In the review article contributed by the authors to this journal in March of 2021, 91 clinical trials of ivermectin for COVID-19 from 27 countries around the world registered in public registries were described. At that time, 18 of the studies (13 being randomized controlled trials) had been published. Two years and nine months later, trial description enrollment has increased to 169 studies from 39 countries and includes 47 randomized controlled trials that have been peer-reviewed and published in medical journals. In addition to these registered trials, the results of 54 clinical trials not registered in public registries are also reported. This review provides an overview of these 223 clinical trials and summarizes and analyzes the results of 101 trials that have been reported.
In addition, as many as 27 systematic reviews and meta-analyses have been conducted on 69 articles from 24 countries in those trial results. Among them, 15 of the analyses demonstrated ivermectin efficacy, while 12 were unable to demonstrate efficacy. As a result of analyzing the differences between these meta-analyses, we concluded that COVID-19 itself, the target disease, has changed over time. Therefore, it is no longer appropriate as a target disease for meta-analysis, unlike other chronic diseases.
Among the study results provided for analysis in this review, several trials of importance were found to have serious errors or deviations in protocol violations: changes during the actual conduct of the study itself, blinding, placebo setting issues, and how papers were written. Furthermore, we are concerned about the spread of misinformation and/or disinformation regarding the execution and results of tests; a forthcoming review article will address this topic.
In the review article contributed by the authors to this journal in March of 2021, 91 clinical trials of ivermectin for COVID-19 from 27 countries around the world registered in public registries were described. At that time, 18 of the studies (13 being randomized controlled trials) had been published. Two years and nine months later, trial description enrollment has increased to 169 studies from 39 countries and includes 47 randomized controlled trials that have been peer-reviewed and published in medical journals. In addition to these registered trials, the results of 54 clinical trials not registered in public registries are also reported. This review provides an overview of these 223 clinical trials and summarizes and analyzes the results of 101 trials that have been reported.
In addition, as many as 27 systematic reviews and meta-analyses have been conducted on 69 articles from 24 countries in those trial results. Among them, 15 of the analyses demonstrated ivermectin efficacy, while 12 were unable to demonstrate efficacy. As a result of analyzing the differences between these meta-analyses, we concluded that COVID-19 itself, the target disease, has changed over time. Therefore, it is no longer appropriate as a target disease for meta-analysis, unlike other chronic diseases.
Among the study results provided for analysis in this review, several trials of importance were found to have serious errors or deviations in protocol violations: changes during the actual conduct of the study itself, blinding, placebo setting issues, and how papers were written. Furthermore, we are concerned about the spread of misinformation and/or disinformation regarding the execution and results of tests; a forthcoming review article will address this topic.
Invasive fungal and bacterial infections are becoming increasingly important concerns in infants hospitalized in neonatal intensive care units (NICUs). Obtaining information on airborne pathogens in the NICU is important for evaluating the risk of hospital-acquired infections (HAIs) and for implementing measures to prevent HAIs in the NICU. This study aimed to evaluate the distribution of culturable airborne fungal and bacterial species in indoor air from six different hospital NICUs in Chiba Prefecture, Japan. Bacterial and fungal isolation from the air was performed using a low-volume air sampler.
Fungi isolated from the samples were identified using molecular methods. The bacteria isolated from the samples were identified using matrix-assisted laser desorption time-of-flight mass spectrometry. A few pathogenic fungi, including Candida parapsilosis, were detected in the air samples. Staphylococcus spp., including methicillin-resistant Staphylococcus aureus, were mainly detected in the air samples. Based on the results of this study, the analysis of air samples in the NICU can be considered a good method for identifying the source of infection and preventing infection during outbreaks of fungi and resistant bacteria in the NICU.
REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia) is an international adaptive platform trial to identify optimal therapeutic management for community-acquired pneumonia including COVID-19. This manuscript describes an overview of REMAP-CAP with particular focus on the antibiotics and macrolide duration domains, both of which are being conducted in Japan.
In the antibiotic domain, patients with severe community-acquired pneumonia are eligible, and randomized to one of three interventions for initial antibiotic therapy: ceftriaxone plus macrolide, piperacillin tazobactam plus macrolide, or levofloxacin. In the macrolide duration domain, patients randomized to the above two interventions containing macrolide are further randomized to standard (3–5 days) or long-term (14 days) treatment regimen.
It is anticipated that adaptive platform trials will play a major role in evidence generation for infectious diseases. We hope that researchers in Japan will learn more about an adaptive platform directly through participation in these domains of REMAP-CAP.