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This is a protocol for PPROM-AZM Study, phase II, nonblinded, randomized controlled trial. Bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks (BPD 36 ) is often observed in infants with preterm premature rupture of the membranes (pPROM). A regimen of ampicillin (ABPC) intravenous infusion for 2 days and subsequent amoxicillin (AMPC) oral administration for 5 days plus erythromycin (EM) intravenous infusion for 2 days followed by EM oral administration for 5 days is standard treatment for pPROM. However, the effect on the prevention of moderate/severe BPD 36 using the standard treatment has not been confirmed. Recently, it is reported that ampicillin/sulbactam (ABPC/SBT) plus azithromycin (AZM) was effective for the prevention of moderate/severe BPD 36 in pPROM patients with amniotic infection of Ureaplasma species. Therefore, our aim is to evaluate the occurrence rate of the composite outcome of “incidence rate of either moderate/severe BPD 36 or intrauterine fetal death, and infantile death at or less than 36 weeks 0 days” comparing subjects to receive ABPC/SBT for 14 days plus AZM for 14 days (intervention group) and those to receive ABPC/SBT for 14 days plus EM for 14 days (control group), in a total of 100 subjects (women with pPROM occurring at 22–27 weeks of gestation) in Japan. The recruit of subjects was started on April 2022, and collection in on-going. We also investigate the association between the detection of Ureaplasma species and occurrence of BPD 36 . In addition, information on any adverse events for the mother and fetus and serious adverse events for infants are collected during the observation period. We allocate patients at a rate of 1:1 considering two stratification factors: onset of pPROM (22–23 or 24–27 weeks) and presence/absence of a hospital policy for early neonatal administration of caffeine. Trial registration: The trial number in the Japan Registry of Clinical Trials is jRCTs031210631 .

PurposeBeta lactams are standard empirical therapy for febrile neutropenia (FN). The aim of this study was to evaluate the efficacy and safety of cefepime monotherapy compared with cefoperazone/sulbactam plus amikacin (CS + A) for empirical treatment of high risk FN.MethodsOne hundred seventy-five patients with 336 FN episodes were randomized to receive either cefepime (2 g q8h for adults and 50 mg/kg q8h for children) or CS (2 g q8h for adults and 50 mg/kg q8h for children) plus amikacin (15 mg/kg once a day). Positive response was defined as afebrile within 72 h of starting antibiotics, persistent afebrile status more than 48 h and no requirement of second-line antibiotics and antifungal agents.ResultsThree hundred thirty-six episodes were assessable for efficacy (168 cefepime, 168 CS + A). The positive response to antibiotics was identical for cefepime (53%) and CS + A (53%). Positive response was similar in MDI (microbiologically documented infection), 50 vs. 35% (p = 0.248), CDI (clinically documented infection), 50 vs. 35% (p = 0.259), combination CDI + MDI, 25 vs. 15% (p = 0.400), FUO (fever of unknown origin), 68 vs. 72% (p = 0.577) respectively in the two groups. The successful discontinuation of antibiotics at 72 h in FUO was similar in both groups (60 vs. 59%, p = 0.544). Total drug-related adverse events were similar in both groups (8 vs. 6%) except renal dysfunction was high in CS + A (1 vs. 7 events). Mortality was the same between two groups (8 vs 7%).ConclusionsCefepime monotherapy and CS + A had similar efficacy as first-line therapy for FN. Discontinuation of empirical antibiotics is safe and feasible approach in selected group of FUO patients.

[...]it has homogenous restricted diffusion (arrows) on the diffusion-weighted image (DWI) (D) with its respective attenuation diffusion coefficient (ADC) (E). [...]sagittal (A) and axial (F) T2-weighted images show associated surrounding inflammatory findings, such as a probably inflammatory nodule in the vesicouterine pouch, 1.5 × 1.5 cm, indicated with a star in (A), and thickening of both fallopian tubes, indicated with arrows in (F). [...]the conjunction of well-defined borders of the mass and the surrounding inflammatory findings possibly represented a pelvic inflammatory process involving the cervix. [...]the two possible diagnoses in such a scenario are cervical malignancy and cervicitis. Based on the history of bacterial infection, the elevated white blood cell count, fever, and abdominal pain, we considered that the patient most likely had a diagnosis of pelvic inflammatory disease and recommendation for immediate laparoscopy was suggested. To our knowledge, there were no published data on anaerobic Gram-positive bacteria (actinomyces) in the cervix, mimicking a International Federation of Gynecology and Obstetrics (FIGO) stage I cervical cancer.

