scholarly journals 197. Healthcare Resource Utilization and Costs Associated with Inappropriate and Suboptimal Prescribing of Antibiotics for Uncomplicated Urinary Tract Infection in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S120-S120
Author(s):  
Rena Moon ◽  
Alen Marijam ◽  
Fanny S Mitrani-Gold ◽  
Daniel C Gibbons ◽  
Alex Kartashov ◽  
...  
Keyword(s):  
Applied Sciences ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Claims Data ◽  
Healthcare Resource ◽  
The United States ◽  
Charlson Comorbidity Index Score ◽  
Uncomplicated Urinary Tract Infection

Abstract Background Despite well-established guidelines for urinary tract infection (UTI) treatment, prescribing practices vary. We examined the association between inappropriate (IA) or suboptimal (SO) antibiotic (AB) prescribing (RX) and hospitalization, healthcare resource use (HRU), and costs among patients with uncomplicated UTI (uUTI) in the US. Methods This retrospective cohort study used linked Premier Healthcare/Optum claims data from female outpatients (≥ 12 years old) with a uUTI diagnosis (January 1, 2013 to December 31, 2018). Patients with complicated UTIs (eg, urological abnormalities, medications/procedures associated with complicated UTI, or intravenous AB receipt at index) were excluded. HRU and costs between patients with IA/SO and appropriate and optimal (AP&OP) AB RX (defined in Table 1) were assessed from Optum claims data during index episode (within 28 days of index) and 12-month follow-up. Table 1. Definitions of appropriateness of AB RX Results Of 5870 patients, 1856 (31.6%) had IA and 1255 (21.4%) had SO AB RX. Patients with IA/SO AB RX (47.1%) were older and more likely to have a Charlson Comorbidity Index score > 0 than those with AP&OP AB RX (52.9%; Table 2). During index episode, mean ambulatory care and pharmacy claims were significantly higher for IA/SO versus AP&OP AB RX (8.0 vs 6.3, 3.3 vs 2.6, respectively; p < 0.01), and total HRU cost per patient was higher for IA/SO (&2616) versus AP&OP AB RX (&649; p < 0.01). During follow-up, 267 (9.7%) patients with IA/SO AB RX had a UTI-related emergency department (ED) visit versus 202 (6.5%) patients with AP&OP AB RX (p < 0.001). Mean UTI-related HRU costs were significantly higher for IA/SO (&5048) versus AP&OP AB RX (&3633; p = 0.01). After adjusting for patient characteristics, patients with IA/SO AB RX were 40% more likely than those with AP&OP AB RX to have a UTI-related ED visit (odds ratio 1.40; 95% confidence interval 1.15–1.71) during follow-up (Table 3). Adjusted HRU costs for IA/SO AB RX (vs AP&OP) were numerically higher for index uUTI episode (by &1772), and UTI-related (by &1102) and all-cause (by &1528) charges during follow-up (Figure). Table 2. Baseline characteristics of patients stratified by appropriateness of AB RX Table 3. Associations of AP&OP AB RX and HRU charges for index episode and 12-month follow-up Figure. Total 12-month UTI-related and all-cause visit charges (adjusted), stratified by appropriateness of AB RX at index and during follow-up Conclusion IA/SO AB RX was associated with higher overall and UTI-related HRU and costs during index episode and 12-month follow-up, highlighting a need for education on applying prescription guidelines and the use of culture-based RX. Disclosures Rena Moon, MD, Premier Applied Sciences, Premier Inc. (Employee) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Daniel C. Gibbons, PhD, GlaxoSmithKline plc. (Employee, Shareholder) Alex Kartashov, PhD, Premier Applied Sciences, Premier Inc. (Employee) Ning Rosenthal, MD, Premier Applied Sciences, Premier Inc. (Employee, Shareholder) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

scholarly journals A prospective, follow up study to assess guidelines compliance in uncomplicated urinary tract infection

2020 ◽  
Vol 9 (8) ◽  
pp. 4292
Author(s):  
Manisha Bisht ◽  
PreetinderSingh Manshahia ◽  
Ankur Mittal ◽  
Mohit Bhatia ◽  
ShailendraS Handu
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Uncomplicated Urinary Tract Infection ◽  
Follow Up Study

scholarly journals Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis)

2020 ◽  
Vol 64 (7) ◽  
Author(s):  
J. Scott Overcash ◽  
Courtney A. Tiffany ◽  
Nicole E. Scangarella-Oman ◽  
Caroline R. Perry ◽  
Yu Tao ◽  
...  
Keyword(s):  
Urinary Tract Infection ◽  
Steady State ◽  
Urinary Tract ◽  
Tract Infection ◽  
Clinical Success ◽  
Plasma Concentrations ◽  
Maximum Plasma ◽  
Uncomplicated Urinary Tract Infection ◽  
Efficacy Evaluation

