scholarly journals 1983. Adherence vs. Non-adherence: Clinical Outcomes of an Antimicrobial Stewardship Directed Treatment Protocol for Clostridioides difficile Infection

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S663-S664
Author(s):  
Brendan Begnoche ◽  
Victor Chen ◽  
Nidhi Saraiya ◽  
Yi Guo

Abstract Background The 2018 Infectious Diseases Society of America (IDSA) C. difficile infection (CDI) treatment guideline no longer recommends metronidazole as first-line therapy in adults, instead recommending vancomycin or fidaxomicin. At our 1500-bed academic medical center, a new CDI treatment protocol was initiated by the antimicrobial stewardship program (ASP) to guide treatment based on disease severity and risk factors for recurrence. In this study, we compared the clinical cure rate and 30-day recurrence rate in patients who are adherent and non-adherent to our institutional CDI treatment protocol. Methods Patients with CDI between September-December 2018 were identified using electronic health record (EHR) reports. A retrospective chart review was conducted to collect the following information: baseline demographics, white blood cell count, CDI severity, and risk factors, etc. Outcome measures included clinical cure rate, 30-day recurrence rate, and global cure rate, stratified by whether treatment was adherent or non-adherent to institutional protocol. Student’s t-test was used for continuous variables. Fisher exact test or Chi-square test was used for categorical variables. Results A total of 188 patients (adherent group n = 100; non-adherent group n = 88) were included. Patient demographics and baseline risk factors did not differ between groups. Clinical cure rate was higher in adherent group (P < 0.05), while no significant differences were observed in recurrence and global cure rates between the two groups (Figure 1). The overall protocol adherence rate was 53%. The most common reasons for non-adherence are inappropriate vancomycin dose for fulminant CDI (69%) and insufficient duration of treatment (27%). Conclusion An ASP directed new CDI treatment protocol was successfully implemented at our institution. Patients treated according to our institutional protocol resulted in a higher overall cure rate than those non-adherent. Global cure and 30-day recurrence rates were similar. An overall protocol adherence rate of 53% is consistent with previously published literature. Future direction to develop an EHR order set with targeted recommendations is anticipated to further improve adherence and clinical outcomes. Disclosures All authors: No reported disclosures.

2021 ◽  
Vol 53 (3) ◽  
Author(s):  
Saleh Boudelal ◽  
Mounir Adnane ◽  
Abdelatif Niar

Clinical endometritis (CE) is a serious disease leading to poor reproductive performances in lactating dairy cows, thus diminishing farm profitability. To preserve optimum reproductive efficiency, various strategies and therapeutic approaches have been proposed to manage cows with CE, often with contradictory results. Thus, investigating new paths to CE treatment is economically important. The aim of the present study was to test the efficacy of three therapeutic protocols on the clinical cure rate of CE, and improvement of reproductive performance. Cows with CE (n=42), 21–38 days in milk (DIM), were assigned to three treatment groups: PGF: cows (n=19) were treated systemically with two doses of d-cloprostenol, a PGF2α analogue, at 14-days intervals; CEFAX: cows (n=10) received an intrauterine infusion of the combined antibiotics Cefacetrile and Rifaximin; and NAX: cows (n=13) received systemic treatment with Ceftiofur crystalline free acid (CCFA). A control group included cows (n=36) free from CE (healthy group: HE). All cows were clinically re-examined after the end of the treatment protocol. The clinical cure rate was 73.7%, 80% and 69.2% in PGF, CEFAX, and NAX groups, respectively (P&gt;0.05). The HE group had a significantly shorter calving to first service interval compared to CEFAX and PGF groups (P&lt;0.05), however the difference was not significant with NAX group. The mean calving to fertilizing service interval (CFI) was slightly higher in all three treatment groups compared to the HE group, however the difference was not significant (P&gt;0.05). CEFAX protocol resulted in shorter but not statistically significant CFI, compared to the PGF and NAX protocols. Services per conception rate were slightly lower (1.7) in the CEFAX group compared to HE (1.75), PGF (1.84) and NAX (2.23) groups, however these differences were not significant. First service conception rate and conception rate at 105 DIM did not differ statistically between the treatment groups. While the difference was not significant, CEFAX protocol had slightly better cure rate for CE, reducing the number of services per conception and boosting the resumption of ovarian activity after calving. Validating these finding on a larger herd size will improve the accuracy of these findings.


