Antibtiotics for Asymptomatic Acute Otitis Media

Phase 3

Recruiting

• Conditions: Acute otitis media without perforation; Ear - Other ear disorders

• Registration Number: ACTRN12608000424303
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Informed consent obtained and signed

2. All Aboriginal children aged 6 months and 30 months of age on the date of randomisation who are resident in participating communities will be eligible to be screened for asymptomatic acute otitis media without perforation.

3. The following inclusion criteria for the randomized controlled trial (RCT) will be applied to children diagnosed with asymptomatic acute otitis media:
a.) A bulging tympanic membrane.
b.) No associated symptoms at the time of diagnosis (including ear pain or fever).

4. Children who have a diagnosis of asymptomatic acute otitis media who are able to attend the clinic for follow up visits at day 7, day 14 and day 28.

Exclusion Criteria

1. Acute otitis media with ear pain or fever
2. Acute otitis media with recent onset of perforation and discharge (within 7 days)
3. Chronic suppurative otitis media
4. Previously been randomised into this study
5. Have received antibiotics in the previous 7 days (not including topical antibiotics)
6. A more severe illness requiring antibiotics
7. Azithromycin allergy
8. Immunodeficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical failure (All): Proportion of children with bulging or middle ear discharge at 14 days or withdrawn due to complications or side effects. All children who are lost to follow up are considered clinical failures.[14 days after commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Proportion of children with bulging or middle ear discharge or withdrawn due to complications or side effects. Not including children who are lost to follow up.[Day 0, 7, 14 and 30];Proportion of children who develop an illness requiring additional medical treatment[Day 0, 7, 14 and 30];Proportion of children who develop an illness requiring cessation of prescribed antibiotics[Between Day 0 and day 30];Proportion of children who have no improvement in other conditions recorded like skin sores and rhinosinusitis[Day 7, 14 and 30];Microbiological outcomes including carriage and antibiotic resistance of Streptococcus pneumoniae and Haemophilus influenzae[Day 0, 7, 14 and 30];Comparison of two treatment groups for proportion of children with unresolved bulging at 7 days (on treatment assessment)[Day 7 after commencement of intervention];Comparison of two treatment groups for proportion of children with unresolved bulging at 30 days (end of follow up assessment)[Day 30 after commencement of intervention]