scholarly journals An Evaluation of Butoconazole Nitrate 2% Site Release®Vaginal Cream (Gynazole-1®) Compared to Fluconazole 150 mg Tablets (Diflucan®) in the Time to Relief of Symptoms in Patients With Vulvovaginal Candidiasis

2005 ◽  
Vol 13 (4) ◽  
pp. 197-206 ◽  
Author(s):  
Larry S. Seidman ◽  
Campbell K. Skokos
Keyword(s):  
Single Dose ◽  
Treatment Group ◽  
Adverse Events ◽  
Median Time ◽  
The United States ◽  
Vulvovaginal Candidiasis ◽  
Reinfection Rate ◽  
Vaginal Cream ◽  
Butoconazole Nitrate ◽  
Site Release

Background.It is estimated that as many as 13 million cases of vulvovaginal infection occur in the United States annually, the majority of which are the result ofCandida albicansinfection. The symptoms of vulvovaginal infections are often painful and distressing to the patient. The objective of this study was to compare the time to symptomatic relief of vulvovaginal candidiasis (VVC) with butoconazole nitrate 2% Site Release®vaginal cream (Gynazole-1®) and oral fluconazole 150 mg tablets (Diflucan®).Methods.This randomized, open-label, parallel study evaluated 181 female patients with moderate to severe symptoms of VVC. Patients were randomized to single-dose therapy with either butoconazole nitrate 2% Site Release®vaginal cream or fluconazole. The primary outcome measure was the time to onset of first relief of symptoms. Secondary measures included the time to overall relief of symptoms and the reinfection rate over the first 30 days following treatment. The overall safety of both products was investigated through the collection of adverse event reports.Results.The median time to first relief of symptoms occurred at 17.5 h for butoconazole patients as compared to 22.9 h for fluconazole patients (p< 0.001). The time at which 75% of patients experienced first relief of symptoms was 24.5 h versus 46.3 h for butoconazole and fluconazole, respectively (p< 0.001). By 12- and 24-h post-treatment, 44.4% and 72.8% of patients in the butoconazole treatment group reported first relief of symptoms versus 29.1% and 55.7% of patients in the fluconazole group (p= 0.044 andp= 0.024 respectively). In patients experiencing first relief of symptoms within 48 h of dosing, the median time to first relief of symptoms in the butoconazole treatment group was significantly shorter at 12.9 h compared to 20.7 h for the fluconazole treatment group (p= 0.048). There were no significant differences between the two groups with respect to time to total relief of symptoms or reoccurrence of infection within 30 days of treatment. Butoconazole therapy was shown to have fewer reported adverse events, including drug-related adverse events, than fluconazole therapy. Vulvovaginal pruritis and vulvovaginal burning were the most common drug-related adverse events attributed to butoconazole. Headache, diarrhea, nausea, upset stomach and skin sensitivity were the most common drugrelated adverse events attributable to fluconazole.Conclusions.Single-dose butoconazole nitrate 2% Site Release®vaginal cream provides statistically significant improvement in time to first relief of symptoms in the treatment of VVC compared to fluconazole. There is no difference between these two treatments with respect to total relief of symptoms or reinfection rate. Although there was no significant difference in the incidence of adverse events judged by the investigator to be treatment-related, butoconazole treatment did result in fewer patients experiencing adverse events than fluconazole.

scholarly journals 2719. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered in Adults 18–55 Years of Age

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S957-S957
Author(s):  
James Peterson ◽  
James Hedrick ◽  
Judy Pan ◽  
David Neveu ◽  
Emilia Jordanov ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Events ◽  
Conjugate Vaccine ◽  
Geometric Mean ◽  
Safety Data ◽  
The United States ◽  
Phase Iii ◽  
Meningococcal Vaccine ◽  
Post Vaccination ◽  
Quadrivalent Meningococcal Conjugate Vaccine

