Watchful Waiting Compared With Immediate Antibiotics for Urban Aboriginal and Torres Strait Islander Children With Uncomplicated Acute Otitis Media (WATCH): A Non-Inferiority Randomised Controlled Trial
In brief
Immediate antibiotics improve 7-day cure rates by roughly six percent over watchful waiting
In this non-inferiority trial of 263 urban Aboriginal and Torres Strait Islander children with uncomplicated acute otitis media, 60% of those given immediate antibiotics were symptom-free by day 7 versus 54% with watchful waiting-a six-point difference that fell short of the pre-specified non-inferiority margin. Antibiotics reduced early diarrhoea but increased analgesic use; larger studies are needed to confirm safety and efficacy.
- Journal
- The Medical journal of Australia (Q1)
- Published
- 1 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Jennifer S Reath, Hasantha Gunasekera, Sanja Lujic, Amanda J Leach, Letitia Campbell, Robyn Walsh, et al.
- PMID
- 42592875
- DOI
- 10.5694/mja2.70260
Why clinicians should know about it
- Picked for Otorhinolaryngology (top studies of the week, 16 August 2026): Non-inferiority RCT, acute otitis media in children
- Picked for Pediatrics and Child Health (paper of the day, 16 August 2026): Watchful waiting vs immediate antibiotics for acute otitis media in
Abstract
OBJECTIVE: Determine whether watchful waiting is non-inferior to immediate oral antibiotics for uncomplicated acute otitis media among urban Aboriginal and Torres Strait Islander children. STUDY TYPE: Non-inferiority unblinded randomised controlled trial. SETTING AND PARTICIPANTS: Eight Aboriginal Medical Services across three Australian states and territories between 25 August 2014 and 2 June 2023. Children (aged 1.5-16 years) with type B tympanograms and bulging tympanic membrane or acute pain/irritability were randomised by site and age (1.5-6 years and 7-16 years), with stratification using randomly allocated, permuted blocks of four and six in length. MAIN OUTCOME MEASURES: Watchful waiting compared with immediate oral antibiotics using modified intention-to-treat (using only available data) and per-protocol analyses of Day 7 clinical resolution with non-inferiority threshold set at 10 percentage points. RESULTS: Children were randomly allocated to watchful waiting (134), six of whom were lost to follow-up or immediate antibiotics (129) with three lost to follow-up. Resolution occurred in 57/106 (53.8%) watchful waiting and 68/113 (60.2%) immediate antibiotic group of those with complete Day 7 data (-6.4 percentage points difference; 90% confidence interval [CI], -17.4 to 4.6) (modified intention-to-treat analysis). Per-protocol analysis similarly demonstrated reduced resolution in the watchful waiting group (49/97; 50.5%) compared with immediate antibiotics (67/112; 59.8%) with -9.3 percentage points difference (90% CI, -20.6 to 2.0). There was less Day 3 diarrhoea in watchful waiting (3/90; 3.3%) than in the immediate antibiotic group (13/93 [14.0%]; -10.7 percentage points difference; 95% CI, -18.6 to -2.7) but no other differences in vomiting, diarrhoea or rash (Days 3-14). Day 7 analgesia use was higher in the watchful waiting (53/107 [49.5%]) than immediate antibiotic group (37/116 [31.9%]; 17.6 percentage points difference; 95% CI, 4.9 to 30.1). There were no intervention-related severe adverse events or perforations. CONCLUSION: Although our results are numerically similar to those reported in other low-risk populations and no unexpected safety signals were observed in the watchful waiting arm, non-inferiority was not established. Larger, adequately powered trials are required to determine whether watchful waiting is non-inferior in this population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN#12613001068752.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.