otitis prone conditions that are PCR positive for known otopathogens
Timepoint [2] 273931 0
Samples will be collected at the time of grommet insertion

See methods as described in Primary outcome methodology.

An analysis will be made between the culture positive results from the middle ear samples and the PCR positive results.

We will compare out results with a similar study that has been performed in Western Australia.

Eligibility
Key inclusion criteria
Elective ventilation tube (grommet) surgery (cases)
Elective non-ear related surgery (comparison group)
Minimum age
No limit
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cases:
Primary or secondary immune deficiency
Cystic fibrosis
Craniofacial anomalies
Subjects who have had one or more doses of PCV10 vaccination

Comparison Group:
History of recurrent acute otitis media
History of Glue Ear (Chronic Otitis Media)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 3380 0
New Zealand
State/province [1] 3380 0

Funding & Sponsors
Funding source category [1] 264860 0
Commercial sector/Industry
Name [1] 264860 0
GlaxoSmith Kline
Country [1] 264860 0
New Zealand
Primary sponsor type
Hospital
Name
Starship Children's Hospital - ADHB
Address
Park Road, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 263959 0
Commercial sector/Industry
Name [1] 263959 0
GlaxoSmith Kline
Address [1] 263959 0
Private Bag 106600
Downtown Auckland
Auckland 1143
Country [1] 263959 0
New Zealand
Other collaborator category [1] 251938 0
Hospital
Name [1] 251938 0
Counties Manukau DHB
Address [1] 251938 0
Manukau SuperClinic
PO Box 98743
Manukau City
Manukau 2241
Country [1] 251938 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266823 0
Northern X Regional Ethics Committee
Ethics committee address [1] 266823 0
Ethics committee country [1] 266823 0
Date submitted for ethics approval [1] 266823 0
22/03/2011
Approval date [1] 266823 0
Ethics approval number [1] 266823 0
NTX/11/04/029

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32473 0
Address 32473 0
Country 32473 0
Phone 32473 0
Fax 32473 0
Email 32473 0
Contact person for public queries
Name 15720 0
Dr Nikki Mills
Address 15720 0
Paediatric ENT Consultant
Starship Children's Hospital
Park Rd
Grafton
Auckland 1023
Country 15720 0
New Zealand
Phone 15720 0
+64 274488110
Fax 15720 0
Email 15720 0
nikki@adhb.govt.nz
Contact person for scientific queries
Name 6648 0
Dr Nikki Mills
Address 6648 0
Paediatric ENT Consultant
Starship Children's Hospital
Park Rd
Grafton
Auckland 1023
Country 6648 0
New Zealand
Phone 6648 0
+64 274488110
Fax 6648 0
Email 6648 0
nikki@adhb.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 336795-(Uploaded-02-07-2019-11-16-36)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.