ABSTRACT Gepotidacin, a triazaacenaphthylene bacterial type II topoisomerase inhibitor, is in development for treatment of uncomplicated urinary tract infection (uUTI). This phase 2a study in female participants with uUTI evaluated the pharmacokinetics (primary objective), safety, and exploratory efficacy of gepotidacin. Eligible participants (n = 22) were confined to the clinic at baseline, received oral gepotidacin at 1,500 mg twice daily for 5 days (on-therapy period; days 1 to 5), and returned to the clinic for test-of-cure (days 10 to 13) and follow-up (day 28 ± 3) visits. Pharmacokinetic, safety, clinical, and microbiological assessments were performed. Maximum plasma concentrations were observed approximately 1.5 to 2 h postdose. Steady state was attained by day 3. Urinary exposure over the dosing interval increased from 3,742 μg·h/ml (day 1) to 5,973 μg·h/ml (day 4), with trough concentrations of 322 to 352 μg/ml from day 3 onward. Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends. Clinical success was achieved in 19 (86%) and 18 (82%) of 22 participants at test-of-cure and follow-up visits, respectively. Eight participants had a qualifying baseline uropathogen (growth; ≥105 CFU/ml). A therapeutic (combined clinical and microbiological [no growth; <103 CFU/ml]) successful response was achieved in 6 (75%) and 5 (63%) of 8 participants at test-of-cure and follow-up visits, respectively. Plasma area under the free-drug concentration-time curve over 24 h at steady state divided by the MIC (fAUC0–24/MIC) and urine AUC0–24/MIC ranged from 6.99 to 90.5 and 1,292 to 121,698, respectively. Further evaluation of gepotidacin in uUTI is warranted. (This study has been registered in ClinicalTrials.gov under identifier NCT03568942.)

scholarly journals 1434. Treatment Patterns, Healthcare Resource Use, and Associated Costs in Females with Uncomplicated Urinary Tract Infection in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S798-S799
Author(s):  
Rena Moon ◽  
Alen Marijam ◽  
Fanny S Mitrani-Gold ◽  
Daniel C Gibbons ◽  
Alex Kartashov ◽  
...  
Keyword(s):  
Applied Sciences ◽  
Urinary Tract ◽  
Resource Use ◽  
Healthcare Resource ◽  
Uncomplicated Urinary Tract Infection ◽  
Healthcare Resource Use ◽  
Ed Visits ◽  
Tract Infections ◽  
Switch Group

Abstract Background Urinary tract infections (UTIs) disproportionately affect women and are a substantial burden on healthcare systems. We assessed the effect of antibiotic (AB) switching on UTI recurrence, healthcare resource use (HRU), and related costs among adolescent and adult females in the US with uncomplicated UTIs (uUTIs). Methods This retrospective cohort study used US Optum claims data (United Healthcare, January 1, 2013–December 31, 2018). Eligible patients were females ≥ 12 years of age with an acute uUTI diagnosis at outpatient or emergency department (ED) visit (index date) and an oral AB prescription within ± 5 days of index. Patients with recurrent UTIs (rUTIs), defined as 2 UTI diagnoses (including index) in 6 months or ≥ 3 UTI diagnoses (including index) in 12 months, were included; those with complicated UTI were excluded. Patients were assigned to two groups: AB switch (≥ 2 filled prescriptions of different AB within 28 days post index [uUTI episode]) and no AB switch. Results In 5870 eligible patients (mean age 44.5 years; 76.6% White), ciprofloxacin (CIP; 38.6%), nitrofurantoin (NFT; 31.4%), and trimethoprim-sulfamethoxazole (TMP-SMX; 25.6%) were the most commonly prescribed first-line ABs at index, and 567 (9.7%) patients switched AB. CIP was switched to NFT and TMP-SMX in 2.0% and 1.7% of patients, respectively. NFT was switched to CIP and TMP-SMX in 2.6% and 1.5% of patients, respectively. TMP-SMX was switched to CIP and NFT in 3.0% and 2.4% of patients, respectively. During index visit, the AB switch group had higher mean ambulatory care and pharmacy claims (both p &lt; 0.001), and higher total mean HRU costs (&2186.4) per patient compared with the no switch group (&1508.8; p = 0.011). More patients had rUTI in the AB switch group (18.9%) versus the no switch group (14.2%; p &lt; 0.001), and more had ED visits in the AB switch group than the no switch group (p &lt; 0.0001) (Table 1). During follow-up, the AB switch group had a higher mean number of uUTI episodes per patient (p &lt; 0.001; Table 1), and more patients had UTI-related ED visits (10.8%) compared with the no switch group (7.7%; p = 0.010; Table 2). Table 1. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013–December 31, 2018, stratified by any switch in AB use during index episode Table 2. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013–December 31, 2018, stratified by any switch in AB use during 12-month follow-up Conclusion US females with uUTI who switched AB had more rUTI cases and increased overall costs and HRU compared with those who did not switch AB, suggesting an unmet need for improved prescribing practices. Disclosures Rena Moon, MD, Premier Applied Sciences, Premier Inc. (Employee) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Daniel C. Gibbons, PhD, GlaxoSmithKline plc. (Employee, Shareholder) Alex Kartashov, PhD, Premier Applied Sciences, Premier Inc. (Employee) Ning Rosenthal, MD, Premier Applied Sciences, Premier Inc. (Employee, Shareholder) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

