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FeBRILe3– Fever, Blood cultures and Readiness for discharge in Infants Less than 3 months’ old

Tom Snelling BMBS DTMH GDipClinEpid PhD FRACP Head, Infectious Disease Implementation Research 08 6319 1817 tom.snelling@thekids.org.au Head,

Prediction of Causative Pathogen of Osteomyelitis Using Bayesian Network Modelling

Asha Christopher Tom Bowen Blyth Snelling BA MBBS DCH FRACP PhD GAICD FAHMS OAM MBBS (Hons) DCH FRACP FRCPA PhD BMBS DTMH GDipClinEpid PhD FRACP Head

The NICE GUT Trial

Tom Snelling BMBS DTMH GDipClinEpid PhD FRACP Head, Infectious Disease Implementation Research 08 6319 1817 tom.snelling@thekids.org.au Head,

The ORVAC Trial - A phase IV, double-blind, randomised, placebo-controlled clinical trial to optimise the delivery of RV1 rotavirus vaccine to Northern Territory Aboriginal infants

Tom Snelling BMBS DTMH GDipClinEpid PhD FRACP Head, Infectious Disease Implementation Research 08 6319 1817 tom.snelling@thekids.org.au Head,

Whole-of-Life Inclusion in Bayesian Adaptive Platform Clinical Trials

There is a recognized unmet need for clinical trials to provide evidence-informed care for infants, children and adolescents. This Special Communication outlines the capacity of 3 distinct trial design strategies, sequential, parallel, and a unified adult-pediatric bayesian adaptive design, to incorporate children into clinical trials and transform this current state of evidence inequity. A unified adult-pediatric whole-of-life clinical trial is demonstrated through the Staphylococcus aureus Network Adaptive Platform (SNAP) trial.

Acute haemoptysis, fever and abdominal pain in an adolescent from northern Australia

Christopher Asha André Dr Anita Blyth Bowen Schultz Campbell MBBS (Hons) DCH FRACP FRCPA PhD BA MBBS DCH FRACP PhD GAICD FAHMS OAM MBChB, PhD, FRACP

Approaches to prioritising research for clinical trial networks: a scoping review

Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders.

The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February – August 2021

To assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer–BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia.

Study protocol for controlled human infection for penicillin G against Streptococcus pyogenes: a double-blinded, placebo-controlled, randomised trial to determine the minimum concentration required to prevent experimental pharyngitis (the CHIPS trial)

Regular intramuscular benzathine penicillin G injections have been the cornerstone of rheumatic heart disease (RHD) secondary prophylaxis since the 1950s. As the pharmacological correlate of protection remains unknown, it is difficult to recommend changes to this established regimen. Determining the minimum effective penicillin exposure required to prevent Streptococcus pyogenes infection will accelerate development of new long-acting penicillins for RHD prevention as well as inform opportunities to improve existing regimens. The CHIPS trial will address this knowledge gap by directly testing protection afforded by different steady state plasma concentrations of penicillin in an established model of experimental human S. pyogenes pharyngitis.

Protocol for establishing a core outcome set for evaluation in studies of pulmonary exacerbations in people with cystic fibrosis

Pulmonary exacerbations are associated with increased morbidity and mortality in people with cystic fibrosis (CF). There is no consensus about which outcomes should be evaluated in studies of pulmonary exacerbations or how these outcomes should be measured.