scholarly journals Optimizing preoperative antibiotics in patients with β-lactam allergies: A role for pharmacy

2021 ◽  
Author(s):  
Shaina Kwiatkowski ◽  
Surafel Mulugeta ◽  
Susan Davis ◽  
Rachel Kenney ◽  
James Kalus ◽  
...  
Keyword(s):  
Kidney Injury ◽  
Surgical Site Infections ◽  
Standard Of Care ◽  
Pharmacist Intervention ◽  
Decision Algorithm ◽  
Allergy Testing ◽  
Telephone Interviews ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Preoperative Antibiotics

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Patients with a reported β-lactam allergy (BLA) are often given alternative perioperative antibiotic prophylaxis, increasing risk of surgical site infections (SSIs), acute kidney injury (AKI), and Clostridioides difficile infection (CDI). The purpose of this study was to implement and evaluate a pharmacist-led BLA clarification interview service in the preoperative setting. Methods A pharmacist performed BLA clarification telephone interviews before elective procedures from November 2018 to March 2019. On the basis of allergy history and a decision algorithm, first-line preoperative antibiotics, alternative antibiotics, or allergy testing referral was recommended. The pharmacist intervention (PI) group was compared to a standard of care (SOC) group who underwent surgery from November 2017 to March 2018. Results Eighty-seven patients were included, with 50 (57%) and 37 (43%) in the SOC and PI groups, respectively. The most common surgeries included orthopedic surgery in 41 patients (47%) and neurosurgery in 17 patients (20%). In the PI group, all BLA labels were updated after interview. Twenty-three patients were referred for allergy testing, 12 of the 23 (52%) completed BLA testing, and penicillin allergies were removed for 9 of the 12 patients. Overall, 28 of the 37 (76%) pharmacy antibiotic recommendations were accepted. Cefazolin use significantly increased from 28% to 65% after the intervention (P = 0.001). SSI occurred in 5 (10%) patients in the SOC group and no patients in the PI group (P = 0.051). All of these SSIs were associated with alternative antibiotics. Incidence of AKI and CDI was similar between the groups. No allergic reactions occurred in either group. Conclusion Implementation of a pharmacy-driven BLA reconciliation significantly increased β-lactam preoperative use without negative safety outcomes.

scholarly journals 1989. Impact of Pharmacist-Led β-Lactam Allergy Clarification Interview on Optimizing Preoperative Antibiotic Prophylaxis

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S667-S667
Author(s):  
Shaina Kwiatkowski ◽  
Surafel Mulugeta ◽  
Susan L Davis ◽  
Rachel Kenney ◽  
James Kalus ◽  
...  
Keyword(s):  
Antibiotic Prophylaxis ◽  
Kidney Injury ◽  
Surgical Site Infections ◽  
Allergic Reactions ◽  
Post Intervention ◽  
Decision Algorithm ◽  
Allergy Testing ◽  
Clostridioides Difficile ◽  
Quasi Experimental ◽  
Preoperative Antibiotic Prophylaxis

Abstract Background Patients with reported β-lactam allergies (BLA) are often given alternative perioperative antibiotic prophylaxis, increasing risk of surgical site infections (SSI), acute kidney injury (AKI), and Clostridioides difficile infection (CDI). The purpose of this study was to implement and evaluate a pharmacist-led BLA clarification interview in the preoperative setting. Methods This single-center, IRB-approved, quasi-experimental study compared surgical patients with a BLA between November 2017 and March 2018 (pre-intervention) vs. November 2018 and March2019. From November 2018 to March 2019, a pharmacist performed BLA clarification phone interviews for patients scheduled for a surgical procedure. Based on the allergy history and decision algorithm, first-line antibiotics, alternative antibiotics, or an allergy testing referral were recommended and documented in the EHR. The allergy label was updated as well. The primary outcome was the use of β-lactams preoperatively. Secondary outcomes included 30-day SSI and CDI, AKI, allergic reactions, allergy labels updated or removed, time to incision, and vancomycin doses administered. Results 87 patients were included in the study; 50 (57%) and 37 (43%) in the pre- and post-group, respectively. Most common surgeries: orthopedic 41 (47%), neurosurgery 17 (20%). In the post-group, all EHR BLA labels were updated after interview. 23 patients were referred for allergy testing, 12 (52%) completed BLA testing, and 7 BLA allergies were removed. 76% of pharmacy antibiotic recommendations were accepted (figure). Cefazolin use significantly increased from 28% to 65% post-intervention, P = 0.001; vancomycin use also increased from 19 (38%) to 22 (59%), P = 0.047. Time to incision decreased by a median of 8 minutes (P = 0.484). SSI occurred in 5 (10%) patients in the pre-group only, P = 0.051. All of these were associated with alternative antibiotics. Incidence of AKI and CDI were similar between the groups (P > 0.05). No allergic reactions occurred in either group. Conclusion Clarifying reported BLA in the perioperative setting significantly increased β-lactam preoperative use without negative clinical sequelae. Disclosures All authors: No reported disclosures.