Background Intra-abdominal infections are one of the most common infections encountered by a general surgeon. However, despite this prevalence, standardized guidelines outlining the proper use of antibiotic therapy are poorly defined due to a lack of clinical trials investigating the ideal duration of antibiotic treatment. The aim of this study is to compare the efficacy and safety of a three-day treatment regimen of Ampicillin-Sulbactam to that of a three-day regimen of Ertapenem in patients with localized peritonitis ranging from mild to moderate severity. Methods This study is a prospective, multi-center, randomized investigation performed in the Department of General, Emergency, and Transplant Surgery of St. Orsola-Malpighi University Hospital in Bologna, Italy. Discrete data were analyzed using the Chi-squared and Fisher exact tests. Differences between the two study groups were considered statistically significant for p-values less than 0.05. Results 71 patients were treated with Ertapenem and 71 patients were treated with Ampicillin-Sulbactam. The two groups were comparable in terms of age and gender as well as the site of abdominal infection. Post-operative infection was identified in 12 patients: 10 with wound infections and 2 with intra-abdominal infections. In the Ertapenem group, 69 of the 71 patients (97%) were treated successfully, while the therapy failed in 2 cases (3%). Therapy failures were more frequent in the Unasyn group, amounting to 10 of 71 cases (p = 0.03). Conclusion According to these preliminary findings, the authors conclude that a three-day Ertapenem treatment regimen is the most effective antibiotic therapy for patients with localized intra-abdominal infections ranging from mild to moderate severity. Trial registration Trial registration: ClinicalTrials.gov: NCT00630513

The number and diversity of β-lactamases are steadily increasing. The emergence of β-lactamases that hydrolyze carbapenems poses a significant threat to our antibiotic armamentarium. The explosion of OXA enzymes that are carbapenem hydrolyzers is a major challenge (carbapenem-hydrolyzing class D [CHD]). An urgent need exists to discover β-lactamase inhibitors with class D activity. The sulbactam-ETX2514 combination demonstrates the potential to become a treatment regimen of choice for Acinetobacter spp. producing class D β-lactamases. Multidrug-resistant (MDR) Acinetobacter spp. poses a significant therapeutic challenge in part due to the presence of chromosomally encoded β-lactamases, including class C Acinetobacter -derived cephalosporinases (ADC) and class D oxacillinases (OXA), as well as plasmid-mediated class A β-lactamases. Importantly, OXA-like β-lactamases represent a gap in the spectrum of inhibition by recently approved β-lactamase inhibitors such as avibactam and vaborbactam. ETX2514 is a novel, rationally designed, diazabicyclooctenone inhibitor that effectively targets class A, C, and D β-lactamases. We show that addition of ETX2514 significantly increased the susceptibility of clinical Acinetobacter baumannii isolates to sulbactam. AdeB and AdeJ were identified to be key efflux constituents for ETX2514 in A. baumannii . The combination of sulbactam and ETX2514 was efficacious against A. baumannii carrying bla TEM-1 , bla ADC-82 , bla OXA-23 , and bla OXA-66 in a neutropenic murine thigh infection model. We also show that, in vitro , ETX2514 inhibited ADC-7 ( k 2 / K i 1.0 ± 0.1 × 10 6 M −1 s −1 ) and OXA-58 ( k 2 / K i 2.5 ± 0.3 × 10 5 M −1 s −1 ). Cocrystallization of ETX2514 with OXA-24/40 revealed hydrogen bonding interactions between ETX2514 and residues R261, S219, and S128 of OXA-24/40 in addition to a chloride ion occupied in the active site. Further, the C3 methyl group of ETX2514 shifts the position of M223. In conclusion, the sulbactam-ETX2514 combination possesses a broadened inhibitory range to include class D β-lactamases as well as class A and C β-lactamases and is a promising therapeutic candidate for infections caused by MDR Acinetobacter spp. IMPORTANCE The number and diversity of β-lactamases are steadily increasing. The emergence of β-lactamases that hydrolyze carbapenems poses a significant threat to our antibiotic armamentarium. The explosion of OXA enzymes that are carbapenem hydrolyzers is a major challenge (carbapenem-hydrolyzing class D [CHD]). An urgent need exists to discover β-lactamase inhibitors with class D activity. The sulbactam-ETX2514 combination demonstrates the potential to become a treatment regimen of choice for Acinetobacter spp. producing class D β-lactamases.

