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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective study - detecting incidence and recovery of impaired inner ear function with Gentamicin use
Scientific title
Prospective detection of vestibular abnormalities resulting from the administration of Gentamicin and documentation of their subsequent recovery.
Secondary ID [1] 273522 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gentamicin vestibulotoxicity 279260 0
Sepsis treated with Gentamicin 286458 0
Condition category
Condition code
Ear 279467 279467 0 0
Other ear disorders
Neurological 285563 285563 0 0
Other neurological disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Impairment of the vestibulo-ocular reflex following the administration of Gentamicin. This will be monitored daily, ideally pre-treatment, during the course of all IV treated patients with ANY dose of Gentamicin and at 7 days following completion of treatment. Recovery of any defecit will be monitored for up to 6 months in patients who show signs of impaired vestibular function.
Intervention code [1] 285163 0
Not applicable
Comparator / control treatment
No control (observational study)
Control group

Primary outcome [1] 286029 0
To detect the incidence of vestibulotoxicity of Gentamicin. This will be done by measuring the VOR velocity gain on the head impulse test with video oculograpy. This involves bedside testing with motion sensing goggles that measure eye velocity and head velocity during head rotation. This test involves the examiner rotating the patients head while they attempt to fixate on a point on the wall. This test takes approximately 3 minutes with 12 minutes of set up. A gain less than that establised in normative data of 0.76 will be regarded as abnormal.
Timepoint [1] 286029 0
Daily during the course of treatment with Gentamicin, and continuing daily until 1 week after the termination of the course of Gentamicin therapy. Gentamicin toxicity will be measured by a decrease in the VOR gain on the head impulse test with video oculograpy.
Primary outcome [2] 286123 0
To assess the recovery of the VOR gain in affected patients who demonstrate vestibular toxicity up to and including one week post cessation of treatment. Through testing as described above in primary outcome 1.
Timepoint [2] 286123 0
Weekly - biweekly for one month following the end of the course of Gentamicin, and once monthly subsequently, for up to 6 months or when the VOR shows complete recovery
Secondary outcome [1] 295019 0
Timepoint [1] 295019 0

Key inclusion criteria
Participants must: be able to give consent prior to or while being treated at Wellington Hospital or Hutt Valley Hospital. The only inclusion criteria at day 1 will be treatment or pending treatment with IV Gentamicin within 24 hrs of measurement of the VOR gain.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients so unwell that they do not wish to have their head moved or who decline testing or who are regarded by the examiner as being too ill to adequately co-operate.

Study design
Natural history
Defined population
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3977 0
New Zealand
State/province [1] 3977 0

Funding & Sponsors
Funding source category [1] 284361 0
Name [1] 284361 0
Capital and Coast District Health Board (CCDHB)
Address [1] 284361 0
Dr Stuart Mossman
Neurology Department
Clinical Measurement Unit - Level 2
Wellington Hospital
Riddiford Street
Wellington 6002
New Zealand
Country [1] 284361 0
New Zealand
Funding source category [2] 285235 0
Name [2] 285235 0
Wellington Hospital
Address [2] 285235 0
Wellington Hospital
Riddiford Street
Wellington 6002
New Zealand
Country [2] 285235 0
New Zealand
Primary sponsor type
Capital and Coast District Health Board (CCDHB)
Wellington Hospital
Riddiford Street
Wellington 6002
New Zealand
New Zealand
Secondary sponsor category [1] 283301 0
Name [1] 283301 0
Address [1] 283301 0
Country [1] 283301 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286309 0
Multi-Region Ethics Committee
Ethics committee address [1] 286309 0
PO Box 5013
Wellington 6011
New Zealand
Ethics committee country [1] 286309 0
New Zealand
Date submitted for ethics approval [1] 286309 0
Approval date [1] 286309 0
Ethics approval number [1] 286309 0

Brief summary
Gentamicin can have toxic effects on the inner ear which lessen an individual’s sense of spatial orientation and balance. The aim of this study is to investigate the incidence of this form of toxicity, and to investigate to what extent recovery is possible. This is done by recording eye movements, which have characteristic properties when movement sensors in the inner ear are non-functional.
This study will use video-oculography to enable an objective serial recording of the eye movement abnormality. In selected patients, the eye movements will be recorded over 6 months to observe recovery. This will provide information on how quickly the vestibular-ocular reflex (VOR) function recovers.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33440 0
Address 33440 0
Country 33440 0
Phone 33440 0
Fax 33440 0
Email 33440 0
Contact person for public queries
Name 16687 0
Stuart Mossman
Address 16687 0
Wellington Hospital
Riddiford St
Wellington 6002
Country 16687 0
New Zealand
Phone 16687 0
+64 27 873 6086
Fax 16687 0
+64 4 562 8009
Email 16687 0
Contact person for scientific queries
Name 7615 0
Stuart Mossman
Address 7615 0
Department Neurology
Wellington Hospital
Riddiford St
Wellington 6002
Country 7615 0
New Zealand
Phone 7615 0
Fax 7615 0
Email 7615 0

No information has been provided regarding IPD availability
Summary results
No Results