Background
Increasing antimicrobial resistance among pathogens that cause complicated intraabdominal infections (cIAIs) supports the development of new antimicrobials. Eravacycline, a novel member of the fluorocycline family, is active against multidrug-resistant bacteria including extended-spectrum β-lactamase (ESBL) and carbapenem-resistant Enterobacteriaceae.
Methods
IGNITE4 was a prospective, randomized, double-blind trial. Hospitalized patients with cIAI received either eravacycline 1 mg/kg every 12 hours or meropenem 1 g every 8 hours intravenously for 4–14 days. The primary objective was to demonstrate statistical noninferiority (NI) in clinical cure rates at the test-of-cure visit (25–31 days from start of therapy) in the microbiological intent-to-treat population using a NI margin of 12.5%. Microbiological outcomes and safety were also evaluated.
Results
Eravacycline was noninferior to meropenem in the primary endpoint (177/195 [90.8%] vs 187/205 [91.2%]; difference, –0.5%; 95% confidence interval [CI], –6.3 to 5.3), exceeding the prespecified margin. Secondary endpoints included clinical cure rates in the modified ITT population (231/250 [92.4%] vs 228/249 [91.6%]; difference, 0.8; 95% CI, –4.1, 5.8) and the clinically evaluable population (218/225 [96.9%] vs 222/231 [96.1%]; (difference, 0.8; 95% CI –2.9, 4.5). In patients with ESBL-producing Enterobacteriaceae, clinical cure rates were 87.5% (14/16) and 84.6% (11/13) in the eravacycline and meropenem groups, respectively. Eravacycline had relatively low rates of adverse events for a drug of this class, with less than 5%, 4%, and 3% of patients experiencing nausea, vomiting, and diarrhea, respectively.
Conclusions
Treatment with eravacycline was noninferior to meropenem in adult patients with cIAI, including infections caused by resistant pathogens.
Clinical Trials Registration
NCT01844856.
Cesarean section (CS) is the most common operative procedure performed in sub-Saharan Africa (SSA), accounting for as much as 80% of the surgical workload. In contrast to CSs performed in high-income countries, CSs performed in SSA are accompanied by high morbidity and mortality rates. This operation is the most important known variable associated with an increased probability of postpartum bacterial infection. The objective of this review was to assess surgical outcomes related to CS in SSA. PubMed (including Medline), CINAHL, Embase, and the World Health Organization’s Global Health Library were searched without date or language restrictions. A total of 26 studies reporting surgical site–infection rates after CS were identified, representing 14,063 women from 14 countries. The vast majority (76.7%) of CSs performed were emergency operations. The overall CS rate for women included in this review was 12.4% (range: 1.0%–41.9%). Only 17 of 26 total studies reported a significant proportion of women receiving antimicrobials of any kind. The surgical site–infection rate was 15.6% and the wound-infection rate 10.3%.
Surgical site infections remain an important topic of concern for surgeons in all specialties and are currently the focus of global health agencies for prevention. Because patients have numerous co-morbidities that increase the risks of surgical site infections, and because of the emergence of more resistant pathogens, it is necessary to revise and update guidelines to assist surgeons in the prevention of these infections. This article will summarize the most recent WHO Global Guidelines for the prevention of Surgical Site Infection that will have applicability for surgeons in all countries.
Aim: Recently approved for use in complicated intra-abdominal infection, eravacycline is a novel fluorocycline with broad spectrum of activity against resistant Gram-negative pathogens. This manuscript is a pooled analysis of two Phase III trials. Clinical efficacy: Clinical cure rates were 86.8% for eravacycline versus 87.6% for ertapenem, and 90.8% for eravacycline versus 91.2% for meropenem in the Intent to Treat (micro-ITT) populations, and 87.0% for eravacycline versus 88.8% ertapenem, and 92.4 versus 91.6% for meropenem in the Modified Intent to Treat (MITT) populations. Safety: Eravacycline is well tolerated, with lower rates of nausea, vomiting and diarrhea than other tetracyclines. Conclusion: Eravacycline is an effective new option for use in complicated intra-abdominal infections, and in particular, for the treatment of extended-spectrum β-lactamase- and carbapenem-resistant Enterobacteriaceae-expressing organisms.
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