scholarly journals The “Torment” of Surgical Antibiotic Prophylaxis among Surgeons

Antibiotics ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1357
Author(s):  
Massimo Sartelli ◽  
Federico Coccolini ◽  
Angeloantonio Carrieri ◽  
Francesco M. Labricciosa ◽  
Enrico Cicuttin ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Side Effects ◽  
Antibiotic Prophylaxis ◽  
Kidney Injury ◽  
Surgical Site Infections ◽  
Surgical Interventions ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Surgical Antibiotic Prophylaxis ◽  
Operative Measures

Surgical antibiotic prophylaxis (SAP) is one of the peri-operative measures for preventing surgical site infections (SSIs). Its goal is to counteract the proliferation of bacteria in the surgical site during intervention in order to reduce the risk of SSIs. SAP should be administered for surgical interventions where the benefit expected (prevention of SSIs) is higher compared to the risk (serious side effects, such as acute kidney injury, Clostridioides difficile infection, and the spread of antimicrobial resistance). In prescribing SAP, surgeons should have both the awareness necessary “to handle antibiotics with care”, and the knowledge required to use them appropriately.

scholarly journals The Importance of Abnormal Platelet Count in Patients with Clostridioides difficile Infection

2021 ◽  
Vol 10 (13) ◽  
pp. 2957
Author(s):  
Shira Buchrits ◽  
Anat Gafter-Gvili ◽  
Jihad Bishara ◽  
Alaa Atamna ◽  
Gida Ayada ◽  
...  
Keyword(s):  
Platelet Count ◽  
Medical Center ◽  
Multivariable Analysis ◽  
Kidney Injury ◽  
Innate And Adaptive Immunity ◽  
Clostridioides Difficile ◽  
All Cause Mortality ◽  
Clostridioides Difficile Infection ◽  
Multivariable Analyses ◽  
Wbc Count

Background: Clostridium difficile infection (CDI) causes morbidity and mortality. Platelets have been increasingly recognized as an important component of innate and adaptive immunity. We aimed to assess the incidence of thrombocytopenia and thrombocytosis in CDI and the effect of an abnormal platelet count on clinical outcomes. Methods: This single-center, retrospective cohort study consisted of all adult patients hospitalized in Rabin Medical Center between 1 January 2013 and 31 December 2018 with laboratory confirmed CDI. The primary outcome was 30-day all-cause mortality. Risk factors for 30-day all-cause mortality were identified by univariable and multivariable analyses, using logistic regression. Results: A total of 527 patients with CDI were included. Among them 179 (34%) had an abnormal platelet count: 118 (22%) had thrombocytopenia and 61 (11.5%) had thrombocytosis. Patients with thrombocytosis were similar to control patients other than having a significantly higher white blood cell count at admission. Patients with thrombocytopenia were younger than control patients and were more likely to suffer from malignancies, immunosuppression, and hematological conditions. In a multivariable analysis, both thrombocytosis (OR 1.89, 95% CI 1.01–3.52) and thrombocytopenia (OR 1.70, 95% CI 1.01–2.89) were associated with 30-days mortality, as well as age, hypoalbuminemia, acute kidney injury, and dependency on activities of daily living. A sensitivity analysis restricted for patients without hematological malignancy or receiving chemotherapy revealed increased mortality with thrombocytosis but not with thrombocytopenia. Conclusions: In this retrospective study of hospitalized patients with CDI, we observed an association between thrombocytosis on admission and all-cause mortality, which might represent a marker for disease severity. Patients with CDI and thrombocytopenia also exhibited increased mortality, which might reflect their background conditions and not the severity of the CDI. Future studies should assess thrombocytosis as a severity marker with or without the inclusion of the WBC count.