2021 ◽  
Author(s):  
Yanyan Wu ◽  
Kai Chen ◽  
Fanding He ◽  
Rongjie Quan ◽  
Xuanyan Guo

Abstract Background: Although corticosteroid injection remains a common first-line treatment of trigger finger, but not all cases of trigger finger respond the same. This study aims to compare the clinical effectiveness of ultrasonography-guided corticosteroid injection with and without needle knife release of A1 pulley in treating trigger finger. Methods: 49 patients with trigger fingers (55 fingers, thumb) were included in this study. 28 fingers underwent ultrasonography-guided corticosteroid injection plus needle knife release of A1 pulley (combination group), and 27 fingers underwent only ultrasonography-guided needle knife release of A1 pulley (monotherapy group). Visual analogue scale (VAS), Froimson scale, postoperative recurrence rate, and thickness of A1 pulley in pre-operation and follow-up period were recorded. Results: Higher clinical amelioration and clinical cure rate were observed in combination group at 2 weeks after treatment among patients with Froimson scale Grade III and IV (p<0.05). Among Grade IV patients, combination group had narrower thickness of A1 pulley and better pain relief at 2 weeks postoperatively (all p<0.05). There was no significant difference regarding the values of clinical amelioration rate, clinical cure rate, thickness of the A1 pulley, pain relief and recurrence rate between the two groups at 12 week and 6 months postoperatively (all p>0.05). Conclusion: Ultrasonography-guided corticosteroid injection combined with needle knife release of A1 pulley had superiority in early-stage pain relief and narrowing the thickness of A1 pulley than single needle knife release, but its medium and long-term effects were not obvious.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S829-S830
Author(s):  
Elwyn W Welch ◽  
Shaila Sheth ◽  
Chester Ashong ◽  
Caroline Pham

Abstract Background Nitrofurantoin has been used to treat cystitis in women; however, data supporting its use in men is lacking. In addition, recent retrospective studies have challenged the manufacturer’s recommendation to avoid nitrofurantoin with creatinine clearances (CrCl) less than 60 mL/min. The purpose of this study is to compare the efficacy and safety of nitrofurantoin for the treatment of acute cystitis in male and female veterans with variable degrees of renal dysfunction. Methods A retrospective chart review was conducted in adult patients who received nitrofurantoin for acute cystitis in the outpatient setting between May 1, 2018 and May 1, 2019. The primary outcomes were rates of clinical cure as compared between males and females, and across various renal function groups (CrCl greater than 60 mL/min, 30 to 60 mL/min, and less than 30 mL/min) following treatment with nitrofurantoin. The secondary outcome was adverse event rates. Results A total of 446 patients were included with 278 females and 168 males. Overall clinical cure rate was 86.5% (n=386). Clinical cure rate did not vary between genders (p=0.0851) or CrCl ranges (p=1.0) as shown in the tables. Benign prostatic hyperplasia (BPH) was associated with decreased odds of clinical cure (OR 0.50 [95% CI 0.26-0.97], p=0.0404) in addition to cirrhosis (OR 0.22 [95% CI 0.06-0.91], p=0.0357). Adverse events occurred in 2% of patients and did not vary based on gender or renal function. RATES OF CLINICAL CURE Conclusion There was no statistically significant difference in clinical cure with nitrofurantoin between genders and various renal impairments. However, history of BPH and cirrhosis were associated with decreased efficacy. Subgroup analysis also revealed lower efficacy in males with CrCl greater than 60 mL/min versus females with similar renal function. This study adds to the growing body of literature suggesting that renal dysfunction with CrCl of 30 to 60 mL/min may not carry the risk of treatment failure and adverse effects previously associated with nitrofurantoin, but large randomized trials are needed to confirm these results. Disclosures All Authors: No reported disclosures


2007 ◽  
Vol 51 (10) ◽  
pp. 3612-3616 ◽  
Author(s):  
George H. Talbot ◽  
Dirk Thye ◽  
Anita Das ◽  
Yigong Ge