Ampicillin/sulbactam (ABPC/SBT) and piperacillin/tazobactam (PIPC/TAZ) are important beta-lactam/beta-lactamase inhibitor combinations. Recently, PIPC/TAZ has been reported to decrease serum potassium level (SPL). To test the hypothesis that ABPC/SBT also has the same impact, we evaluated the change in SPL by ABPC/SBT administration and compared with that by PIPC/TAZ. A retrospective, observational propensity-score matched cohort study was performed using data between 2020 and 2022. After subject selection, multiple regression analysis was conducted to identify risk factors associated with decrease in SPL. Baseline SPL, duration of ABPC/SBT or PIPC/TAZ administration, and female sex were identified as significant risk factors. Using the factors that potentially influence SPL, propensity score matching was performed, and the decrease in SPL was compared between the propensity score-matched cohorts (ABPC/SBT: n = 59, PIPC/TAZ: n = 59). The change in SPL was not significantly different between the two cohorts (− 0.28 ± 0.47 mEq/L vs. − 0.35 ± 0.51 mEq/L, P  = 0.443). In addition, the percent decrease in SPL (10.7 ± 7.0% vs. 11.0 ± 9.7%, P  = 0.822) and the incidence of hypokalemia (25.4% vs. 27.1%, P  = 1.000) were not significantly different. ABPC/SBT decreases SPL comparable to PIPC/TAZ, with a clinically significant effect. Careful monitoring of SPL is necessary when patients with identified risk factors are treated with ABPC/SBT or PIPC/TAZ.

Optimal perioperative antibiotic prophylaxis in kidney transplantation remains undefined despite routine antibiotic administration to prevent infections. In this retrospective observational cohort study with historical comparison, we compared the clinical efficacy of 6 days of ampicillin/sulbactam vs. a single dose of cefazolin. We retrospectively analyzed 2322 kidney transplantation recipients at a single center, with the evaluation period spanning from 2015 through 2021. Patients were divided into 2 groups based on the perioperative antibiotic regimen received: 971 patients received ampicillin/sulbactam, and 1351 received cefazolin. This study focused on evaluating the impact of these regimens on postoperative infection incidence and the 6-month acute rejection (AR) rates. The cefazolin group exhibited a tendency toward higher urinary tract infection rates within 1 month after transplantation (3.4% vs. 2.2%, p= = 0.078). There were no significant differences in surgical site infections between the groups. The 6-month AR rates were significantly lower in the cefazolin group than in the ampicillin/sulbactam group (5.1% vs. 7.9%, p= = 0.009). Cefazolin was also confirmed to be significantly associated with reduced 6-month AR rates in the multivariable logistic regression analysis (odds ratio 0.63, 95% confidence interval [0.45-0.89], p= = 0.009). In this study, we observed that a single dose of cefazolin as perioperative antibiotic prophylaxis may lead to higher rates of postoperative urinary tract infections, but it could potentially lower the incidence of acute rejection within six months.

This case report described a suspected severe coagulopathy attributed to cefoperazone/sulbactam, and this adverse reaction might be associated with the inhibition of the vitamin K cycle by cefoperazone/sulbactam, leading to vitamin K deficiency within the body. We reported a patient diagnosed with bacterial pneumonia, who received cefoperazone/sulbactam during hospitalization. The patient was administered cefoperazone/sulbactam via intravenous infusion at a dose of 1.5 g every 8 h for a consecutive treatment period of 23 days. On the 26th day, the patient developed a serious adverse reaction characterized by prolonged clotting time. After treatment with vitamin K1, the coagulation parameters significantly improved by the 28th day (prothrombin time decreased by 88.4%, activated partial thromboplastin time decreased by 61.1%, and international normalized ratio decreased by 88.5%). The Naranjo assessment score was 5, suggesting that the patient’s coagulation disorder could be related to the use of cefoperazone/sulbactam. This report highlights that patients at high risk of bleeding should be vigilant about the coagulopathy caused by cefoperazone/sulbactam- and extend the duration of coagulopathy monitoring.

