scholarly journals 1305. Comparison of Pharmacokinetics of DSTA4637S, a novel THIOMABTM Antibody-Antibiotic Conjugate, in Patients with Staphylococcus aureus Bacteremia Receiving Standard-of-Care Antibiotics with Pharmacokinetics in Healthy Volunteers

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S666-S667
Author(s):  
Sharon M Rymut ◽  
Rong Deng ◽  
Ryan Owen ◽  
Ola Saad ◽  
Aklile Berhanu ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Healthy Volunteers ◽  
Clinical Status ◽  
Standard Of Care ◽  
Disease Status ◽  
Double Blind ◽  
Staphylococcus Aureus Bacteremia ◽  
Dose Study ◽  
Phase 1B ◽  
Favorable Safety

Abstract Background DSTA4637S, a THIOMABTM antibody-antibiotic conjugate against Staphylococcus aureus, is a potential therapy for complicated S. aureus bacteremia. Single doses showed favorable safety and pharmacokinetics (PK) in healthy volunteers (HVs). This study compares HV PK results to PK from a Phase 1b study evaluating multiple doses in patients with bacteremia. Methods In a Phase 1a study, HVs received single intravenous (IV) doses (5, 15, 50, 100, or 150 mg/kg) of DSTA4637S. The Phase 1b, randomized, double-blind, placebo-controlled, multiple ascending-dose study enrolled patients with MRSA or MSSA bacteremia receiving ≥ 4 weeks of standard-of-care (SOC) antibiotics in combination with IV DSTA4637S (15, 45, or 100 mg/kg) weekly (4-6 doses). Intensive PK serum and plasma sampling was performed after first and last doses of DSTA4637S. Total antibody (TAb) was measured in serum by ELISA. DSTA4637S conjugate (ac-dmDNA31) and unconjugated dmDNA31 were measured in plasma with IA-LC-MS/MS and LC-MS/MS, respectively. DSTA4637S PK was analyzed using a non-compartmental approach using WinNonlin. Results DSTA4637S PK data were evaluated in 20 HVs in the Phase 1a study and 19 patients with S. aureus bacteremia in the Phase 1b study. In both HVs and patients, systemic exposures of TAb and ac-dmDNA were generally dose proportional over the dose ranges tested. In patients compared to HVs, Cmax, cycle 1 for ac-dmDNA31 and TAb were reduced 26.7-51.3% and 32.4-44.1%, respectively, contributing to lower patient AUC0-7. Unconjugated dmDNA31 concentrations were low (< 11 ng/mL), peaking 1-2 days after dosing, in both studies. There was no clear association between DSTA4637S exposure (ac-dmDNA31) and demographic factors (age, weight, sex), clinical status (bacteremia at dosing, infection site), adverse events (infusion-related reactions), or exploratory biomarkers (CRP, procalcitonin, inflammatory cytokines). Conclusion DSTA4637S PK analysis demonstrated lower exposures in patients with S. aureus bacteremia compared to HVs. Potential explanations for reduced exposures include factors related to disease status, non-specific organ uptake, and target-mediated clearance. Disclosures Sharon M. Rymut, PhD, Genentech (Employee, Shareholder) Rong Deng, PhD, Roche (Consultant, Employee, Shareholder) Ryan Owen, PhD, Genentech (Employee, Shareholder) Ola Saad, PhD, Genentech - Roche (Employee) Aklile Berhanu, PhD, Genentech, Inc. (Employee, Equity interest (Stock/Stock Options)) Jeremy Lim, PharmD, Roche (Employee, Shareholder) Montserrat Carrasco-Triguero, PhD, Genentech (Employee) Jessica A. Couch, PhD, Genentech (Employee, Shareholder) Melicent C. Peck, MD, PhD, Genentech (Employee)

scholarly journals 167. A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple-ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Patients with staphylococcus Aureus Bacteremia Receiving Standard-of-care Antibiotics