scholarly journals Patterns of recurring dispensing of guideline antibiotics for uncomplicated urinary tract infection in women over a 5-year period: Longitudinal patterns of recurring dispensings of Dutch guideline UTI antibiotics

2020 ◽  
Author(s):  
Rian C Lelie- van der Zande ◽  
Marcel L Bouvy ◽  
and Martina Teichert
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Community Pharmacies ◽  
Source Population ◽  
Uncomplicated Urinary Tract Infection ◽  
Longitudinal Patterns ◽  
Dutch Guideline ◽  
Dispensing Data

Abstract Background Urinary tract infection (UTI) is one of the most prevalent medical conditions among women seeking primary care. About 20–40% of the women have a UTI recurrence during their lifetime. Objective To provide insight in the patterns of recurring annual dispensing for antibiotics commonly used for UTI treatment in women, aged 18 years or older, during a 5-year follow-up period in the Netherlands. Methods The Dutch Foundation of Pharmaceutical statistics collects dispensing data from more than 90% of all community pharmacies. Pharmacies with complete data between years 2011 and 2017 were included. Women of age 18 years or older with a first dispensing of nitrofurantoin, fosfomycin, or trimethoprim in 2012 and a dispensing of any medication in 2017 were selected. For each year between 2013 and 2017, the proportions of women with recurring dispensing of nitrofurantoin, fosfomycin or trimethoprim were calculated and stratified for age categories. Results Within 1517 eligible community pharmacies, 463 821 women, aged 18 years or older, were dispensed one of the antibiotics in 2012, and 239 292 women still visited the same pharmacy in 2017. About 56% of them received at least one recurring dispensing during 5 years of follow-up. Each year, ~20% of the source population had at least one recurring dispensing. Approximately 2% of the source population had at least one recurring dispensing in each year of follow-up. Conclusions Over the 5-year study period, more than 50% of the source population had at least one recurring dispensing for uncomplicated UTI, most of them with at least 1 year without UTI dispensing in between.

scholarly journals 1281. Longitudinal and Spatial Variation in the Human Microbiome in a Phase 2a Clinical Study of Gepotidacin in Adult Females with Uncomplicated Urinary Tract Infection

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S655-S656
Author(s):  
Andrea Nuzzo ◽  
Stephanie Van Horn ◽  
Christopher Traini ◽  
Caroline R Perry ◽  
Etienne Dumont ◽  
...  
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Human Microbiome ◽  
Alpha Diversity ◽  
Variable Region ◽  
Uncomplicated Urinary Tract Infection ◽  
Time Points ◽  
Microbiota Diversity

