scholarly journals 14. Effects of an Opt-Out Protocol for Antibiotic De-escalation among Selected Patients with Suspected Sepsis: The DETOURS Trial

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S10-S11
Author(s):  
Rebekah W Moehring ◽  
Michael E Yarrington ◽  
Bobby G Warren ◽  
Yuliya Lokhnygina ◽  
Erica Atkinson ◽  
...  
Keyword(s):  
Antibiotic Therapy ◽  
Controlled Trial ◽  
Positive Culture ◽  
Empiric Therapy ◽  
Flow Diagram ◽  
Suspected Sepsis ◽  
Material Support ◽  
Opt Out ◽  
Days Of Therapy ◽  
And Control

Abstract Background Sepsis guidelines recommend daily review to de-escalate or stop antibiotics in appropriate patients. We conducted a randomized controlled trial (NCT03517007) of an opt-out protocol to decrease unnecessary antibiotics in selected patients with suspected sepsis. Methods We evaluated non-ICU adults remaining on broad-spectrum antibiotics with negative blood cultures at 48-96 hours at ten U.S. hospitals during September 2018-May 2020. A 23-item safety check excluded patients with ongoing signs of infection, concerning or inadequate microbiologic data, or high-risk conditions (Figure 1). Eligible patients were randomized to the opt-out protocol vs. usual care. The primary outcome was 30-day post-enrollment antibacterial days of therapy (DOT). Clinicians caring for intervention patients were contacted by a pharmacist or physician to encourage antibiotic discontinuation or de-escalation using opt-out language, discuss rationale for continuing antibiotics, working diagnosis, and de-escalation and duration plans. Hurdle models separately compared the odds of antibiotic continuation and DOT distributions among those who continued antibiotics. Components of the De-Escalating Empiric Therapy: Opting-OUt of Rx in Selected patients with Suspected Sepsis (DETOURS) Trial Protocol Results Among 9606 screened, 767 (8%) were enrolled (Figure 2). Common reasons for exclusion were antibiotics given prior to blood culture (35%), positive culture from non-blood sites (26%), and increased oxygen requirement (21%). Intervention patients had 32% lower odds of antibiotic continuation (79% vs. 84%, OR 0.68, 95% confidence interval [0.47, 0.98]). DOT distributions among those who continued antibiotics were similar (ratio of means 1.06 [0.88-1.26], Figure 3). Fewer intervention patients were exposed to extended-spectrum agents (38% vs. 44%). Common reasons for continuing antibiotics were treatment of localized infection (76%) and belief that stopping antibiotics was not safe (31%). Safety outcomes such as mortality, readmission, sepsis relapse, C. difficile, and length of stay did not differ. DETOURS Trial Flow Diagram Flow of participants through the DETOURS Trial. Observed Days of Antibiotic Therapy Among Intervention and Control Subjects in the DETOURS Trial Post-enrollment days of antibiotic therapy among 767 DETOURS Trial participants in 10 US acute care hospitals within 30 days after enrollment. Dark pink color indicates percent overlap between intervention (purple) and control (light pink) groups. Conclusion In this patient-level randomized trial of a stewardship intervention, the opt-out de-escalation protocol targeting selected patients with suspected sepsis resulted in more antibiotic discontinuations but did not affect safety events. Disclosures Rebekah W. Moehring, MD, MPH, UpToDate, Inc. (Other Financial or Material Support, Author Royalties) Michael Z. David, MD PhD, GSK (Board Member) Michael Klompas, MD, MPH, UpToDate (Other Financial or Material Support, Chapter Author)

scholarly journals 1027. Vancomycin Use in Community-Acquired Pneumonia: Assessing Inappropriate Therapy

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S361-S362
Author(s):  
Timothy Shan ◽  
Sara J Gore ◽  
Caitlin M McCracken ◽  
Gregory B Tallman ◽  
Haley K Holmer ◽  
...  
Keyword(s):  
Risk Factors ◽  
Positive Culture ◽  
Empiric Therapy ◽  
Community Acquired Pneumonia ◽  
University Hospital ◽  
Inappropriate Therapy ◽  
Definitive Therapy ◽  
Days Of Therapy ◽  
Risk Patients ◽  
The Impact