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S213-S213
Author(s):  
Jeremy Lim ◽  
Nicholas Lewin-Koh ◽  
Tom Chu ◽  
Sharon M Rymut ◽  
Aklile Berhanu ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Healthy Volunteers ◽  
Study Drug ◽  
Standard Of Care ◽  
Research Support ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Staphylococcus Aureus Bacteremia ◽  
Phase 1B ◽  
Research Grant

Abstract Background New treatment approaches for complicated Staphylococcus aureus bacteremia (SAB) are needed. DSTA4637S is a THIOMABTM antibody-antibiotic conjugate consisting of an engineered human IgG1 monoclonal antibody that binds to wall teichoic acid at the surface of S. aureus, a protease-cleavable linker, and a novel rifamycin class antibiotic, dmDNA31. This Phase 1b study assessed the safety, tolerability, and pharmacokinetics of DSTA4637S in patients with complicated SAB. Methods Multicenter, double-blind, placebo controlled, multiple-ascending dose clinical trial. Patients 18–79 years old with complicated SAB requiring at least 4 weeks of IV anti-staphylococcal standard-of-care (SOC) antibiotics were randomized to receive 4–6 doses of 15, 45, and 100 mg/kg IV DSTA4637S or placebo (6 active:2 placebo) every 7 days in combination with SOC antibiotics. Patients needed ≥ 1 blood culture positive for S. aureus collected within 120 hours prior to randomization. Patients were followed for 120 days after the end of treatment. Results Twenty-five patients with complicated SAB (bone & joint, n=14; endocarditis, n=5; other endovascular, n=5; pneumonia, n=1) were randomized and received 1–6 doses of study drug (19 active:6 placebo). Nine patients (36%) had MRSA. Ten patients completed ≥4 doses of DSTA4637S. The most common treatment-related adverse events were infusion-related reactions (IRRs) (5/19), and abnormal serum color (5/19)/skin discoloration (3/19 (due to dmDNA31). IRRs were not dose-dependent and were reversible with supportive care. Ten of 19 patients (40%) discontinued study drug (9 DSTA4637S,1 placebo); 4/19 (21%) due to IRR. DSTA4637S recipients showed no dose-related changes in laboratory values or vital signs vs. placebo. Observed exposures (Cmax and AUC) were lower in patients immediately after dosing compared to a prior study in healthy volunteers; minimal accumulation occurred. No obvious trends in exploratory bacterial and inflammatory biomarkers were observed between treatment groups. Conclusion DSTA4637S in patients with complicated SAB demonstrated increased IRRs and decreased exposure compared to healthy volunteers, highlighting the importance of Phase I studies of novel treatments in infected SAB patients and not simply healthy controls. Disclosures Jeremy Lim, PharmD, Roche (Employee, Shareholder) Nicholas Lewin-Koh, PhD, Genentech (Employee) Tom Chu, MD, PhD, Genentech (Employee) Sharon M. Rymut, PhD, Genentech (Employee, Shareholder) Aklile Berhanu, PhD, Genentech, Inc. (Employee, Equity interest (Stock/Stock Options)) Montserrat Carrasco-Triguero, PhD, Genentech (Employee) Carrie C. Rosenberger, PhD, Genentech (Employee, Shareholder) Wouter L. Hazenbos, PhD, Genentech (Employee) Loren G. Miller, MD, MPH, genentech (Grant/Research Support) Vance G. Fowler, Jr., MD, MHS, Achaogen (Consultant)Actavis (Grant/Research Support)Advanced Liquid Logics (Grant/Research Support)Affinergy (Consultant, Research Grant or Support)Affinium (Consultant)Allergan (Grant/Research Support)Ampliphi Biosciences (Consultant)Basilea (Consultant, Research Grant or Support)Bayer (Consultant)C3J (Consultant)Cerexa (Consultant, Research Grant or Support)Contrafect (Consultant, Research Grant or Support)Cubist (Grant/Research Support)Debiopharm (Consultant)Destiny (Consultant)Durata (Consultant)Forest (Grant/Research Support)Genentech (Consultant, Research Grant or Support)Integrated Biotherapeutics (Consultant)Janssen (Consultant, Research Grant or Support)Karius (Grant/Research Support)Locus (Grant/Research Support)Medical Biosurfaces (Grant/Research Support)Medicines Co. (Consultant)Medimmune (Consultant, Research Grant or Support)Merck (Consultant, Research Grant or Support)NIH (Grant/Research Support)Novadigm (Consultant)Novartis (Consultant, Research Grant or Support)Pfizer (Grant/Research Support)Regeneron (Consultant, Research Grant or Support)Tetraphase (Consultant)Theravance (Consultant, Research Grant or Support)Trius (Consultant)xBiotech (Consultant) Jose M Miro, MD PhD, GENENTECH (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member) Jessica A. Couch, PhD, Genentech (Employee, Shareholder) Melicent C. Peck, MD, PhD, Genentech (Employee)