ABSTRACT Ceftaroline, the bioactive metabolite of ceftaroline fosamil (previously PPI-0903, TAK-599), is a broad-spectrum cephalosporin with potent in vitro activity against multidrug-resistant gram-positive aerobic pathogens, including methicillin-resistant Staphylococcus aureus. A randomized, observer-blinded study to evaluate the safety and efficacy of ceftaroline versus standard therapy in treating complicated skin and skin structure infections (cSSSI) was performed. Adults with cSSSI, including at least one systemic marker of inflammation, were randomized (2:1) to receive intravenous (i.v.) ceftaroline (600 mg every 12 h) or i.v. vancomycin (1 g every 12 h) with or without adjunctive i.v. aztreonam (1 g every 8 h) for 7 to 14 days. The primary outcome measure was the clinical cure rate at a test-of-cure (TOC) visit 8 to 14 days after treatment. Secondary outcomes included the microbiological success rate (eradication or presumed eradication) at TOC and the clinical relapse rate 21 to 28 days following treatment. Of 100 subjects enrolled, 88 were clinically evaluable; the clinical cure rate was 96.7% (59/61) for ceftaroline versus 88.9% (24/27) for standard therapy. Among the microbiologically evaluable subjects (i.e., clinically evaluable and having had at least one susceptible pathogen isolated at baseline), the microbiological success rate was 95.2% (40/42) for ceftaroline versus 85.7% (18/21) for standard therapy. Relapse occurred in one subject in each group (ceftaroline, 1.8%; standard therapy, 4.3%). Ceftaroline exhibited a very favorable safety and tolerability profile, consistent with that of marketed cephalosporins. Most adverse events from ceftaroline were mild and not related to treatment. Ceftaroline holds promise as a new therapy for treatment of cSSSI and other serious polymicrobial infections.


Antibiotics ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. 485 ◽  
Author(s):  
Reem Almutairy ◽  
Waad Aljrarri ◽  
Afnan Noor ◽  
Pansy Elsamadisi ◽  
Nour Shamas ◽  
...  

Colistin therapy is associated with the development of nephrotoxicity. We examined the incidence and risk factors of nephrotoxicity associated with colistin dosing. We included adult hospitalized patients who received intravenous (IV) colistin for >72 h between January 2014 and December 2015. The primary endpoint was the incidence of colistin-associated acute kidney injury (AKI). The secondary analyses were predictors of nephrotoxicity, proportions of patients inappropriately dosed with colistin according to the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Garonzik formula and clinical cure rate. We enrolled 198 patients with a mean age of 55.67 ± 19.35 years, 62% were men, and 60% were infected with multidrug-resistant organisms. AKI occurred in 44.4% (95% CI: 37.4–51.7). Multivariable analysis demonstrated that daily colistin dose per body weight (kg) was associated with AKI (OR: 1.57, 95% CI: 1.08–2.30; p = 0.02). Other significant predictors included serum albumin level, body mass index (BMI), and severity of illness. None of the patients received loading doses, however FDA-recommended dosing was achieved in 70.2% and the clinical cure rate was 13%. The incidence of colistin-associated AKI is high. Daily colistin dose, BMI, serum albumin level, and severity of illness are independent predictors of nephrotoxicity.


2019 ◽  
Vol 8 (6) ◽  
pp. 866 ◽  
Author(s):  
Shao-Huan Lan ◽  
Shen-Peng Chang ◽  
Chih-Cheng Lai ◽  
Li-Chin Lu ◽  
Chien-Ming Chao