Abstract Background The MenACYW-TT conjugate vaccine is a quadrivalent meningococcal vaccine that contains tetanus toxoid as carrier protein. The vaccine is intended for global use in all age groups (i.e., individuals 6 weeks of age and older). This Phase III study evaluated the immune lot consistency, and safety and immunogenicity of the vaccine when compared with a licensed quadrivalent meningococcal conjugate vaccine in individuals 10–55 years of age. Methods A randomized, modified double-blind, multi-center study (NCT02842853) was conducted in the United States. The study evaluated 3344 meningococcal vaccine naïve adolescents and adults, who were randomly assigned to receive either a single dose of one of the three lots of MenACYW-TT conjugate vaccine or single dose of Menactra® [MenACWY-D]. Serum bactericidal assay with human complement (hSBA) and rabbit complement (rSBA) was used to measure antibodies against serogroups A, C, W, and Y at baseline before vaccination (Day 0) and 30 days post-vaccination. Safety data were collected up to 6 months post-vaccination. Herein we report the performance of MenACYW-TT in adults 18 through 55 years of age (n = 1,807). Results Immune equivalence was demonstrated across all 3 lots of MenACYW-TT conjugate vaccine based on geometric mean titers (GMTs) for all serogroups. Non-inferiority of immune responses, based on percentages of participants achieving hSBA vaccine seroresponse, was demonstrated between MenACYW-TT and MenACWY-D for all four serogroups at Day 30 compared with baseline. The proportions of individuals (18–55 years) with hSBA ≥ 1:8 following MenACYW-TT administration were higher than those after MenACWY-D administration for all four serogroups (A: 93.5% vs. 88.1%; C: 93.5% vs. 77.8%; W: 94.5% vs. 80.2%; Y: 98.6% vs. 81.2%). A similar trend was observed for post vaccination GMTs in adult participants. Reactogenicity profiles were comparable across study groups. Most unsolicited adverse events were of grade 1 or grade 2 intensity. No vaccine-related serious adverse events were reported. Conclusion MenACYW-TT vaccine was well tolerated and demonstrated a non-inferior immune response compared with the licensed MenACWY-D vaccine when administered as a single dose to meningococcal vaccine naïve adults. Disclosures All authors: No reported disclosures.

scholarly journals Effect of Butoconazole Nitrate 2% Vaginal Cream and Miconazole Nitrate 2% Vaginal Cream Treatments in Patients with Vulvovaginal Candidiasis

1996 ◽  
Vol 4 (6) ◽  
pp. 323-328
Author(s):  
Myra A. Lappin ◽  
Doris C. Brooker ◽  
Carol A. Francisco ◽  
Joan Dorfman
Keyword(s):  
Potassium Hydroxide ◽  
Signs And Symptoms ◽  
Vulvovaginal Candidiasis ◽  
Vaginal Cream ◽  
Miconazole Nitrate ◽  
Symptom Scores ◽  
Cure Rates ◽  
Lost To Follow Up ◽  
Butoconazole Nitrate

In a multicenter, randomized, invesgtigator-blind, parallel study, 398 patients were dispensed topical butoconazole nitrate 2% cream for 3 days (n = 199) or miconazole nitrate 2% cream for 7 days (n = 199) for vaginal use. Efficacy analyses included 254 patients with culture-confirmedCandida(119 butoconazole and 135 miconazole users). Of the 398 patients issued study medication, 9 were lost to follow-up. Therefore, safety analyses included 389 patients (197 butoconazole and 192 miconazole users). Evaluations upon admission and approximately 8 and 30 days post-treatment includedCandidacultures, potassium hydroxide (KOH) wet mounts, and vulvovaginal examinations, with rating of vulvovaginal signs and symptoms using a 4-point scale. Rates of clinical cure (based on sign/symptom scores), microbiologic cure (based on cultures and wet mounts), and therapeutic cure (both clinical and microbiologic cures) were assessed and were to be similar between the regimens. Therapeutic cure rates were 57.8% and 61.4% for butoconazole and miconazole, respectively. Three-day butoconazole treatment was as safe and effective as 7-day miconazole therapy in treating vulvovaginal candidiasis.

scholarly journals 2723. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered in Adolescents 10–17 Years of Age

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S958-S958
Author(s):  
James Peterson ◽  
James Hedrick ◽  
Judy Pan ◽  
David Neveu ◽  
Emilia Jordanov ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Events ◽  
Conjugate Vaccine ◽  
Geometric Mean ◽  
Safety Data ◽  
The United States ◽  
Phase Iii ◽  
Meningococcal Vaccine ◽  
Post Vaccination ◽  
Quadrivalent Meningococcal Conjugate Vaccine