scholarly journals LB12. Exebacase Shows Rapid Symptom Resolution in a Phase 2 Study in Adult Patients with Staphylococcus aureus bacteremia

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S811-S811
Author(s):  
Cara Cassino ◽  
Anita F Das ◽  
Joy Lipka
Keyword(s):  
Staphylococcus Aureus ◽  
Infective Endocarditis ◽  
Therapeutic Potential ◽  
Length Of Hospital Stay ◽  
Standard Of Care ◽  
Phase 2 ◽  
Double Blind ◽  
Symptom Resolution ◽  
Staphylococcus Aureus Bacteremia ◽  
Phase 2 Trial

Abstract Background Exebacase (EXB), a recombinantly-produced lysin (cell wall hydrolase), is the first direct lytic agent to advance into Phase 3 of clinical development for the treatment of bacteremia including infective endocarditis due to Staphylococcus aureus. The microbiologic attributes of EXB, including pathogen-targeted rapid bacteriolysis, and biofilm eradication are distinct from and synergistic with those of traditional antibiotics and underpin the therapeutic potential for EXB. Methods The Phase 2 trial was a randomized, double-blind, placebo-controlled multinational study. Patients were randomized (2:1) to receive a single 2-hour infusion of EXB or placebo (PBO) in addition to standard of care antibiotics. Time to resolution of symptoms (shortness of breath, sweating, fatigue and confusion) attributable to the bacteremia was analyzed using Kaplan-Meier methods. Time to resolution was defined as the number of days until all attributable symptoms were absent. If a new (not present at baseline) attributable symptom was present before the baseline symptoms resolved, this new symptom also had to be absent for symptoms to be considered resolved. Results A total of 86 patients (53 EXB and 33 PBO) had at least one attributable symptom present at baseline. Of these, symptoms resolved in 94.3% and 87.9% of EXB and PBO patients, respectively. The median time to resolution was 3 days for EXB and 6 days for PBO patients. Median days to symptom resolution in the MRSA group was 3 and 7 days for EXB and PBO patients, respectively, and 3 and 5 days for EXB and PBO patients in the MSSA group, respectively. Time to symptom resolution in MRSA patients in presented in Figure 1. Figure 1. Time to Resolution of Symptoms in Patients with MRSA Bacteremia including Infective Endocarditis Conclusion The majority of EXB and PBO patients had symptom resolution. However, EXE patients achieved symptom resolution in 3 days compared with 6 days for PBO patients overall, and 7 days for PBO patients with MRSA. These data suggest that rapid bacteriolysis may translate to a clinical benefit for patients receiving EXB and aligns with a median length of hospital stay of 6 and 10 days among US MRSA patients that received EXE and PBO patients, respectively. (Fowler, et al, 2020). Disclosures Cara Cassino, MD, ContraFect Corporation (Employee) Anita F. Das, PhD, Adagio (Consultant)AN2 (Consultant)Cidara (Consultant)ContraFect (Consultant)Iterum (Consultant)MicuRx (Consultant)Paratek (Consultant)Union (Consultant) Joy Lipka, MS, ContraFect Corporation (Consultant)

