ACTRN12608000424303RecruitingPhase 3
A double blind placebo-controlled randomized clinical trial of the use of oral azithromycin in Aboriginal children between 6 months and 30 months of age presenting with asymptomatic acute otitis media without perforation
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 6 Months to 30 Months (—)
- Sex
- All
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
Investigators
Similar Trials
Completed
Not Applicable
A clinical trial to evaluate efficacy and safety of the study drug Neuroroj in treatment of painful Peripheral Diabetic Neuropathy (PDN)CTRI/2019/04/018678BigBrother Nutra Care Pvt Ltd50
Not yet recruiting
Not Applicable
Clinical trial of hair vitamin gummies to improve hair and nail healthCTRI/2023/03/050199Mosaic Wellness Pvt Ltd
Completed
Not Applicable
The Probiotics for Antibiotic Associated Diarrhoea (PAAD) study in care homes: determining the effect of probiotics on antibiotic associated diarrhoeaISRCTN25324586Cardiff University (UK)400
Completed
Not Applicable
A double-blind placebo-controlled randomised clinical trial assessing the efficacy and safety of a novel herbal formulation for weight loss in an Australian population of healthy adults who are overweight.OverweightAlternative and Complementary Medicine - Herbal remediesACTRN12621000470897Southern Cross University110
Recruiting
Phase 3
A study in subjects with Symptomatic genetic heart disease comparing sponsors drug Mavacamten with dummy drug.CTRI/2023/10/058870MyoKardia, Inc.