Abstract Background The MenACYW-TT conjugate vaccine is a quadrivalent meningococcal vaccine that contains tetanus toxoid as carrier protein. The vaccine is intended for global use in all age groups (i.e., individuals 6 weeks of age and older). This Phase III study evaluated the immune lot consistency, and safety and immunogenicity of the vaccine when compared with a licensed quadrivalent meningococcal conjugate vaccine in individuals 10–55 years of age. Methods A randomized, modified double-blind, multi-center study (NCT02842853) was conducted in the United States. The study evaluated 3344 meningococcal vaccine naïve adolescents and adults, who were randomly assigned to receive either a single dose of one of the three lots of MenACYW-TT conjugate vaccine or single dose of Menactra® [MenACWY-D]. Serum bactericidal assay with human complement (hSBA) and baby rabbit complement (rSBA) was used to measure antibodies against serogroups A, C, W and Y at baseline before vaccination (Day 0) and 30 days post-vaccination. Safety data were collected up to 6 months post-vaccination. Herein we report the performance of MenACYW-TT in adolescents 10 through 17 years of age (n = 1504). Results Immune equivalence was demonstrated across all 3 lots of MenACYW-TT conjugate vaccine based on geometric mean titers (GMTs) for all serogroups. Non-inferiority of immune responses, based on percentages of participants achieving hSBA vaccine seroresponse, was demonstrated between MenACYW-TT and MenACWY-D for all four serogroups at Day 30 compared with baseline. The proportions of individuals (10–17 years) with hSBA ≥ 1:8 following MenACYW-TT administration were higher than those after MenACWY-D administration for all four serogroups (A: 96.2% vs. 89.0%; C: 98.5% vs. 74.7%; W: 98.3% vs. 93.7%; Y: 99.1% vs. 94.3%). A similar trend was observed for post vaccination GMTs in adolescent participants. Reactogenicity profiles were comparable across study groups. Most unsolicited adverse events were of grade 1 or grade 2 intensity. No vaccine-related serious adverse events were reported. Conclusion MenACYW-TT vaccine was well tolerated and demonstrated a non-inferior immune response compared with the licensed MenACWY-D vaccine when administered as a single dose to meningococcal vaccine naïve adolescents. Disclosures All authors: No reported disclosures.

PD-L1 inhibition with avelumab plus abiraterone acetate or enzalutamide in African Americans with metastatic castrate-resistant prostate cancer (mCRPC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 87-87
Author(s):  
Jodi Lyn Layton ◽  
Charlotte Manogue ◽  
Malcolm Light ◽  
Ellen Jaeger ◽  
Patrick Cotogno ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
African Americans ◽  
Adverse Events ◽  
Median Time ◽  
The United States ◽  
Abiraterone Acetate ◽  
Phase Iii ◽  
Clinical Progression ◽  
Psa Progression

87 Background: African Americans (AA) are at higher risk for prostate cancer death compared to other ethnic groups in the United States. Early immune-based therapy prolonged overall survival in men with mCRPC and appears to be more pronounced in AA compared to Caucasian men. We sought to explore efficacy of PD-L1 inhibition in AA men with mCRPC. Methods: AA men > 18 years of age and had developed mCRPC on next generation hormonal therapies (NHTs) were eligible for this study. Patients received avelumab 10mg/kg IV every 2 weeks while remaining on NHTs until clinical or radiographic disease progression. This pilot, single-arm phase 2 prospective study was designed to enroll 13 patients with primary endpoint to assess > 50% reduction in PSA (PSA50). Radiographic assessments were planned every 12 weeks until progression or two years, whichever came first. Results: Of the eight patients enrolled, there were three screen-failures: +hepatitis titer (n = 1), rapid clinical deterioration (n = 1) and not confirmed CRPC (n = 1). Median age at time of enrollment was 62 (54-73) with median PSA 7.2 (3.6 – 8.63). Five patients received at least one dose of avelumab and remained on abiraterone acetate with steroid (n = 4) or enzalutamide (n = 1). Median duration on NHTs prior to enrollment was 364 days (95% CI, 260.9-467.1). Median time from screening to cycle 1 was 8 days (3-14). One patient withdrew consent after a single dose of avelumab. Two patients had rapid clinical progression within 8 weeks of starting avelumab. One patient received 9 cycles of avelumab and progressed. One patient experienced a grade 4 adverse event after 2 doses of avelumab with clinical progression during treatment delay. None of the five enrolled patients achieved a PSA50. The median time on study to PSA progression was 35 days (95 CI%, 0-94.8) with median time to radiographic progression of 44 days (95 CI%, 0-118.5). Adverse events occurred in 80% (n = 4/5) of cases. One of the 11 reported grade 3/4 adverse events was related to study drug (G3 hyperglycemia). The study was closed to further accrual prior to the pre-planned completion due to safety concerns related to lack of efficacy of study intervention and rapid clinical progression. Conclusions: The addition of avelumab did not demonstrate clinical activity in AA men with mCRPC who progressed on abiraterone acetate or enzalutamide. The short time interval between PSA progression and radiographic and/or clinical progression is concerning and notable to be much shorter than previously reported pivotal phase III trials. This suggests potential for very significant clinical implications regarding not only future clinical trial designs but also clinical management in this underrepresented ethnicity. We will report updated analysis with longer follow-up (NCT03770455). Clinical trial information: NCT03770455.