Background The objective of this network meta-analysis was to evaluate and compare the efficacy and safety of different antimicrobial regimens used in the treatment of pneumonia caused by extensively drug-resistant (XDR) or multidrug-resistant (MDR) Acinetobacter baumannii (AB). Given the increasing prevalence of resistant strains, identifying optimal treatment strategies is crucial. Materials and methods We systematically analyzed data from randomized controlled trials and retrospective cohort studies retrieved from major electronic databases. The included studies evaluated all-cause mortality, clinical success, microbiological eradication, and nephrotoxicity associated with cefiderocol, intravenous (IV) colistin, inhaled colistin, igecycline, sulbactam, and their combination-based regimens in patients with MDR/XDR-AB pneumonia. Results A total of 19 eligible studies involving 1,941 participants were included in the analysis. Cefiderocol-containing regimens demonstrated the greatest reduction in all-cause mortality (odds ratio (OR): 0.24; 95% CI: 0.09–0.68) compared to other therapies. In terms of clinical success, cefiderocol-containing regimens (OR: 2.77; 95% CI: 1.07–7.19) and inhaled colistin (OR: 2.61; 95% CI: 1.14–5.99) were significantly more effective than other regimens. Microbiological eradication was most notable with inhaled colistin, and with IV colistin combined with sulbactam or tigecycline. However, nephrotoxicity was commonly observed with IV colistin, while tigecycline monotherapy showed the lowest nephrotoxicity risk (OR: 0.15; 95% CI: 0.04–0.60). Conclusion This study provides comprehensive evidence on current and emerging treatments for MDR/XDR-AB pneumonia. Cefiderocol-containing regimens appears to be the most effective regimen in reducing mortality and improving clinical outcomes, though nephrotoxicity risks must be carefully considered when using IV colistin-based therapies. Clinical trial Not applicable.

BackgroundCefoperazone/sulbactam is commonly prescribed for the treatment of infected patients with cirrhosis.AimTo investigate the effect of cefoperazone/sulbactam on coagulation in cirrhotic patients and assess the effectiveness of vitamin K1 supplementation in preventing cefoperazone/sulbactam-induced coagulation disorders.MethodThis retrospective cohort study compared coagulation function in 217 cirrhotic patients who received cefoperazone/sulbactam with and without vitamin K1 supplementation (vitamin K1 group, n = 108; non-vitamin K1 group, n = 109). Propensity score matching (PSM) was used to to reduce confounders’ influence, the SHapley additive exPlanations (SHAP) model to explore the importance of each variable in coagulation disorders.ResultsIn the non-vitamin K1 group, the post-treatment prothrombin time (PT) was 16.5 ± 6.5 s and the activated partial thromboplastin time (aPTT) was 34.8 ± 9.4 s. These were significantly higher than pre-treatment values (PT: 14.6 ± 2.4 s, p = 0.005; aPTT: 30.4 ± 5.9 s, p < 0.001). In the vitamin K1 group, no differences were observed in PT, thrombin time, or platelet count, except for a slightly elevated post-treatment aPTT (37.0 ± 10.4 s) compared to that of pre-treatment (34.4 ± 7.2 s, p = 0.033). The vitamin K1 group exhibited a lower risk of PT prolongation (OR: 0.211, 95% CI: 0.047–0.678) and coagulation disorders (OR: 0.257, 95% CI: 0.126–0.499) compared to that of the non-vitamin K1 group. Propensity score matching analysis confirmed a reduced risk in the vitamin K1 group for prolonged PT (OR: 0.128, 95% CI: 0.007–0.754) and coagulation disorders (OR: 0.222, 95% CI: 0.076–0.575). Additionally, the vitamin K1 group exhibited lower incidences of PT prolongation, aPTT prolongation, bleeding, and coagulation dysfunction compared to the non-vitamin K1 group.ConclusionCefoperazone/sulbactam use may be linked to a higher risk of PT prolongation and coagulation disorders in cirrhotic patients. Prophylactic use of vitamin K1 can effectively reduce the risk.