A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol

DiscussionIt is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.Trial registrationName of Registry: ISCRTNRegistration Number:ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data SetDate of Registration: 24 April 2018Name of Registry: EudraCTRegistration Number: 2017-003635-10Date of Registration: 6 September 2017
Source: Trials - Category: Research Source Type: clinical trials