Retrospective Analysis of Adverse Drug Events Between Nafcillin Versus Cefazolin for Treatment of Methicillin-Susceptible Staphylococcus aureus Infections

2019 ◽  
Vol 54 (7) ◽  
pp. 662-668 ◽  
Author(s):  
Lynn Chan ◽  
Noreen H. Chan-Tompkins ◽  
James Como ◽  
Anthony J. Guarascio
Keyword(s):  
Staphylococcus Aureus ◽  
Adverse Drug Events ◽  
Independent Predictor ◽  
Kidney Injury ◽  
Inpatient Setting ◽  
Risk Class ◽  
Clostridioides Difficile ◽  
Risk Stratum ◽  
Clostridioides Difficile Infection ◽  
Elevated Transaminases

Background: Nafcillin or cefazolin are drugs of choice for methicillin-susceptible Staphylococcus aureus (MSSA) infections. Prior studies indicate a higher incidence of acute kidney injury (AKI) with nafcillin, although AKI classification and time to occurrence is not well described. Objective: To characterize the incidence and time to adverse drug events for nafcillin versus cefazolin in the inpatient setting. Methods: A retrospective cohort study evaluated hospitalized, adult patients receiving intravenous nafcillin or cefazolin for treatment of MSSA infection. Incidence and time to AKI based on RIFLE criteria were measured. Secondary end points included antibiotic discontinuation and incidence of neutropenia, thrombocytopenia, elevated transaminases, and Clostridioides difficile infection (CDI). Results: Of 324 patients who received nafcillin (n = 119) or cefazolin (n = 205), higher rates of AKI were found for nafcillin versus cefazolin (19% vs 2%, respectively; P < 0.0001). Median time to AKI with nafcillin was 6.5 days (range, 3-14 days). The majority of patients were classified as RIFLE “Risk” stratum. Nafcillin treatment discontinuations were more frequent than for cefazolin (17.6% vs 0.9%, respectively; P < 0.0001). Nafcillin was an independent predictor of AKI (odds ratio = 12.4; 95% CI = 4.14-47.60, P < 0.0001). No differences in neutropenia, thrombocytopenia, elevated transaminases, or CDI were observed. Conclusion and Relevance: Nafcillin displayed higher rates of AKI at a median of 1 week of therapy, which provides a framework for clinician monitoring and consideration of antibiotic modification. Most patients developed “Risk” class AKI (RIFLE classification), which may be reversible with prompt intervention.

scholarly journals 1042. Safety of Investigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioides difficile Infection: Data from Five Prospective Clinical Studies

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S611-S611
Author(s):  
Tricia Braun ◽  
Beth Guthmueller ◽  
Adam J Harvey
Keyword(s):  
Clinical Studies ◽  
Ad Hoc ◽  
Safety Data ◽  
Standard Of Care ◽  
Oral Antibiotic ◽  
Open Label ◽  
Two Phase ◽  
Oral Antibiotic Therapy ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

Abstract Background Microbiota-based treatments have shown promise to reduce recurrence, morbidity, and mortality for recurrent Clostridioides difficile infections (rCDI), but consistent and reliable safety data are needed to support regulatory approvals and broaden patient access. Here we provide cumulative safety data from 5 prospective clinical studies evaluating RBX2660—a standardized, microbiota-based investigational live biotherapeutic—for reducing rCDI. Methods This analysis included three Phase 2 (PUNCH CD, PUNCH CD2, PUNCH CD Open Label) and two Phase 3 trials (PUNCH CD3, PUNCH CD3-OLS ad hoc analysis). Participants were ≥18 years old with documented rCDI who completed standard-of-care oral antibiotic therapy prior to treatment with RBX2660. PUNCH CD3-OLS allowed participants with comorbidities of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD). Depending on the trial, assigned study treatment was 1 or 2 doses of RBX2660 (or placebo), administered rectally. Participants whose CDI recurred within 8 weeks were eligible for additional RBX2660 treatment. Treatment-emergent adverse events (TEAEs) were recorded for at least 6 months following last study treatment; CD2 and CD Open Label recorded TEAEs for 24 months. Results Among 620 participants who received at least one RBX2660 dose (assigned treatment or after recurrence), 324 (52.3%) received 1, 270 (43.5%) received 2, 14 (2.3%) received 3, and 12 (1.9%) received 4. 83 participants received blinded placebo only. A total of 1980 TEAEs were reported from 432 (69.7%) RBX2660-treated participants, compared to 174 TEAEs in 50 (60.2%) placebo-only treated participants. Most TEAEs were mild or moderate in severity, with diarrhea common in all treatment groups. No potentially life-threatening TEAEs were considered related to RBX2660. Study discontinuation due to TEAEs was minimal (&lt; 1%) with none related to RBX2660. There were no reported infections for which the causative pathogen was traced to RBX2660. Conclusion Across five clinical studies with consistent investigational product, RBX2660 was well-tolerated in rCDI participants. In aggregate, this data provides compelling and consistent safety data for RBX2660. Disclosures Tricia Braun, PharmD, Rebiotix, a Ferring Company (Employee) Beth Guthmueller, AS, Rebiotix Inc, A Ferring Company (Employee) Adam J. Harvey, PhD, Rebiotix, A Ferring Company (Employee)