scholarly journals Efficacy of afoxolaner in the flea control in experimentally infested cats

2019 ◽  
Vol 28 (4) ◽  
pp. 760-763 ◽  
Author(s):  
Marília Alves Machado ◽  
Diefrey Ribeiro Campos ◽  
Natália Lôres Lopes ◽  
Isabela Pessôa Barbieri Bastos ◽  
Mariana Silva Revoredo Alves ◽  
...  
Keyword(s):  
Single Dose ◽  
Treatment Group ◽  
Adverse Events ◽  
Treated Group ◽  
Ctenocephalides Felis ◽  
Control Group ◽  
Experimental Protocol ◽  
Ctenocephalides Felis Felis ◽  
Flea Control

Abstract The aim of this study was to evaluate the efficacy of a single dose of oral afoxolaner in controlling fleas in cats. Fourteen cats were used. The cats were given identification numbers, housed individually, artificially infested with Ctenocephalides felis felis, and treated (or not) with afoxolaner. Were divided into a treatment group and a control group (n = 7/group), on the basis of the fleas count hours after an infestation applied on Day (one-by-one allocation after ordering by count). At the start of the experimental protocol (designated day 0), the treated group received afoxolaner in a single dose of 2.5 mg/kg and the control group animals received a placebo. All animals were infested with 100 C. felis felis fleas two days before day 0, as well as on days 5, 12, 19, 26, 33, 40, 47, 54, and 63, parasite loads being evaluated at 48 h after each infestation. The efficacy of afoxolaner was 100% on day 2 and remained above 98% until day 42, decreasing to 95.3% by day 63. The findings confirm that a single dose of oral afoxolaner was effective in controlling C. felis felis in cats, and there were no observed adverse events.

657 Interleukin-6 receptor blockade for management of immune checkpoint inhibitor related adverse events in patients with melanoma

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A694-A694
Author(s):  
Chantal Saberian ◽  
Faisal Fa’ak ◽  
Jean Tayar ◽  
Maryam Buni ◽  
Sang Kim ◽  
...  
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Median Time ◽  
Interleukin 6 ◽  
Immune Checkpoint ◽  
Activity Index ◽  
Critical Role ◽  
Cancer Center ◽  
Interleukin 6 Receptor ◽  
Md Anderson