This study aims to assess the clinical efficacy and safety of eravacycline for treating complicated intra-abdominal infection (cIAI) in adult patients. The PubMed, Web of Science, EBSCO, Cochrane databases, Ovid Medline, Embase, and ClinicalTrials.gov were searched up to May 2019. Only randomized controlled trials (RCTs) that evaluated eravacycline and other comparators for the treatment of cIAI were included. The primary outcome was the clinical cure rate at the test-of-cure visit based on modified intent-to-treat population, microbiological intent-to-treat population, clinically evaluable population, and microbiological evaluable population, and the secondary outcomes were clinical failure rate and the risk of adverse event. Three RCTs were included. Overall, eravacycline had a clinical cure rate (88.7%, 559/630) at test-of-cure in modified intent-to-treat population similar to comparators (90.1%, 492/546) in the treatment of cIAIs (risk ratio (RR), 0.99; 95% confidence interval (CI), 0.95–1.03; I2 = 0%, Figure 3). In the microbiological intent-to-treat, clinically evaluable, and microbiological evaluable populations, no difference was found between eravacycline and comparators in terms of clinical cure rate at test-of-cure (microbiological intent-to-treat population, RR, 0.99; 95% CI, 0.95–1.04; I2 = 0%, clinically evaluable population, RR, 1.00; 95% CI, 0.97–1.03; I2 = 0%, microbiological evaluable population, RR, 0.98; 95% CI, 0.95–1.02; I2 = 0%). In addition, eravacycline had clinical failure rate similar to comparators at test-of-cure in modified intent-to-treat population (RR, 1.01; 95% CI, 0.61–0.69; I2 = 0%), microbiological intent-to-treat population (RR, 1.34; 95% CI, 0.77–2.31; I2 = 16%), clinically evaluable population (RR, 1.03; 95% CI, 0.61–1.76; I2 = 0%), and microbiological evaluable population (RR, 1.32; 95% CI, 0.75–2.32; I2 = 10%). Although eravacycline was associated with higher risk of treatment-emergent adverse event than comparators (RR, 1.34; 95% CI, 1.13–1.58; I2 = 0%), no significant differences were found between eravacycline and comparators for the risk of serious adverse event (RR, 1.04; 95% CI, 0.65–1.65; I2 = 0%), discontinuation of study drug because of adverse event (RR, 0.68; 95% CI, 0.23–1.99; I2 = 13%), and all-cause mortality (RR, 1.09; 95% CI, 0.41–2.9; I2 = 28%). In conclusion, the clinical efficacy of eravacycline is as high as that of the comparator drugs in the treatment of cIAIs and this antibiotic is as well tolerated as the comparators.


Antibiotics ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 255 ◽  
Author(s):  
Che-Kim Tan ◽  
Chih-Cheng Lai ◽  
Chien-Ming Chao

This study reports an integrated analysis of three randomized controlled trials to compare the clinical efficacies and safety of the ceftazidime–avibactam (CAZ–AVI) combination and meropenem in the treatment of adult patients with complicated intra-abdominal infections (cIAIs). Overall, a total of 1677 patients (CAZ–AVI: 835 patients; meropenem: 842 patients) were included in this analysis. CAZ–AVI had a clinical cure rate at test of cure in the clinically evaluable (CE) population similar to that of meropenem (OR, 0.88; 95% CI, 0.58–1.32; I2 = 0%). Similar trends were also observed in the modified intent-to-treat (MITT) population (OR, 0.80; 95% CI, 0.59–1.09; I2 = 0%) and microbiological evaluable (ME) population (OR, 0.73; 95% CI, 0.32–1.68; I2 = 0%). In terms of clinical cure rate at the end of treatment, the efficacy of CAZ–AVI was comparable to that of meropenem in the CE population (OR, 0.77; 95% CI, 0.47–1.25; I2 = 0%), MITT population (OR, 0.70; 95% CI, 0.47–1.06; I2 = 5%), and ME population (OR, 1.26; 95% CI, 0.39–4.08; I2 = 0%). CAZ–AVI had a similar risk of (i) treatment emergent adverse events (TEAEs) (OR, 1.03; 95% CI, 0.79–1.36; I2 = 38%), (ii) any serious adverse events (OR, 0.97; 95% CI, 0.67–1.40; I2 = 0%), (iii) discontinuation of study drug due to TEAE (OR, 2.14; 95% CI, 1.00–4.57), and iv) all-cause mortality (OR, 1.66; 95% CI, 0.78–3.53; I2 = 0%) when compared with meropenem. In conclusion, CAZ–AVI had comparable efficacy and safety profile to those of meropenem in the treatment of cIAI.


2012 ◽  
Vol 56 (4) ◽  
pp. 2037-2047 ◽  
Author(s):  
Marci L. English ◽  
Christine E. Fredericks ◽  
Nancy A. Milanesio ◽  
Nestor Rohowsky ◽  
Ze-Qi Xu ◽  
...  

