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...
Source: Trials - June 2, 2020 Category: Research Source Type: clinical trials

An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial
In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China ’s primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages.MethodsWe will use a parallel-group, cluster-randomised, controlled, superiority trial with blinded outcome evaluation but unblinded treatment (providers and patients). We will randomise 34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio). In the cont...
Source: Trials - May 11, 2020 Category: Research Source Type: clinical trials

How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
Condition:   Ventilator Associated Pneumonia Intervention:   Behavioral: Enhanced hygiene measures Sponsor:   Hôpital Universitaire Fattouma Bourguiba Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 16, 2020 Category: Research Source Type: clinical trials

How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
Condition:   Ventilator Associated Pneumonia Intervention:   Behavioral: Enhanced hygiene measures Sponsor:   Hôpital Universitaire Fattouma Bourguiba Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 16, 2020 Category: Research Source Type: clinical trials

Shortening antibiotic duration in the treatment of acute cholangitis: rationale and study protocol for an open-label randomized controlled trial
DiscussionThis trial is expected to reveal whether SCT is non-inferior to conventional LCT or not, and may provide evidence that one can shorten the treatment duration for acute cholangitis for the benefit of patients.Trial registrationUniversity Hospital Medical Information Network,UMIN000028382. Registered on 30 August 2017. (Source: Trials)
Source: Trials - January 16, 2020 Category: Research Source Type: clinical trials

A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high-risk young children with non-bloody diarrhoea in low resource settings: the Antibiotics for Children with Diarrhoea (ABCD) trial protocol
DiscussionExpanding the treatment of acute watery diarrhoea in high-risk children to include an antibiotic may offer an opportunity to reduce deaths. These benefits may result from direct antimicrobial effects on pathogens or other incompletely understood mechanisms including improved nutrition, alterations in immune responsiveness or improved enteric function. The expansion of indications for antibiotic use raises concerns about the emergence of antimicrobial resistance both within treated children and the communities in which they live. ABCD will monitor antimicrobial resistance. The ABCD trial has important policy impli...
Source: Trials - January 12, 2020 Category: Research Source Type: clinical trials

Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? Protocol for a feasibility study
DiscussionThis feasibility study with embedded interviews will inform the planning and sample size calculation of an adequately powered trial to definitively determine whether cranberry helps to alleviate the symptoms of acute uncomplicated UTIs in women and whether it can safely reduce antibiotic use.Trial registrationISRCTN registry, ID:10399299. Registered on 24 January 2019. (Source: Trials)
Source: Trials - December 22, 2019 Category: Research Source Type: clinical trials

Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol
This study is a randomized, double-blind, multicenter, active-controlled, clinical trial. Adult patients aged 18 years or older who have end-stage kidney disease and are undergoing PD will be enrolled at three PD Centers in Thailand. A total of 354 PD patients will be randomly assigned to either the 2% chlorhexidine gluconate-impregnated patch, mupirocin ointment, or usual exit-site care with normal saline dressing according to a computer-generated random allocation sequence. Participants will be followed until discontinuation of PD or completion of 24  months. The primary study outcomes are time to first PD-related infe...
Source: Trials - December 18, 2019 Category: Research Source Type: clinical trials