scholarly journals Real-world Experience of Bezlotoxumab for Prevention of Clostridioides difficile Infection: A Retrospective Multicenter Cohort Study

2020 ◽  
Vol 7 (4) ◽  
Author(s):  
Richard L Hengel ◽  
Timothy E Ritter ◽  
Ramesh V Nathan ◽  
Lucinda J Van Anglen ◽  
Claudia P Schroeder ◽  
...  
Keyword(s):  
Real World ◽  
Standard Of Care ◽  
The United States ◽  
Study Cohort ◽  
Multicenter Cohort Study ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Comorbidity Index ◽  
Clinical Trial Results ◽  
Successful Prevention

Abstract Background Bezlotoxumab is approved for prevention of recurrence of Clostridioides difficile infection (CDI) in adults receiving standard of care (SoC) therapy based on findings from MODIFY clinical trials. However, utilization practices and validation of trial results in the real world are limited. Methods Records of patients receiving bezlotoxumab between April 2017 and December 2018 across 34 infusion centers in the United States were retrospectively reviewed. Recurrent CDI (rCDI), defined as diarrhea lasting ≥2 days resulting in treatment, was assessed 90 days postbezlotoxumab. Results The study cohort included 200 patients (median age, 70 years; 66% female; median Charlson comorbidity index, 5), of whom 86% (n = 173) had prior CDI episodes and 79% (n = 158) had ≥2 risk factors for rCDI. SoC antibiotics included vancomycin (n = 137, 68%), fidaxomicin (n = 60, 30%), and metronidazole (n = 3, 2%). Median time from C. difficile stool test to bezlotoxumab and initiation of SoC to bezlotoxumab were 15 days and 11 days, respectively. Within 90 days, 31 of 195 patients (15.9%) experienced rCDI, which corresponds to a success rate of 84.1%. Patients with ≥2 CDI recurrences prebezlotoxumab had a higher risk of subsequent rCDI compared with those with 1 recurrence or primary CDI (hazard ratio, 2.77; 95% confidence interval, 1.14–6.76; P = .025). Conclusions This real-world multicenter study demonstrated successful prevention of rCDI with bezlotoxumab comparable to clinical trial results regardless of type of SoC and timing of infusion. Multiple prior CDI recurrences were associated with a higher risk of subsequent rCDI, supporting the use of bezlotoxumab earlier in the disease course.

scholarly journals SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial

2020 ◽  
Author(s):  
Barbara H McGovern ◽  
Christopher B Ford ◽  
Matthew R Henn ◽  
Darrell S Pardi ◽  
Sahil Khanna ◽  
...  
Keyword(s):  
Bile Acid ◽  
Statistical Significance ◽  
Standard Of Care ◽  
Lessons Learned ◽  
Metagenomic Sequencing ◽  
Double Blind ◽  
Secondary Bile Acid ◽  
Phase 2 Trial ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