BackgroundManagement of certain immune mediated adverse events (irAEs) can be challenging and may require prolonged/chronic immune suppression with corticosteroids or other immunosuppressant which could compromise and even reverse the efficacy of immune checkpoint inhibitors (ICI). While the exact immunobiology of irAEs is not fully understood there is enough evidence that IL-6 induced Th-17 that may play critical role in the pathogenesis. Herein, we describe our clinical experience using interleukin-6 receptor (IL-6R) blockade in management of irAEs in melanoma patients.MethodsWe searched MD Anderson databases to identify cancer patients who had received ICIs between January 2004 and March 2020. Of 11,391 ICI-treated patients, 21 patients with melanoma who received IL-6R blockade after ICI infusion were identified and their medical records were reviewed.ResultsMedian age was 61 years (41–82), 52% were females, 90% received anti-programmed cell death-1 antibodies. Fourteen patients (67%) had de novo onset irAEs (11 had arthritis, and 1 each with polymyalgia rheumatica, oral mucositis, and CNS vasculitis), and 7 patients (33%) had flare of their pre-existing autoimmune diseases (5 had had rheumatoid arthritis, and 1 each with myasthenia gravis and Crohn’s disease). Median time from ICI initiation to irAEs was 91 days (range, 1–496) and to initiation of IL-6R blockade was 6.6 months (range, 0.6–24.3). Median number of IL-6R blockade was 12 (range, 1–35), and 16 patients (76%) were concomitantly receiving corticosteroids of median dose of 10 mg (range, 5–20 mg). Of the 21 patients, irAEs improved in 14 (67%) (95% CI: 46%-87%). Of 13 evaluable patients with arthritis, 11 (85%) achieved remission or minimal disease activity as defined by the clinical disease activity index. Median time from initiation of IL-6R blockade till improvement of irAEs was 2.9 months (range, 1.5–36.9). Nineteen patients tolerated well IL-6R blockade, while two patients stopped treatment due to abdominal pain and sinus tachycardia. The median CRP levels at irAEs was 84 mg/L (0.6–187) and decreased to 1.9 mg/L (0.56–12) at 10 weeks after initiation of IL-6R blockade (P=0.02). Of the 17 evaluable patients, the overall tumor response rate by RECIST-1.1 criteria was similar before and after IL-6R blockade initiation (41% vs. 53%).ConclusionsOur data demonstrated that IL-6R blockade could be an effective therapy for irAEs management without dampening the efficacy of ICIs. Prospective clinical trials with longitudinal blood, tumor, and inflamed tissue biopsies are planned to accurately validate these findings and better study the immunobiology of irAEs.Ethics ApprovalThe study was approved by The University of Texas MD Anderson Cancer Center intuition’s Ethics Board, approval number PA19-0089

scholarly journals Neurocognitive effects associated with proprotein convertase subtilisin-kexin type 9 inhibitor use: a narrative review

2021 ◽  
Vol 12 ◽  
pp. 204209862095927
Author(s):  
Wei C. Yuet ◽  
Didi Ebert ◽  
Michael Jann
Keyword(s):  
Cognitive Impairment ◽  
Adverse Events ◽  
The United States ◽  
Narrative Review ◽  
Lipid Lowering ◽  
Patient Specific ◽  
Proprotein Convertase ◽  
Pcsk9 Inhibitors ◽  
Pcsk9 Inhibitor ◽  
Receptor Modulation

Neurocognitive adverse events have been observed with the widespread use of 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors or “statins,” which reduce low-density lipoprotein cholesterol (LDL-C) levels and subsequently cardiovascular risk. The United States Food and Drug Association directed manufacturers of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors to monitor for neurocognitive adverse events due to their potent effects on LDL-C reduction, which is a proposed mechanism for neuronal cell dysfunction. Other proposed mechanisms for PCSK9 inhibitor-associated neurocognitive adverse events include N-methyl-d-aspartate receptor modulation, dysregulation of lipid and glucose metabolism, and patient-specific risk factors for cognitive impairment. The purpose of this narrative review article is to describe the proposed mechanisms, incidence of neurocognitive adverse events from phase II and III trials for PCSK9 inhibitors, neurocognitive assessments utilized in clinical trials, and clinical implications. Given the increasing prevalence of PCSK9 inhibitor use and the neurocognitive adverse events observed with prior lipid-lowering therapies, clinicians should be aware of the risks associated with PCSK9 inhibitors, especially when therapy is indicated for patients at high risk for cardiovascular events. Overall, the incidence of PCSK9 inhibitor-associated neurocognitive appears to be uncommon. However, additional prospective studies evaluating cognitive impairment may be beneficial to determine the long-term safety of these agents.

scholarly journals Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Egilius L. H. Spierings ◽  
Mikko Kärppä ◽  
Xiaoping Ning ◽  
Joshua M. Cohen ◽  
Verena Ramirez Campos ◽  
...  
Keyword(s):  
United States ◽  
Czech Republic ◽  
Adverse Events ◽  
Least Squares ◽  
The United States ◽  
Inadequate Response ◽  
Double Blind ◽  
Monthly Average ◽  
Preventive Medication ◽  
Subgroup Analyses