Abstract Background Current Infectious Disease Society of America guidelines recommend anti-methicillin-resistant Staphylococcus aureus(MRSA) agents for treatment of community-acquired pneumonia (CAP) only in specific high-risk patients. There are limited data on duration of vancomycin use that is appropriate in hospitalized patients with CAP. The objective of this study was to evaluate the use of vancomycin for CAP among inpatients. Methods We conducted a retrospective cohort study of inpatients at Oregon Health and Science University Hospital from August 1st, 2017 to July 31st, 2018 who received IV vancomycin and had a pneumonia encounter ICD-9 diagnosis code. Patients with hospital or ventilator-associated pneumonia were excluded. Appropriate therapy was defined as empiric therapy with known risk-factors, concordant therapy with no de-escalation option, or concurrent sepsis or febrile neutropenia. Vancomycin appropriateness was assessed based on medical history and microbiology for both empiric and definitive therapy. We characterized patients receiving inappropriate therapy and calculated the proportion of inappropriate days of therapy (DOT). Results We identified 52 patients with CAP who were treated with vancomycin for a median of 2 DOT (Interquartile Range (IQR): 1–3). Approximately 21% (11/52) of patients had risk factors warranting vancomycin empiric therapy and 42% (22/52) had concurrent sepsis. Nine CAP patients received inappropriate courses of vancomycin, median of 1 day (IQR: 1–2.25) of inappropriate therapy. The most common reason for classifying use as inappropriate was a positive culture for organisms other than MRSA. Patients receiving inappropriate therapy were more frequently transferred from another hospital (44% vs. 30%, P = 0.22). Overall, 16% (20/125) of vancomycin DOT were inappropriate. Conclusion In our study,CAP patients accounted for a small number of pneumonia patients who received vancomycin. The median inappropriate DOT was relatively short, possibly indicating that identification and de-escalation was performed quickly. Further work is required to determine the impact of these findings on patients. Disclosures All authors: No reported disclosures.

Prevention of Fungal Peritonitis with Nystatin Prophylaxis in Patients Receiving CAPD

2007 ◽  
Vol 27 (5) ◽  
pp. 531-536 ◽  
Author(s):  
Ping-Nam Wong ◽  
Kin-Yee Lo ◽  
Gensy M.W. Tong ◽  
Shuk-Fan Chan ◽  
Man-Wai Lo ◽  
...  
Keyword(s):  
Antibiotic Therapy ◽  
Large Scale ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Control Group ◽  
Fungal Peritonitis ◽  
Kaplan Meier ◽  
Prospective Randomized Controlled Trial ◽  
And Control

Objective Fungal peritonitis (FP) is a serious complication of continuous ambulatory peritoneal dialysis (CAPD), being associated with significant morbidity and mortality. The role of nystatin prophylaxis during antibiotic therapy in the prevention of FP remains controversial, especially in programs with a modest or low baseline FP rate. The aim of the present study was to evaluate the effect of nystatin prophylaxis on the occurrence of FP in programs with a relatively modest baseline FP rate. Patients and Methods Incident and prevalent patients receiving CAPD between April 1995 and April 2005 at our center were included and divided into 2 groups. The control group included 320 patients (total follow-up 8875 patient-months) being treated without nystatin before October 1999; the nystatin group included 481 patients (total follow-up 13725 patient-months) being treated after October 1999. Nystatin tablets (500000 units, 4 times per day) were given orally during whatever use of antibiotics to cover the whole course of antibiotic therapy. Occurrence of FP and antibiotic-related FP (AR-FP) in patients with and without nystatin prophylaxis was compared. Results The two groups were of similar age but the nystatin group had a significantly higher percentage of diabetics. In addition, the nystatin group had a higher proportion of patients using disconnecting twin-bag exchange systems and had a significantly lower peritonitis rate compared with the control. There were 13 and 14 episodes of FP in the nystatin and control groups respectively. The fungal peritonitis rate of the nystatin group was slightly lower than that of the control group (0.011 vs 0.019 per patient-year) but it did not reach statistical significance. There was, however, a significant decrease in the incidence and proportion of AR-FP in the nystatin group compared with the control group, which persisted even after adjustment for the peritonitis rate. Kaplan–Meier analysis further demonstrated significantly better AR-FP-free survival in the nystatin group compared with the control group. No significant side effects were observed for nystatin. Subgroup analyses in patients of the 2 different connecting systems revealed a similar but nonsignificant trend toward reduction of AR-FP in patients given nystatin prophylaxis. Conclusion Oral nystatin prophylaxis might prevent the occurrence of AR-FP in CAPD patients, resulting in a trend toward reduction in the incidence of FP even in programs with a modest baseline FP rate. A large scale, prospective, randomized controlled trial is needed to further examine this issue.

scholarly journals A modified Delphi approach to develop a trial protocol for antibiotic de-escalation in patients with suspected sepsis