Safety and pharmacokinetics of recombinant factor XIII in healthy volunteers. A randomized, placebo-controlled, double-blind, multi-dose study

2005 ◽  
Author(s):  
Jennifer E. Visich ◽  
Linda A. Zuckerman ◽  
Michael D. Butine ◽  
Kulasiri A. Gunewardena ◽  
Richard Wild ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Factor Xiii ◽  
Double Blind ◽  
Dose Study

scholarly journals Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study of the Penetration of a Monoclonal Antibody Combination (ASN100) Targeting Staphylococcus aureus Cytotoxins in the Lung Epithelial Lining Fluid of Healthy Volunteers

2019 ◽  
Vol 63 (8) ◽  
Author(s):  
Zoltan Magyarics ◽  
Fraser Leslie ◽  
Johann Bartko ◽  
Harald Rouha ◽  
Steven Luperchio ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Adverse Events ◽  
Healthy Volunteers ◽  
Dose Escalation ◽  
Human Study ◽  
Epithelial Lining ◽  
Open Label ◽  
Double Blind ◽  
Epithelial Lining Fluid ◽  
Double Blind Placebo

ABSTRACT ASN100 is a novel antibody combination of two fully human IgG1(κ) monoclonal antibodies (MAbs), ASN-1 and ASN-2, which neutralize six Staphylococcus aureus cytotoxins, alpha-hemolysin (Hla) and five bicomponent leukocidins. We assessed the safety, tolerability, and serum and lung pharmacokinetics of ASN100 in a randomized, double-blind, placebo-controlled single-dose-escalation first-in-human study. Fifty-two healthy volunteers were enrolled and randomized to receive either ASN-1, ASN-2, a combination of both MAbs (ASN100), or a corresponding placebo. Thirty-two subjects in the double-blind dose escalation portion of the study received ASN-1 or ASN-2 at a 200-, 600-, 1,800-, or 4,000-mg dose, or placebo. Eight subjects received both MAbs simultaneously in a 1:1 ratio (ASN100) at 3,600 or 8,000 mg, or they received placebos. Twelve additional subjects received open-label ASN100 at 3,600 or 8,000 mg to assess the pharmacokinetics of ASN-1 and ASN-2 in epithelial lining fluid (ELF) by bronchoalveolar lavage fluid sampling. Subjects were monitored for 98 days (double-blind cohorts) or 30 days (open-label cohorts) for safety assessment. No dose-limiting toxicities were observed, and all adverse events were mild and transient, with only two adverse events considered possibly related to the investigational product. ASN100 exhibited linear serum pharmacokinetics with a half-life of approximately 3 weeks and showed detectable penetration into the ELF. No treatment-emergent anti-drug antibody responses were detected. The toxin neutralizing potency of ASN100 in human serum was confirmed up to 58 days postdosing. The favorable safety profile, ELF penetration, and maintained functional activity in serum supported the further clinical development of ASN100.

A Subcutaneously Administered Investigational RNAi Therapeutic (ALN-CC5) Targeting Complement C5 for Treatment of PNH and Complement-Mediated Diseases: Interim Phase 1 Study Results

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2413-2413 ◽  
Author(s):  
Anita Hill ◽  
Jorg Taubel ◽  
Jim Bush ◽  
Anna Borodovsky ◽  
Noriyuki Kawahata ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Phase 1 ◽  
Employment Equity ◽  
Double Blind ◽  
Therapeutic Targeting ◽  
Primary Endpoints ◽  
Study Results ◽  
Tolerability Data ◽  
Dose Study ◽  
Equity Ownership

Abstract Introduction: Uncontrolled complement activation plays a pivotal role in a variety of disorders such as PNH and aHUS. ALN-CC5 is a subcutaneous (SC) investigational RNAi therapeutic targeting complement C5 (C5). In preclinical studies, ALN-CC5 has demonstrated decreased terminal complement activity. Based on the literature, preventing the generation of the terminal complex protects against intravascular hemolysis and complement-mediated tissue damage. The purpose of this study is to evaluate the safety and tolerability of ALN-CC5 in normal healthy volunteers. Material and methods: A multi-centered, placebo controlled, double blind phase 1 clinical study in healthy volunteers is ongoing. Several cohorts of healthy volunteers in Part A, a single ascending dose study and Part B, a weekly multiple ascending dose study have been completed. Primary endpoints are safety and tolerability. Secondary endpoints are pharmacokinetics, reduction of circulating C5, reduction in hemolytic, CAP and CCP activity. Results: In Part A, 20 healthy volunteers were randomized (1:3) to placebo or single SC dose of 50, 200, 400, 600 or 900mg of ALN-CC5 and followed for at least 70 days. In Part B, 12 healthy volunteers were randomized (1:3) to placebo or 5 weekly doses of 100, 200 or 400mg of ALN-CC5. No SAEs or study discontinuations occurred and overall ALN-CC5 was considered safe and generally well tolerated. A dose dependent and 94% mean maximum C5 knockdown was achieved following weekly administration. Updated safety and tolerability data as well as C5 knockdown, and changes in CAP, CCP and hemolytic activity from the study will be presented. Conclusion: Collectively, these initial results suggest that the use of a novel RNAi therapeutic targeting C5 is a promising approach for inhibiting complement in PNH, aHUS and other complement-mediated diseases. The subcutaneous route of administration and infrequent dosing make this a potentially encouraging therapy. Disclosures Hill: Alnylam: Consultancy. Off Label Use: ALN-CC5 is an investigational RNAi therapeutic targeting complement C5.. Borodovsky:Alnylam Pharmaceuticals: Employment, Equity Ownership. Kawahata:Alnylam Pharmaceuticals: Employment, Equity Ownership. Mclean:Alnylam Pharmaceuticals: Employment, Equity Ownership. Powell:Alnylam Pharmaceuticals: Employment, Equity Ownership. Chaturvedi:Alnylam Pharmaceuticals: Employment, Equity Ownership. Warner:Alnylam Pharmaceuticals: Employment, Equity Ownership. Garg:Alnylam Pharmaceuticals: Employment, Equity Ownership. Sorensen:Alnylam Pharmaceuticals: Employment, Equity Ownership.

Radium-223 chloride impact on skeletal-related events in patients with castration-resistant prostate cancer (CRPC) with bone metastases: A phase III randomized trial (ALSYMPCA).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 9-9 ◽  
Author(s):  
A. Oliver Sartor ◽  
Daniel Heinrich ◽  
Svein Inge Helle ◽  
Joe M. O'Sullivan ◽  
Sophie D. Fossa ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Standard Of Care ◽  
High Energy ◽  
Alpha Particles ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
Radium 223 ◽  
Skeletal Related Events ◽  
Favorable Safety

