ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Ear

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]

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]

To describe infectious agents of Otitis Media in the middle ear of children under 3 years old

Timepoint [1]

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]

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]

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]

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]

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]

The proportion of middle ear isolates from children with otitis prone conditions that are PCR positive for known otopathogens

Timepoint [2]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

GlaxoSmith Kline

Address [1]

Private Bag 106600
Downtown Auckland
Auckland 1143

Country [1]

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]

Commercial sector/Industry

Name [1]

GlaxoSmith Kline

Address [1]

Private Bag 106600
Downtown Auckland
Auckland 1143

Country [1]

New Zealand

Other collaborator category [1]

Hospital

Name [1]

Counties Manukau DHB

Address [1]

Manukau SuperClinic
PO Box 98743
Manukau City
Manukau 2241

Country [1]

New Zealand

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

22/03/2011

Approval date [1]

Ethics approval number [1]

NTX/11/04/029

Summary

Brief summary

This study aims to describe infectious agents of rAOM and OME in the middle ear of children with a history of rAOM or OME requiring insertion of tympanostomy tubes. We also aim to describe the nasopharyngeal carriage rates of known otopathogens in children with a history of otitis media. We will run the study as two phases: 300 children who have been vaccinated under the current PCV7 schedule, and to repeat the study after introduction of the PCV10 vaccination (starting collection in 2013)

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Nikki Mills

Address

Paediatric ENT Consultant
Starship Children's Hospital
Park Rd
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 274488110

Fax

[email protected]

Contact person for scientific queries

Name

Dr Nikki Mills

Address

Paediatric ENT Consultant
Starship Children's Hospital
Park Rd
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 274488110

Fax

[email protected]

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes			336795-(Uploaded-02-07-2019-11-16-36)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically