Publications by authors named "Mitsuaki Machida"
Article Synopsis
- The study aimed to find the best dose of sivopixant for treating refractory or unexplained chronic cough (RCC/UCC) through a phase 2b trial with various dosages compared to a placebo.
- Overall, while most patients completed the study, there were no statistically significant improvements in cough frequency or severity for any dose of sivopixant compared to placebo, although the 300 mg dose showed some promise.
- The trial indicated that sivopixant could lead to mild to moderate side effects, particularly taste disturbances, and emphasized the need for further research despite showing some potential benefits at the highest dosage.
Article Synopsis
- - The purinoceptor subtype P2X is important in the cough reflex and has been linked to taste disturbances; while gefapixant (an existing treatment) has low selectivity and causes taste issues, sivopixant is a new drug with higher selectivity for P2X receptors.
- - A clinical study involving 31 patients focused on the effects of sivopixant, administered for two weeks, assessing its efficacy in reducing cough and improving life quality, using a randomized, placebo-controlled crossover design.
- - Results showed that sivopixant significantly reduced cough frequency and improved health-related quality of life, with few mild side effects, including some taste disturbances in only 6.5% of participants. *
Purpose: Cefiderocol is a novel siderophore cephalosporin with potent activity against gram-negative bacteria, including multidrug-resistant strains. This Phase I study was conducted to assess the tolerability of single-ascending doses of cefiderocol (part 1) and the effect of cefiderocol on cardiac repolarization, assessed using the electrocardiographic corrected QT interval (QTcF) and other ECG parameters (part 2), in healthy adult subjects.
Methods: Part 1 was a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy adult male and female subjects.
Background: Carbapenem-resistant Gram-negative bacteria represent the highest priority for addressing global antibiotic resistance. Cefiderocol (S-649266), a new siderophore cephalosporin, has broad activity against Enterobacteriaceae and non-fermenting bacteria, such as Pseudomonas aeruginosa and Acinetobacter baumannii, including carbapenem-resistant strains. We assessed the efficacy and safety of cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infection in patients at risk of multidrug-resistant Gram-negative infections.
View Article and Find Full Text PDFBackground: Missing data can compromise inferences from clinical trials, yet the topic has received little attention in the clinical trial community. Shortcomings in commonly used methods used to analyze studies with missing data (complete case, last- or baseline-observation carried forward) have been highlighted in a recent Food and Drug Administration-sponsored report. This report recommends how to mitigate the issues associated with missing data.
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