9 Background: Radium-223 chloride (Ra-223) is a 1st-in-class alpha-pharmaceutical targeting bone metastases (mets) with high-energy alpha-particles of short range (<100 μm). ALSYMPCA, a phase III, double-blind, randomized, multinational study, compared Ra-223 plus best standard of care (BSC) vs placebo (pbo) plus BSC in patients (pts) with bone mets in CRPC. The primary endpoint was OS; secondary endpoints included skeletal-related events (SREs). Methods: Eligible pts had progressive, symptomatic CRPC with ≥ 2 bone mets on scintigraphy and no known visceral mets; were receiving BSC; and either previously received docetaxel, were docetaxel ineligible, or refused docetaxel. Pts were randomized 2:1 to receive 6 injections of Ra‐223 (50 kBq/kg IV) q4 wks or matching pbo and stratified by prior docetaxel use, baseline alkaline phosphatase level, and current bisphosphonate use. Results: 922 pts (Ra-223, n = 615; pbo, n = 307) were randomized from 6/2008-2/2011. Based on data from a planned interim analysis (n = 809), unblinded June 2011, Ra-223 significantly improved OS in pts with CRPC with bone mets vs pbo (median OS 14.0 vs 11.2 mo, respectively; two-sided P = 0.00185; HR = 0.695; 95% CI, 0.552-0.875). SREs were lower in the Ra-223 vs pbo group, and time to 1st SRE was significantly delayed (median time to SRE 13.6 mo vs 8.4 mo, respectively; P = .00046; HR = .610; 95% CI, .461-.807). Conclusions: Ra-223 significantly delayed time to 1st SRE and SRE components, except surgical intervention. These reductions in SREs, particularly SCC, are noteworthy. Ra-223 is an effective therapy with a highly favorable safety profile and may provide a new standard of care for treatment of CRPC pts with bone mets. [Table: see text]

scholarly journals Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia

2022 ◽  
Vol 13 (1) ◽  
Author(s):  
Earl Sands ◽  
Alan Kivitz ◽  
Wesley DeHaan ◽  
Sheldon S. Leung ◽  
Lloyd Johnston ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Standard Of Care ◽  
Secondary Endpoint ◽  
Dependent Manner ◽  
Open Label ◽  
Biologic Drugs ◽  
Double Blind ◽  
Open Label Study ◽  
Phase 1B ◽  
Dose Dependent

AbstractBiologic drugs have transformed the standard of care for many diseases. However, many biologics induce the formation of anti-drug antibodies (ADAs), which can compromise their safety and efficacy. Preclinical studies demonstrate that biodegradable nanoparticles-encapsulating rapamycin (ImmTOR), but not free rapamycin, mitigate the immunogenicity of co-administered biologic drugs. Here we report the outcomes from two clinical trials for ImmTOR. In the first ascending dose, open-label study (NCT02464605), pegadricase, an immunogenic, pegylated uricase enzyme derived from Candida utilis, is assessed for safety and tolerability (primary endpoint) as well as activity and immunogenicity (secondary endpoint); in the second single ascending dose Phase 1b trial (NCT02648269) composed of both a double-blind and open-label parts, we evaluate the safety of ImmTOR (primary endpoint) and its ability to prevent the formation of anti-drug antibodies against pegadricase and enhance its pharmacodynamic activity (secondary endpoint) in patients with hyperuricemia. The combination of ImmTOR and pegadricase is well tolerated. ImmTOR inhibits the development of uricase-specific ADAs in a dose-dependent manner, thus enabling sustained enzyme activity and reduction in serum uric acid levels. ImmTOR may thus represent a feasible approach for preventing the formation of ADAs to a broad range of immunogenic biologic therapies.

scholarly journals 117. Adjunctive Daptomycin in the Treatment of staphylococcus Aureus Bacteremia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S187-S187
Author(s):  
Matthew P Cheng ◽  
Alexander Lawandi ◽  
Guillaume Butler-Laporte ◽  
Samuel De L’Etoile-Morel ◽  
Katryn Paquette ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Median Duration ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Absolute Difference ◽  
Double Blind ◽  
Intention To Treat ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Treat Analysis

Abstract Background Bloodstream infections (BSI) caused by methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine whether daptomycin given in combination with an anti-staphylococcal beta-lactam improved outcomes in MSSA BSI. Methods A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days. Results Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0). There were no significant differences in the proportion of patients who developed renal failure, hepatotoxicity, or rhabdomyolysis between groups. Conclusion Among patients with MSSA BSI, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia. Disclosures All Authors: No reported disclosures

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