Abstract Background Gepotidacin (GSK2140944) is a first in class novel oral triazaacenaphthylene bacterial topoisomerase inhibitor. In this study, we evaluated the potential impact of orally administered gepotidacin on the human microbiome, across three body-sites and at three specific time-points, as an exploratory endpoint in a Phase 2a clinical trial for the treatment of uncomplicated Urinary Tract Infection (uUTI) (ClinicalTrials.gov: NCT03568942). Methods Through DNA sequencing of the 16S rRNA variable region 4, we analyzed samples collected with consent from study subjects from the gastrointestinal tract or GIT (stool), pharyngeal cavity (saliva swabs) and vagina (vaginal swabs). Samples were taken at three time points which were pre-dosing (Day 1), end of dosing (Day 5) and follow-up visit (Day 28 ±3 days). A total of 156 samples were collected and 141 samples passed quality control criteria for DNA sequence analyses. Using a rigorous computational work-flow, changes in microbiome diversity and relative abundances of microbial species were quantified. Results Time series analyses showed that microbiota alpha diversity dropped, relative to pre-dose, by the end of gepotidacin dosing but trended a return trajectory to original pre-dose levels by the follow-up visit, for all body sites (Figure). However, the character and extent of the microbiota changes varied by location. The relative ordering from least to greatest changes in microbiota diversity of body sites is vaginal, pharyngeal and GIT. We found no statistically significant occurrences of pathogen related taxa, such as Clostridioides or Enterobacterales spp., at the final timepoints. Conclusion Since gepotidacin is both orally dosed and elimination includes the biliary route, it was predicted to affect the GIT microbiome, however changes in the distal pharyngeal and vaginal microbiota were also observed. Gepotidacin alteration of the endogenous microbial community appears to be temporary and reversible as microbiota diversity rebounded to near pre-dosing status within a period of several weeks. Our study illustrates how microbiome analyses in antibiotic clinical studies can quantify patterns of microbiota disruption and recovery. Disclosures Andrea Nuzzo, PHD, GlaxoSmithKline (Employee) Stephanie Van Horn, B.Sc., GlaxoSmithKline (Employee) Christopher Traini, PHD, GlaxoSmithKline (Employee) Caroline R. Perry, PhD, GlaxoSmithKline (Employee) Etienne Dumont, MD, GlaxoSmithKline (Employee) Nicole Scangarella-Oman, MS, GlaxoSmithKline plc. (Employee, Shareholder) David Gardiner, MD, GlaxoSmithKline (Employee) James R. Brown, PhD, GlaxoSmithKline (Employee)

scholarly journals Cranberry Extract for Symptoms of Acute, Uncomplicated Urinary Tract Infection: A Systematic Review

Antibiotics ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. 12
Author(s):  
Oghenekome A. Gbinigie ◽  
Elizabeth A. Spencer ◽  
Carl J. Heneghan ◽  
Joseph J. Lee ◽  
Christopher C. Butler
Keyword(s):  
Clinical Trials ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Antibiotic Use ◽  
Risk Of Bias ◽  
Current Evidence ◽  
Cochrane Library ◽  
Uncomplicated Urinary Tract Infection ◽  
Cranberry Juice

Background: Effective alternatives to antibiotics for alleviating symptoms of acute infections may be appealing to patients and enhance antimicrobial stewardship. Cranberry-based products are already in wide use for symptoms of acute urinary tract infection (UTI). The aim of this review was to identify and critically appraise the supporting evidence. Methods: The protocol was registered on PROSPERO. Searches were conducted of Medline, Embase, Amed, Cinahl, The Cochrane library, Clinicaltrials.gov and WHO International Clinical Trials Registry Platform. We included randomised clinical trials (RCTs) and non-randomised studies evaluating the effect of cranberry extract in the management of acute, uncomplicated UTI on symptoms, antibiotic use, microbiological assessment, biochemical assessment and adverse events. Study risk of bias assessments were made using Cochrane criteria. Results: We included three RCTs (n = 688) judged to be at moderate risk of bias. One RCT (n = 309) found that advice to consume cranberry juice had no statistically significant effect on UTI frequency symptoms (mean difference (MD) −0.01 (95% CI: −0.37 to 0.34), p = 0.94)), on UTI symptoms of feeling unwell (MD 0.02 (95% CI: −0.36 to 0.39), p = 0.93)) or on antibiotic use (odds ratio 1.27 (95% CI: 0.47 to 3.43), p = 0.64), when compared with promoting drinking water. One RCT (n = 319) found no symptomatic benefit from combining cranberry juice with immediate antibiotics for an acute UTI, compared with placebo juice combined with immediate antibiotics. In one RCT (n = 60), consumption of cranberry extract capsules was associated with a within-group improvement in urinary symptoms and Escherichia coli load at day 10 compared with baseline (p < 0.01), which was not found in untreated controls (p = 0.72). Two RCTs were under-powered to detect differences between groups for outcomes of interest. There were no serious adverse effects associated with cranberry consumption. Conclusion: The current evidence base for or against the use of cranberry extract in the management of acute, uncomplicated UTIs is inadequate; rigorous trials are needed.

Long-term follow-up of premature infants with urinary tract infection

2021 ◽  
Author(s):  
Lotem Goldberg ◽  
Yael Borovitz ◽  
Nir Sokolover ◽  
Asaf Lebel ◽  
Miriam Davidovits
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Premature Infants ◽  
Long Term Follow Up
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