Abstract Background Recurrent Clostridioides difficile infection (rCDI) is associated with loss of microbial diversity and microbe-derived secondary bile acids, which inhibit C. difficile germination and growth. SER-109, an investigational microbiome drug of donor-derived, purified spores, reduced recurrence in a dose-ranging, phase (P) 1 study in subjects with multiple rCDIs. Methods In a P2 double-blind trial, subjects with clinical resolution on standard-of-care antibiotics were stratified by age (&lt; or ≥65 years) and randomized 2:1 to single-dose SER-109 or placebo. Subjects were diagnosed at study entry by PCR or toxin testing. Safety, C. difficile–positive diarrhea through week 8, SER-109 engraftment, and bile acid changes were assessed. Results 89 subjects enrolled (67% female; 80.9% diagnosed by PCR). rCDI rates were lower in the SER-109 arm than placebo (44.1% vs 53.3%) but did not meet statistical significance. In a preplanned analysis, rates were reduced among subjects ≥65 years (45.2% vs 80%, respectively; RR, 1.77; 95% CI, 1.11–2.81), while the &lt;65 group showed no benefit. Early engraftment of SER-109 was associated with nonrecurrence (P &lt; .05) and increased secondary bile acid concentrations (P &lt; .0001). Whole-metagenomic sequencing from this study and the P1 study revealed previously unappreciated dose-dependent engraftment kinetics and confirmed an association between early engraftment and nonrecurrence. Engraftment kinetics suggest that P2 dosing was suboptimal. Adverse events were generally mild to moderate in severity. Conclusions Early SER-109 engraftment was associated with reduced CDI recurrence and favorable safety was observed. A higher dose of SER-109 and requirements for toxin testing were implemented in the current P3 trial. Clinical Trials Registration NCT02437487, https://clinicaltrials.gov/ct2/show/NCT02437487?term=SER-109&draw= 2&rank=4.

The significance of acute kidney injury in Clostridioides difficile infection

2020 ◽  
Author(s):  
Tomer Avni ◽  
Hani Hammud ◽  
Oranit Itzhaki ◽  
Anat Gafter‐Gvili ◽  
Benaya Rozen‐Zvi ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Kidney Injury ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

scholarly journals 1008. The Reduction of Fluoroquinolone Prescribing in Rural Vermont Hospitals

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S354-S355
Author(s):  
Lindsay Smith ◽  
John W Ahern
Keyword(s):  
Antimicrobial Stewardship ◽  
Antimicrobial Agents ◽  
Pharmacist Intervention ◽  
Critical Access Hospitals ◽  
Clostridioides Difficile ◽  
Department Of Health ◽  
Core Elements ◽  
Clostridioides Difficile Infection ◽  
Black Box Warnings ◽  
Prescribing Trend

Abstract Background In 2017 The Joint Commission required all hospitals irrespective of size to implement antimicrobial stewardship programs (ASPs) using the CDC core elements (CE) for antimicrobial stewardship (AS). Critical access and rural community hospitals have struggled with developing effective ASPs. Many ASPs seek to reduce fluoroquinolone (FQ) prescribing due to its high risk for drug-drug interactions, risk of Clostridioides difficile infection, and numerous side effects, including five black box warnings from the FDA. Methods We contracted with the Vermont Department of Health to help rural VT hospitals develop ASPs that are compliant with the CDC CE for AS. Six of Vermont’s 13 hospitals were recruited between June – December 2017 (Table 1). Each hospital obtained antibiotic usage (AU) data in grams (g)/1000 (1k) patient-days (PD) from their electronic medical record (EMR), starting from January 2017. All identified FQ as frequently prescribed antimicrobials. Each hospital had unique interventions to decrease FQ prescribing (Table 1), including orderset changes and pharmacist intervention. Monthly combined FQ (ciprofloxacin + levofloxacin) administration data were collected in g/1K PD. AU data from each hospital were summed and expressed as total FQ g/1000 patient-days. The FQ prescribing trend was analyzed by linear regression. Results Prior to implementing ASP, there was a combined FQ rate of 69 g/1K PD. After 20 months of ASP interventions, combined FQ prescribing decreased to 26 g/1K PD (Figure 1, R= 0.9797, P < 0.001). This trend is also significant for each individual FQ: ciprofloxacin (R=0.8364, P < 0.05) and levofloxacin (R= 0.9801, P < 0.01). Conclusion Rural and critical access hospitals can have successful antimicrobial stewardship programs. We have shown that rural hospitals in Vermont (1) can extract AU data from their EMR, (2) develop interventions to decrease high use antimicrobial agents, and (3) be successful in decreasing FQ prescribing in less than 2 years. Disclosures All authors: No reported disclosures.

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