It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843. Registered on 27 July 2016.

The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment.Trial registration: ClinicalTrials.gov,NCT02845843. Registered on 27 July 2016.

Medication errors (MEs) are among the most common types of medical errors and one of the most common and preventable causes of iatrogenic injuries. The aims of the present study were; (i) to determine the incidence and types of medication prescribing errors (MPEs), and (ii) to identify some potential risk factors in a pediatric inpatient tertiary care setting in Saudi Arabia.

One of the most unfortunate events toddlers may encounter during their early years of curiosity and experimentation is substance poisoning. The aim of the study was to evaluate the poison severity score and its associated factors among toddlers with orally ingested substances at a pediatrics emergency department (ED), central Saudi Arabia. A cross-sectional, poisoning report review between 2009&2011 was conducted. Exposures were patient characteristics (sex, age, body mass index, medical history) and incident characteristics (substance type, amount, form, witnessed or not, home remedy, arrival time to ED). Outcome was Poison Severity Score (PSS) that rates signs/symptoms of 11 body aspects on scale 0–4 (none, minor, moderate, severe, fatal). Inclusion criteria: age (1–3 years), previously healthy and oral exposure route. Bivariate analysis and multi-linear regression were conducted. Significance at p < 0.05. Eligible cases were 165/315(52 %). Males (58 %) and females (42 %) had normal BMI (70 %). Substances ingested were medications (60 %) and chemicals (40 %). Almost 85 % were witnessed incidents and 27 % received a home remedy (water, juices, dairy products, salt/sugar solutes, and/or manually induced vomiting). Delayed arrival (≥1 hour) was observed in 57 %. Composite mean PSS of total was (0.16 ± 0.21), and was highest at the gastrointestinal (GI) aspect (0.39 ± 0.63), metabolic balance (0.35 ± 0.60), and respiratory aspect (0.30 ± 0.61). Significantly associated factors with higher severity scores were: home remedies at the composite mean PSS (adj.p = 0.048), chemical poisoning at two aspects respiratory (adj.p = 0.047) and muscular (adj.p = 0.009) compared to medication poisoning. Unwitnessed incidents at the muscular aspect (adj.p = 0.026) compared to witnessed incidents; delayed arrival time to ED at three aspects GI (adj.p = 0.001), nervous system (adj.p = 0.014) and kidney (adj.p < 0.001). Parents are not recommended to provide any home remedy to their orally poisoned toddlers, but rather directly visit the ED. Physicians are expected to observe more severe clinical outcomes among toddlers with chemical poisoning, unwitnessed incidents, and delayed arrival times especially at the respiratory, GI, muscular, nervous and kidney aspects.

Background: Antibiotic prescriptions at emergency departments (ED) could be a primary contributing factor to the overuse of antimicrobial agents and subsequently antimicrobial resistance. The aim of this study was to describe the pattern of antibiotic prescriptions at an emergency department of a tertiary care hospital in Saudi Arabia. Methods: A cross-sectional study, based on a review of antibiotic prescriptions was conducted. All cases who visited the emergency department over a three-month period with a complaint of infection were analyzed in terms of patient characteristics (age, sex, infection type, and number of visits) and prescription characteristics (antibiotic category, spectrum, course and costs). The World Health Organization and International Network of Rational Use of Drugs prescribing indicators were presented. Descriptive and analytic statistics were applied. Results: A total of 36,069 ED visits were recorded during the study period, of which 45,770 drug prescriptions were prescribed, including 6,354 antibiotics. The average number of drugs per encounter was 1.26, while the percentage of encounters with a prescribed antibiotic was 17.6%. Among antibiotic prescriptions, the percentage of encounters with injection antibiotics was 15.2%. Almost 77% of antibiotics were prescribed by their generic names, and the percentage of antibiotics prescribed from the essential list was 100%. Conclusion: The average number of drugs per encounter in general and antibiotics per encounter in specific at this setting was lower than the standard value. However, the percentage of antibiotics prescribed by its generic name was less than optimal.

Background: The behavior of the general public and the adoption of precautionary measures during a pandemic determine the fate of the country in the absence of any specific cure. This study aimed to determine the public attitude and behavior responses to the COVID-19 pandemic in Saudi Arabia during movement restrictions, and the predictors of behavioral responses. Methods: A community-based cross-sectional study of 2470 adult individuals in Saudi Arabia, 17– 29 April 2020 was conducted via Survey Monkey, using an anonymous validated e-questionnaire. Data were collected on demographic characteristics, COVID-19-related attitudes, and behavioral responses in terms of; precautionary measures, preparedness, and self-quarantine activities, to be responded to by 4-point Likert scales. Multiple linear regression analyses were performed to identify the significant predictors of compliance with different behaviors. Significance was considered at p< 0.05. Results: Participants reported positive attitudes towards governmental actions (95%), self-hygiene (93.2%), social distancing (97.1%) and choice of healthy food (89.6%), and negative attitudes towards the current worldwide situation of the pandemic (81.0%) and hearing someone tested positive (77.8%) or died from COVID-19 (83.7%). High rates of compliance to behavior were reported by only 55.8% of participants in terms of precautionary measures (71.3%), preparedness (38.4%), and self-quarantine activities (46.1%). After adjusting for all possible confounders, the total attitude score was a significant predictor of the total scores of precautionary measures (t=12.01, p< 0.001), preparedness (t=9.29, p< 0.001), self-quarantine activities (t=12.05, p< 0.001), and overall behavior response (t=14.09, p< 0.001). Other significant predictors of higher overall behavior response scores were female gender (t=7.22, p< 0.001) and non-Saudi nationality (t=3.40, p< 0.001). Conclusion: This study provides baseline data on the behavioral response to the national COVID-19 pandemic in Saudi Arabia. The levels of compliance to behavior response and attitude to COVID-19 pandemic were less than satisfactory. Socio-demographics influence public behavior and protective health measures. COVID-19 awareness programs are recommended.