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.
Whether adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis would result in a lower incidence of deep-vein thrombosis than pharmacologic thromboprophylaxis alone is uncertain. We randomly assigned patients who were considered adults according to the local standards at the participating sites (≥14, ≥16, or ≥18 years of age) within 48 hours after admission to an intensive care unit (ICU) to receive either intermittent pneumatic compression for at least 18 hours each day in addition to pharmacologic thromboprophylaxis with unfractionated or low-molecular-weight heparin (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control group). The primary outcome was incident (i.e., new) proximal lower-limb deep-vein thrombosis, as detected on twice-weekly lower-limb ultrasonography after the third calendar day since randomization until ICU discharge, death, attainment of full mobility, or trial day 28, whichever occurred first. A total of 2003 patients underwent randomization — 991 were assigned to the pneumatic compression group and 1012 to the control group. Intermittent pneumatic compression was applied for a median of 22 hours (interquartile range, 21 to 23) daily for a median of 7 days (interquartile range, 4 to 13). The primary outcome occurred in 37 of 957 patients (3.9%) in the pneumatic compression group and in 41 of 985 patients (4.2%) in the control group (relative risk, 0.93; 95% confidence interval [CI], 0.60 to 1.44; P=0.74). Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13). Among critically ill patients who were receiving pharmacologic thromboprophylaxis, adjunctive intermittent pneumatic compression did not result in a significantly lower incidence of proximal lower-limb deep-vein thrombosis than pharmacologic thromboprophylaxis alone. (Funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center; PREVENT ClinicalTrials.gov number, NCT02040103; Current Controlled Trials number, ISRCTN44653506.)
Artificial intelligence (AI) is a branch of science and engineering that focuses on the computational understanding of intelligent behavior. Many human professions, including clinical diagnosis and prognosis, are greatly useful from AI. Antimicrobial resistance (AMR) is among the most critical challenges facing Pakistan and the rest of the world. The rising incidence of AMR has become a significant issue, and authorities must take measures to combat the overuse and incorrect use of antibiotics in order to combat rising resistance rates. The widespread use of antibiotics in clinical practice has not only resulted in drug resistance but has also increased the threat of super-resistant bacteria emergence. As AMR rises, clinicians find it more difficult to treat many bacterial infections in a timely manner, and therapy becomes prohibitively costly for patients. To combat the rise in AMR rates, it is critical to implement an institutional antibiotic stewardship program that monitors correct antibiotic use, controls antibiotics, and generates antibiograms. Furthermore, these types of tools may aid in the treatment of patients in the event of a medical emergency in which a physician is unable to wait for bacterial culture results. AI’s applications in healthcare might be unlimited, reducing the time it takes to discover new antimicrobial drugs, improving diagnostic and treatment accuracy, and lowering expenses at the same time. The majority of suggested AI solutions for AMR are meant to supplement rather than replace a doctor’s prescription or opinion, but rather to serve as a valuable tool for making their work easier. When it comes to infectious diseases, AI has the potential to be a game-changer in the battle against antibiotic resistance. Finally, when selecting antibiotic therapy for infections, data from local antibiotic stewardship programs are critical to ensuring that these bacteria are treated quickly and effectively. Furthermore, organizations such as the World Health Organization (WHO) have underlined the necessity of selecting the appropriate antibiotic and treating for the shortest time feasible to minimize the spread of resistant and invasive resistant bacterial strains.
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.
Coronavirus disease 2019 (COVID-19) pandemic has had a significant impact on public mental health. Our objective was to assess prevalence of depression, anxiety, and stress among the general population in Saudi Arabia during this pandemic. A descriptive cross-sectional approach was used targeting all accessible populations in Saudi Arabia. Data were collected from participants using an electronic pre-structured questionnaire. Psychological impact was assessed using the Arabic version of Depression, Anxiety, and Stress Scale (DASS-21). A total of 1597 participants completed the survey. In total, 17.1% reported moderate to severe depressive symptoms; 10% reported moderate to severe anxiety symptoms; and 12% reported moderate to severe stress levels. Depression, anxiety, and stress were significantly higher among females, younger respondents, and health care providers. Depression was higher among smokers, singles, and non-working respondents. Anxiety was higher among those reporting contacts with COVID-19 positive cases, previously quarantined and those with chronic health problems. Our findings reaffirm the importance of providing appropriate knowledge and specialized interventions to promote the mental well-being of the Saudi population, paying particular attention to high-risk groups.
Nosocomial infections caused by Klebsiella pneumoniae and other Gram-negative organisms have emerged as a significant health problem especially in intensive care units (ICU). This study aims to examine K. pneumoniae infections in the ICU of Aseer Central Hospital and to determine their antimicrobial susceptibility and their relationship to patients' clinical outcomes. This is a retrospective observational study done in a tertiary care center in the Aseer region in Saudi Arabia. The study spanned from January 2018 to December 2019. Demographic, microbiologic, and patient outcomes were collected from 276 patients with various infections. Identification of isolates and in vitro susceptibility to 32 antimicrobial agents were done by the Vitek 2 automated system (bioMérieux, Marcy-l'Étoile, France). Prevalence of K. pneumoniae bacteria, their susceptibility to antimicrobials, and effect on clinical outcome were studied. Two hundred seventy-six K. pneumoniae were recovered from ICU patients with various infections. K. pneumoniae isolates (n=276) were collected mainly from the respiratory tract (61%) and K. pneumoniae represented 39% of the major causal agents of ICU infections, followed by Acinetobacter spp. (30%), Pseudomonas aeruginosa (10.0%), Escherichia coli (7%), and others (14%). The mortality among the 276 ICU patients was 33.3%; K. pneumoniae was connected to 42% of the cases and 67% of the total deaths were between 50 and 90 years of age. K. pneumoniae demonstrated high sensitivity and hence can be recommended for in vivo treatment for tigecycline (81%), cefazolin (77.2%), colistin (64.9%), and to a lesser extent norfloxacin (60%) and imipenem (55.5%). High resistance was detected for ampicillin (100%), extended-spectrum β-lactamases-sulbactam (ESBL-SCM) (100%), piperacillin (100%), and ceftazidime (92.5%). Resistance to carbapenems was elevated in ertapenem (65.2%) and meropenem (61.7%). The increase of K. pneumoniae represents a threat to ICU patients, although K. pneumoniae infections were results rather than the causes, as it was connected to almost half of the ICU mortalities. Tigecycline alone or in combination with colistin on high-dose regimens could be a more effective therapy for treating carbapenem-resistant K. pneumoniae infections.