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BackgroundComplicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.MethodsIn this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).ResultsIn the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.ConclusionsTigecycline was generally safe and effective in the treatment of cSSSIs.Trial registrationClinicalTrials.gov NCT00368537

This study aims to examine the impact of the COVID-19 outbreak on fertility across countries. To achieve this, fertility decline rates were calculated for each country before and after the COVID-19 epidemic, and the correlation between these rates and various demographic and socioeconomic variables was analyzed. The study data were obtained from multiple sources and subjected to rigorous cleaning procedures to ensure data quality. Pearson correlation and linear regression models were used to analyze the relationships between the five variables of interest, including GDP, GDP per capita, fertility decline rate, cumulative case rate, and cumulative death rate. The results of the correlation analysis showed a statistically significant negative correlation (r = -0.440, p-value = 0.007) between the fertility decline rate and cumulative death rate. It suggests that countries with high fertility decline rates during the COVID-19 pandemic tended to have lower cumulative death rates. Moreover, this study inferred that countries with lower fertility decline rates tended to have relatively low mortality rates due to the presence of solid social controls. Stringent social rules and norms, such as restrictions on social gatherings and mobility, were found to reduce the willingness and demand for marriage and childbearing, which may have contributed to lower fertility rates. Overall, this study contributes to understanding the impact of the COVID-19 outbreak on fertility rates and highlights the role of social controls in shaping demographic outcomes during a pandemic. Further research is needed to understand the underlying mechanisms driving these relationships and develop effective policies to address the demographic implications of pandemics.