Australian Clinical Trials

Broad Health Condition Ear

Specific Health ConditionOther ear disorders

Trial FocusTreatment

Recruitment Details

Recruitment status
Recruiting

Recruitment State
WA

Hospital
St John of God Hospital, Subiaco - Subiaco
Subiaco Private Hospital - Subiaco
South Perth Hospital - South Perth
Perth Children's Hospital - Nedlands
St John of God Hospital, Murdoch - Murdoch

Postcode
6008 - Subiaco
6151 - South Perth
6009 - Nedlands
6150 - Murdoch

Anticipated date of first participant enrolment15/11/2019

Anticipated date of last participant enrolment1/10/2022

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Trial summary

This study will be a Phase IIB trial to look at the safety, tolerability and acceptability of the off-licence use of Dornase alfa into the ear post-ventilation tube insertion ("grommets") in children with chronic otitis media with effusion ("glue ear") and recurrent acute otitis media.  We believe that DNA plays a role in maintaining an infectious reservoir in which bacteria can form biofilms and be protected from clearance from the middle ear space. Targeting this DNA scaffolding may improve bacterial clearance from the middle ear and render those bacteria present more susceptible to antimicrobial treatments and the host immune response.  
From earlier research in our laboratory, we expect that Dornase alfa will help to increase effectiveness of treating middle ear infections and stop new infections from occurring. This would help reduce the number of children who need to have repeat grommet surgeries.

Key inclusion criteria

1. Aged 6 months to less than 5years of age.
2. Undergoing surgery for ventilation tube insertion for recurrent acute otitis media or chronic otitis media with effusion, either unilateral or bilateral, which will be performed by a collaborating ear, nose and throat (ENT) surgeon.  
N.B.  participants undergoing concurrent adenoidectomy and/or tonsillectomy are permitted to participate.
4. Has either a current medically confirmed unilateral or bilateral middle ear effusion that has been present for 3 months or longer and/or had 3 episodes of medically confirmed acute otitis media in the previous 6 months or 4 or more episodes in the previous 12 months.
5. Considered to be generally healthy as established by medical history before entering the study, excluding medical conditions listed in inclusion criterion 3.  
N.B. The participant must also not meet exclusion criterion 8. 
6. Parent/legal guardian has given written informed consent and is willing and able to comply with the scheduled visits and study procedures. This includes access to a telephone for surveillance contacts.
7. Is available for the entire study period.

Minimum age6 Months

Maximum age4 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

1. Has a diagnosed sensorineural hearing loss, cystic fibrosis, a craniofacial disorder or immotile cilia syndrome.
2. Has a confirmed or suspected immunosuppressive or immunodeficient condition.
3. Has a suspected or diagnosed genetic syndrome or chromosomal disorder.
4. Has experienced an allergic reaction to protein of Chinese Hamster Ovary origin.
5. Has experienced an allergic reaction or has a contra-indication to ciprofloxacin.
6. Does not have access to a refrigerator to store the 5 day course of study medication that will be administered to the participant at home by the parent/legal guardian.
7. Has received any investigational or non-registered drugs, vaccines or devices within 6 months of study visit 1 (day of surgery) or planned administration during the entire study period.
8. Any other significant acute or chronic medical condition that in the opinion of the investigator may interfere with the interpretation of study results or place the participant at increased risk if they participate in the study.