Abstract Background The FOCUS study evaluated the efficacy of migraine preventive medications across different countries within the same patient population, particularly for patients with difficult-to-treat migraine. These prespecified subgroup analyses evaluated efficacy by country in the FOCUS study of fremanezumab in adults with episodic migraine or chronic migraine and documented inadequate response to 2 to 4 migraine preventive medication classes. Methods Overall, 838 participants were enrolled in the FOCUS study, a randomized, double-blind, placebo-controlled, parallel-group, phase 3b study performed at 104 sites. For 12 weeks of double-blind treatment, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched placebo. The primary efficacy endpoint was the mean change from baseline in monthly average migraine days over 12 weeks of double-blind treatment, evaluated by country in these subgroup analyses. Results Of 14 countries contributing data, the Czech Republic (n = 188/838; 22%), the United States (n = 120/838; 14%), and Finland (n = 85/838; 10%) enrolled the most patients. Changes from baseline in monthly average migraine days over 12 weeks were significantly greater with fremanezumab versus placebo for patients in these countries: Czech Republic (least-squares mean difference versus placebo [95% confidence interval]: quarterly fremanezumab, − 1.9 [− 3.25, − 0.47]; P = 0.009; monthly fremanezumab, − 3.0 [− 4.39, − 1.59]; P < 0.001), the United States (quarterly fremanezumab, − 3.7 [− 5.77, − 1.58]; P < 0.001; monthly fremanezumab, − 4.2 [− 6.23, − 2.13]; P < 0.001), and Finland (quarterly fremanezumab, − 3.0 [− 5.32, − 0.63]; P = 0.014; monthly fremanezumab, − 3.9 [− 6.27, − 1.44]; P = 0.002). Results were comparable for the remaining 9 countries, with the least-squares mean difference versus placebo ranging from – 5.6 to – 2.4 with quarterly fremanezumab and from − 5.3 to − 1.5 with monthly fremanezumab. Incidences of serious adverse events and adverse events leading to discontinuation were low and comparable across countries and treatment groups. Conclusions Monthly and quarterly fremanezumab significantly reduced the monthly average number of migraine days versus placebo regardless of country and continent (North America versus Europe) in migraine patients with documented inadequate response to 2 to 4 migraine preventive medication classes. Trial registration ClinicalTrials.gov Identifier: NCT03308968.

scholarly journals Ampicillin-Ceftriaxone vs Ampicillin-Gentamicin for Definitive Therapy of Enterococcus faecalis Infective Endocarditis: A Propensity Score–Matched, Retrospective Cohort Analysis

2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Niyati H Shah ◽  
Kathleen A Shutt ◽  
Yohei Doi
Keyword(s):  
Infective Endocarditis ◽  
Propensity Score ◽  
Adverse Events ◽  
Cohort Analysis ◽  
Hospital Readmissions ◽  
Length Of Hospital Stay ◽  
The United States ◽  
Aminoglycoside Resistance ◽  
Definitive Therapy ◽  
Significant Difference

Abstract Background Ampicillin-ceftriaxone (AC) has emerged as an alternative antibiotic regimen for enterococcal infective endocarditis (EIE) with reduced toxicity compared with ampicillin-gentamicin (AG), but evidence regarding its success in reducing EIE-associated death in the United States is limited. Methods We conducted a retrospective, propensity score–matched cohort analysis of EIE patients treated with AC or AG between 2010 and 2017 at 3 hospitals in Pittsburgh, Pennsylvania. We assessed all-cause 90-day mortality as the primary outcome and in-hospital mortality, length of hospital stay, hospital readmissions, adverse events, and relapse of bacteremia as the secondary outcomes. Results A total of 190 patients with EIE (100 treated with AC and 90 with AG) were included. Ninety-day mortality was significantly higher with AC than AG (21% vs 8%; P = .02). After propensity score matching, 56 patients in each group remained for the outcomes analysis. Documented aminoglycoside resistance, presence of annular or aortic abscess, and complete pacemaker removal were the significantly different variables between the 2 matched cohorts. We observed no statistically significant difference in 90-day mortality between the 2 treatment groups (11% vs 7%; P = .55). Adverse events were more common in patients treated with AG (25 vs 39; P = .0091), and more patients in the propensity score–matched AG cohort switched antibiotic regimens than in the AC group (10% vs 49%; P &lt; .0001). Conclusions Patients treated with AC demonstrate no significant differences in mortality, treatment failure, or bacteremia relapse compared with AG in a propensity score–matched EIE cohort.

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