Feasibility randomised multicentre, double-blind, double-dummy controlled trial of anakinra, an interleukin-1 receptor antagonist versus intramuscular methylprednisolone for acute gout attacks in patients with chronic kidney disease (ASGARD): protocol study.

INTRODUCTION: Acute gout occurs in people with chronic kidney disease, who are commonly older people with comorbidities such as hypertension, heart disease and diabetes. Potentially harmful treatments are administered to these vulnerable patients due to a lack of clear evidence. Newly available treatment that targets a key inflammatory pathway in acute gout attacks provides an opportunity to undertake the first-ever trial specifically looking treating people with kidney disease. This paper describes the protocol for a feasibility randomised controlled trial (RCT) comparing anakinra, a novel interleukin-1 antagonist versus steroids in people with chronic kidney disease (ASGARD). METHODS AND ANALYSIS: ASGARD is a two-parallel group double-blind, double-dummy multicentre RCT comparing anakinra 100 mg, an interleukin-1 antagonist, subcutaneous for 5 days against intramuscular methylprednisolone 120 mg. The primary objective is to assess the feasibility of the trial design and procedures for a definitive RCT. The specific aims are: (1) test recruitment and retention rates and willingness to be randomised; (2) test eligibility criteria; (3) collect and analyse outcome data to inform sample and power calculations for a trial of efficacy; (4) collect economic data to inform a future economic evaluation estimating costs of treatment and (5) assess capacity of the project to scale up to a national multicentre trial. We will also gather qualitative insights from participants. It aims to recruit 32 patients with a 1:1 randomisation. Information from this feasibility study will help design a definitive trial and provide general information in designing acute gout studies. ETHICS AND DISSEMINATION: The London-Central Ethics Committee approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER: EudraCT No. 2015-001787-19, NCT/Clinicalstrials.gov No. NCT02578394, pre-results, WHO Universal Trials Reference No. U1111-1175-1977. NIHR Grant PB-PG-0614-34090.

Rotavirus vaccination rate disparities seen among infants with acute gastroenteritis in Georgia.

OBJECTIVE: Rotavirus (RV) is one of the most common diarrheal diseases affecting children less than 5 years of age. RV vaccines have greatly reduced this burden in the United States. The purpose of this study was to determine possible disparities and socio-economic differences in RV vaccination rates. DESIGN: Children with acute gastroenteritis were enrolled. Stool was tested for presence of rotavirus using an enzyme immunoassay kit. Vaccination records were abstracted from the state immunization registry and healthcare providers to examine complete and incomplete vaccination status. Cases were identified as children receiving a complete RV dose series and controls were identified as children with incomplete RV doses. A logistic regression model was used to determine disparities seen amongst children with incomplete vaccination status. RESULTS: Racial differences between Black and white infants for RV vaccination rates were not significant when controlling for covariates (OR 1.15, 95% CI 0.74-1.78); however ethnicity (p-value .0230), age at onset of illness (p-value .0004), birth year (p-value < .0001), and DTaP vaccination status (p-value < .0001) were all significant in determining vaccination status for children. CONCLUSIONS: Racial disparities and socio-economic differences are not determinants in rotavirus vaccination rates; however, age and ethnicity have an effect on RV vaccine status.