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Michael E. Yarrington ◽  
Rebekah W. Moehring ◽  
Michael Z. David ◽  
Keith W. Hamilton ◽  
Michael Klompas ◽  
...  
Keyword(s):  
Expert Panel ◽  
Controlled Trial ◽  
Signs And Symptoms ◽  
Severe Illness ◽  
Trial Protocol ◽  
Suspected Sepsis ◽  
Electronic Survey ◽  
Modified Delphi ◽  
Delphi Approach ◽  
Opt Out

Abstract Background: Early administration of antibiotics in sepsis is associated with improved patient outcomes, but safe and generalizable approaches to de-escalate or discontinue antibiotics after suspected sepsis events are unknown. Methods: We used a modified Delphi approach to identify safety criteria for an opt-out protocol to guide de-escalation or discontinuation of antibiotic therapy after 72 hours in non-ICU patients with suspected sepsis. An expert panel with expertise in antimicrobial stewardship and hospital epidemiology rated 48 unique criteria across 3 electronic survey rating tools. Criteria were rated primarily based on their impact on patient safety and feasibility for extraction from electronic health record review. The 48 unique criteria were rated by anonymous electronic survey tools, and the results were fed back to the expert panel participants. Consensus was achieved to either retain or remove each criterion. Results: After 3 rounds, 22 unique criteria remained as part of the opt-out safety checklist. These criteria included high-risk comorbidities, signs of severe illness, lack of cultures during sepsis work-up or antibiotic use prior to blood cultures, or ongoing signs and symptoms of infection. Conclusions: The modified Delphi approach is a useful method to achieve expert-level consensus in the absence of evidence suifficient to provide validated guidance. The Delphi approach allowed for flexibility in development of an opt-out trial protocol for sepsis antibiotic de-escalation. The utility of this protocol should be evaluated in a randomized controlled trial.

scholarly journals Unintended Consequences of MRSA Infection: Empiric Non-MRSA Antibiotic Use and Resultant Clostridioides difficile Infection

2020 ◽  
Vol 41 (S1) ◽  
pp. s421-s422
Author(s):  
Anastasiia S. Weiland ◽  
Julia Y. Lu ◽  
Caleb S. Chen ◽  
Thomas Tjoa ◽  
Raveena D. Singh ◽  
...  
Keyword(s):  
Antibiotic Therapy ◽  
Controlled Trial ◽  
Antibiotic Use ◽  
Medication Administration ◽  
Multidrug Resistant ◽  
Unintended Consequences ◽  
Empiric Antibiotic Therapy ◽  
Clostridioides Difficile ◽  
Days Of Therapy ◽  
Mrsa Infection

Background: Methicillin-resistant Staphylococcus aureus (MRSA) is responsible for the largest number of invasive infections due to a multidrug-resistant pathogen. Approximately 10% of hospitalized carriers will experience invasive MRSA disease in the year following discharge incurring antibiotic therapy beyond focused treatment of MRSA. Objective: We aimed to quantify the extent of non-MRSA empiric antibiotics incurred by MRSA infections and further assess the risk of Clostridioides difficile Infection (CDI) as a result of treatment of MRSA infection. Methods: The CLEAR Trial was a postdischarge randomized controlled trial of 2,121 MRSA carriers comparing MRSA education alone to education plus repeated decolonization that demonstrated a 30% reduction in MRSA infection and a 17% reduction in all-cause infection attributable to decolonization in the year following hospital discharge (Huang SS, NEJM 2019). We included all hospitalization outcomes due to MRSA infection in the CLEAR Trial with detailed medication administration records to quantify unintended consequences of MRSA infection related to empiric non-MRSA antibiotic use and resultant CDI. Full-text medical records were reviewed with a standardized abstraction form to collect inpatient administered antibiotics and hospital-associated CDI. Results: In total,154 hospitalizations due to MRSA infection with a mean length-of-stay of 10.6 days were identified. During 25 hospitalizations (16.2%), patients received only anti-MRSA antibiotics. During the remaining 129 (83.8%) hospitalizations, patients received a mean of 1.6 distinct non-MRSA antibiotics totaling a mean of 6.6 days of therapy (DOT). Empiric non-MRSA therapy was given for 3.2 DOT before MRSA culture results became available and was continued for an additional 3.4 DOT afterward. Among all 849 non-MRSA DOT, the most common were due to piperacillin-tazobactam (293 DOT, 34.5%), levofloxacin (105 DOT, 12.4%), and metronidazole (93 DOT, 11.0%). Across all 154 hospitalizations, a mean of 5.5 non-MRSA DOT was calculated per MRSA hospitalization, with 6 CDI cases (3.9%) as a direct sequelae of empiric non-MRSA antibiotics provided for MRSA infection. Conclusions: Hospitalization for MRSA infection results in extensive non-MRSA empiric antibiotic therapy both before and after MRSA culture results are known. This antibiotic use is associated with a 3.9% risk of CDI that exceeds the national risk of acquiring CDI (3.2 per 1,000 admissions) by 12-fold during any hospital stay (Barrett ML, AHRQ 2018). The CLEAR Trial findings that postdischarge decolonization reduces MRSA infection and hospitalization by 30% suggests that decolonization may also reduce non-MRSA antibiotic use and CDI in this population.Funding: NoneDisclosures: None