ABSTRACTCommunity-acquired pneumonia (CAP) continues to be a major health challenge in the United States and globally. Factors such as overprescribing of antibiotics and noncompliance with dosing regimens have added to the growing antibacterial resistance problem. In addition, several agents available for the treatment of CAP have been associated with serious side effects. Cethromycin is a new ketolide antibiotic that may provide prescribing physicians with an additional agent to supplement a continually limited armamentarium. Two global phase III noninferiority studies (CL05-001 and CL06-001) to evaluate cethromycin safety and efficacy were designed and conducted in patients with mild to moderate CAP. Study CL05-001 demonstrated an 83.1% clinical cure rate in the cethromycin group compared with 81.1% in the clarithromycin group (95% confidence interval [CI], −4.8%, +8.9%) in the intent to treat (ITT) population and a 94.0% cethromycin clinical cure rate compared with a 93.8% clarithromycin cure rate (95% CI, −4.5%, +5.1%) in the per protocol clinical (PPc) population. Study CL06-001 achieved an 82.9% cethromycin clinical cure rate in the ITT population compared with an 88.5% clarithromycin cure rate (95% CI, −11.9%, +0.6%), whereas the clinical cure rate in the PPc population was 91.5% in cethromycin group compared with 95.9% in clarithromycin group (95% CI, −9.1%, +0.3%). Both studies met the primary endpoints for clinical cure rate based on predefined, sliding-scale noninferiority design. Therefore, in comparison with clarithromycin, these two noninferiority studies demonstrated the efficacy and safety of cethromycin, with encouraging findings of efficacy in subjects withStreptococcus pneumoniaebacteremia. No clinically significant adverse events were observed during the studies. Cethromycin may be a potential oral therapy for the outpatient treatment of CAP.


2012 ◽  
Vol 57 (1) ◽  
pp. 647-650 ◽  
Author(s):  
George H. Talbot ◽  
Tanya O'Neal ◽  
Anita F. Das ◽  
Dirk Thye

ABSTRACTWilson et al. (Am. J. Surg.185:369–375, 2003) developed a disease severity classification system for use in complicated skin and skin structure infections (cSSSI). Two phase 3 trials of ceftaroline fosamil in cSSSI provided the opportunity to evaluate the association between Wilson Severity Risk Class and clinical cure rates. Our analyses did not confirm that an association exists between Wilson Severity Risk Class and clinical cure rate and, thus, did not validate its predictive utility.


Author(s):  
Fusheng Bai ◽  
Xinming Li

Background: We aimed to review relevant randomized controlled trials to assess the relative clinical effects of antibiotic treatment of patients with community-acquired pneumonia (CAP). Methods: In this meta-analysis, we identified relevant studies from PubMed, Cochrane, and Embase using appropriate keywords. Key pertinent sources in the literature were also reviewed and all articles published through Oct 2019 were considered for inclusion. For each study, we assessed the risk ratios (RRs) or mean difference combined with the 95% confidence interval (CI) to assess and synthesize outcomes. Results: Overall, 36 studies were consistent with the meta-analysis, involving 17,076 patients. There was no significant difference in the mortality after subgroup analysis: individualized treatment vs. standard treatment; β-lactams plus macrolides vs. β-lactam and/or fluoroquinolone; ceftaroline fosamil vs. ceftriaxone; combination therapy vs. monotherapy or high-dose vs. low-dose. The drug-related adverse event incidence was significantly higher in the ceftriaxone group than in the other drug groups (P<0.05) and also higher in the tigecyline group than in the levofloxacin group (P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the test-of-cure (TOC) visit in the clinically evaluable population, modified intent-to-treat efficacy (MITTE) population, microbiologically evaluable (ME) population and the microbiological MITTE (mMITTE) population (all P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the TOC visit in the mMITTE population of Gram positiveStreptococcus pneumoniae (P<0.05) and multidrug-resistant S. pneumoniae (P<0.05). Conclusion: There was a limited number of included studies in the subgroup analysis, but it will still be necessary to conduct more high-quality randomized controlled trials to confirm the clinical efficacy of different antibiotics used to treat CAP.


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