scholarly journals 2196. Impact of Rapid Discontinuation of Empiric Vancomycin in Patients with Hospital-Acquired or Healthcare-Associated Pneumonia and Absence of Adequate Respiratory Tract Culture Data

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S748-S748
Author(s):  
Alanna H Rufe ◽  
Linda S Johnson
Keyword(s):  
Antibiotic Therapy ◽  
Cohort Analysis ◽  
Empiric Therapy ◽  
Post Intervention ◽  
Days Of Therapy ◽  
Antigen Tests ◽  
Healthcare Associated ◽  
Hospital Acquired ◽  
The Impact ◽  
Post Period

Abstract Background Vancomycin is a commonly utilized empiric therapy for patients with hospital-acquired and healthcare-associated pneumonia (HAP and HCAP). De-escalation is encouraged in the guidelines but not commonly performed in the absence of culture data. Studies have shown that in certain low-risk patients, vancomycin may not be necessary. A clinical criterion document was implemented in 2018 at CHI Memorial to facilitate rapid de-escalation of vancomycin. This study aims to assess the impact of early discontinuation of vancomycin in patients with HAP or HCAP and no respiratory culture. Methods A retrospective cohort analysis was conducted in adult inpatients who presented from September to December 2017 and 2018 with HAP or HCAP, no respiratory culture within 72 hours, and at most one risk factor for MRSA. Patients who did not meet criteria for de-escalation, were receiving antibiotics for an extrapulmonary infection, or had a pathogen identified from blood or urinary antigen tests were excluded. The primary endpoint was vancomycin days of therapy pre- vs. post-intervention. Secondary endpoints include vancomycin re-start, subsequent respiratory culture growing MRSA, intensive care unit (ICU) and total length of stay, total days of antibiotic therapy, total days of alternate anti-MRSA therapy and in-hospital mortality in de-escalated vs. non-de-escalated patients. Results A total of 66 patient were included; 25 in the pre- and 41 in the post-period. The median age was 83 in the pre- and 68 in the post-period, with 20% of patients being initiated in the ICU and one patient with HAP in each group. There was no difference in median days of vancomycin therapy in the pre- vs. post-intervention period (4 days [3–5] vs. 4 days [3–5]) P = 0.583. There were 37 patients not de-escalated and 29 patients rapidly de-escalated. Total days of inpatient antibiotic therapy was significantly lower in the de-escalated group (7 days [5–9] vs. 5 days [4–7]) P = 0.037. No other significant differences were noted (Table 2). Conclusion There was no difference in vancomycin days of therapy after the implementation of this pharmacist-led initiative. However, discontinuing vancomycin within 72 hours was safe in patients with HCAP and was associated with decreased days of inpatient antibiotic therapy. Disclosures All authors: No reported disclosures.

scholarly journals 92. Successful Scale-up of an Intervention to Decrease Unnecessary Urine Cultures Led to Improvements in Antibiotic Use

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S177-S177
Author(s):  
Larissa Grigoryan ◽  
John Van ◽  
David J Ramsey ◽  
Melanie Goebel ◽  
Annette Walder ◽  
...  
Keyword(s):  
Antibiotic Therapy ◽  
Antibiotic Stewardship ◽  
Long Term Care ◽  
Urine Culture ◽  
Antibiotic Use ◽  
Term Care ◽  
Days Of Therapy ◽  
Bed Days ◽  
And Control

Abstract Background We previously conducted a successful single-site intervention to improve compliance with antibiotic stewardship guidelines for asymptomatic bacteriuria (ASB). In this dissemination project we explored whether we could facilitate antibiotic stewardship for ASB at a distance, in four distant VA medical centers. Methods Each site champion received a decision-aid algorithm, interactive teaching based on actual cases, and support with data collection. The focus of the intervention was on teaching providers in acute and long-term care to avoid ordering unnecessary urine cultures. We measured DOT (days of antibiotic therapy), LOT (length of antibiotic therapy) and urine cultures ordered per 1,000 bed-days monthly in the intervention sites and four matched control sites. Both DOT and LOT captured all systemic antibiotics initiated on day -1 to +2 of a urine culture order. We conducted segmented regression analyses for the three outcomes for the intervention and control sites separately, and difference in differences analysis for urine cultures. Results Over the baseline and intervention years, 12,260 urine cultures were ordered in 6823 unique patients in the acute and long-term care wards at the 8 sites. During the baseline year, the average urine-culture related DOT was 45.1 and LOT was 34.7, per 1000 bed-days. Both DOT and LOT decreased significantly over the intervention period in the intervention sites (p < 0.05 for both); a significant decrease was not seen in the control sites (Figures 1 and 2). For urine cultures, at baseline the average number of cultures ordered per month per 1000 bed-days was 13.6. Both intervention and control sites saw a significant decrease in urine cultures over the baseline year. In the intervention year, urine cultures continued to decrease in the intervention sites (p=0.001) but increased in the control sites (Figure 3). Figure 1. Days of Therapy (DOT) per 1,000 bed-days, for antibiotics started within -1 to +2 days of a urine culture Figure 2. Length of Therapy (LOT) per 1,000 bed-days, for antibiotics started within -1 to +2 days of a urine culture Figure 3. Urine Cultures per 1,000 bed-days Conclusion Our externally-facilitated intervention significantly decreased local antibiotic use (both DOT and LOT) and urine cultures. Unnecessary urine cultures are a major driver of unnecessary antibiotic use for ASB, and our focus on diagnostic stewardship for urine cultures led to antibiotic stewardship. Our next step will be to further disseminate our intervention to other VA facilities. Disclosures All Authors: No reported disclosures

Study to Evaluate Efficacy of Vajravatakmaņdura in Iron Deficiency Anemia in Adolescent Girls: A Randomized Controlled Trial

2018 ◽  
Vol 3 (01) ◽  
Author(s):  
Rashmi Pareek Ayatullah Hosne Asif ◽  
Nisha Kumari Ojha
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Adolescent Girls ◽  
Controlled Trial ◽  
Control Programme ◽  
Deficiency Anemia ◽  
Group A ◽  
The Government ◽  
Trial Drug ◽  
And Control

Background: Anemia in adolescent girls possess greatest burden on their health as it leads to poor cognitive development, poor reproductive health and if not treated may lead to intrauterine growth retardation in their developing fetus. The prevalence of anemia among adolescent is 27% in developing country and 6% in developed country. The Government of India has launched National Anemia Control Programme, to prevent and control anaemia in children and adolescents. But the problem is still persisting because of many issues like - poor palatability, intolerance to the drug used, poor absorption of the drugs used, constipation, discoloration of stool, unpleasant odor and taste etc. result in poor compliance and therefore non adherence to the therapy which finally results in poor improvement. By looking at the magnitude of the problem, an Ayurveda drug Vajravatakmandura has been selected for the study and the present study was undertaken to evaluate the efficacy of the trial drug in iron deficiency anemia in adolescent girls. Material and methods: 100 subjects satisfying inclusion and exclusion criteria were selected and were randomly divided in two groups. In group A, the trial drug Vajravatakmaņdura was administered and in group B, IFA tablets were given for two month of duration with follow up at every fortnight. Result: Both the trial and control groups showed extremely significant result over subjective parameters. Trial drug Vajravatakmaņdura in group A was found more effective over the subjective parameters - weakness, palpitation, pallor and loss of appetite with % gain of 39.77%, 39.39%, 39.17%, 38.09% respectively. Statistical analysis between before and after treatment findings of objective parameters, extremely significant (P less than 0.0001) improvement was found in both groups in all parameters, except for RBC count in group A, which was significant. No adverse effects were reported during entire period of study by any of the patients in trial group treated with trial drug. Conclusion: The trial drug “Vajravatakmandura” is effective, safe and palatable for the management of iron deficiency anemia in adolescent girls.

scholarly journals Detection of Domestic Violence and Abuse by Community Mental Health Teams Using the BRAVE Intervention: A Multicenter, Cluster Randomized Controlled Trial

2021 ◽  
pp. 088626052110041
Author(s):  
Roos Ruijne ◽  
Cornelis Mulder ◽  
Milan Zarchev ◽  
Kylee Trevillion ◽  
Roel van Est ◽  
...  
Keyword(s):  
Mental Health ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Referral Rates ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control ◽  
Domestic Violence And Abuse

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended.

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