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daptomycin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Cross-References

ID SourceID
PubMed CID117590581
MeSH IDM0026638

Synonyms (4)

Synonym
daptomycin ,
103060-53-3
AKOS025401343
AC-1162

Research Excerpts

Toxicity

Previous reports on daptomycin's adverse drug reactions (ADRs) have been insufficient, often because of limited data. Concomitant administration of daptmycin and statins is safe and is not associated with an increased risk of rhabdomyolysis.

ExcerptReferenceRelevance
" We conclude that daptomycin is safe and protects kidney cells from tobramycin-induced nephrotoxicity."( Effects of daptomycin and vancomycin on tobramycin nephrotoxicity in rats.
Beauchamp, D; Bergeron, MG; Gourde, P; Pellerin, M; Pettigrew, M, 1990
)
0.28
" Safety and tolerability were evaluated by monitoring adverse events (AEs) and laboratory parameters."( Daptomycin pharmacokinetics and safety following administration of escalating doses once daily to healthy subjects.
Arbeit, RD; Brazier, D; DeBruin, MF; Dvorchik, BH, 2003
)
0.32
" The frequency and distribution of adverse events were similar among both treatment groups."( The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections.
Arbeit, RD; Campanaro, E; Eisenstein, BI; Maki, D; Tally, FP, 2004
)
0.32
" Daptomycin was well tolerated, with most adverse events considered to be unrelated to study medication, of mild-to-moderate intensity, and with a frequency and distribution similar to those associated with comparator antibiotics."( The efficacy and safety of daptomycin: first in a new class of antibiotics for Gram-positive bacteria.
Rybak, MJ, 2006
)
0.33
"Although daptomycin is a well-tolerated antibacterial agent, clinicians should consider periodic monitoring of liver function and renal function tests to identify potential adverse effects."( Daptomycin-induced acute renal and hepatic toxicity without rhabdomyolysis.
Abraham, G; Finkelberg, D; Spooner, LM, 2008
)
0.35
" No serious adverse events (AE) or deaths occurred during the study."( Pharmacokinetics and safety of multiple intravenous doses of daptomycin in a Taiwanese adult population.
Chang, SC; Huang, YT; Liang, SH; Sheng, WH; Wu, FL, 2009
)
0.35
" Daptomycin 4 mg/kg once daily appeared to be effective and safe for treating cellulitis or erysipelas."( The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas.
Bernardo, P; Biermann, EJ; Donfrid, B; Eisenstein, BI; Link, AS; Martone, WJ; Pertel, PE, 2009
)
0.35
" In both studies, daptomycin was well tolerated and the majority of treatment-emergent adverse events were of mild intensity and considered to be unrelated to daptomycin."( Comparison of the pharmacokinetics, safety and tolerability of daptomycin in healthy adult volunteers following intravenous administration by 30 min infusion or 2 min injection.
Chakraborty, A; Chaves, RL; Loeffler, J; Roy, S, 2009
)
0.35
" Grade 1 adverse events occurred in 22 patients and did not lead to daptomycin discontinuation."( Safety of high-dose intravenous daptomycin treatment: three-year cumulative experience in a clinical program.
Amodio-Groton, M; Fana, C; Figueroa, DA; Mangini, E; Melchert, A; Segal-Maurer, S; Urban, CM; Vardianos, B; Wehbeh, W, 2009
)
0.35
"4%) of the 94 patients experienced 1 or more adverse events or abnormal laboratory value changes possibly related to daptomycin; in 2 (2."( Safety and clinical outcomes when utilizing high-dose (> or =8 mg/kg) daptomycin therapy.
Amodio-Groton, MI; Hershberger, E; Lamp, KC; Moise, PA, 2009
)
0.35
" Thirty-one (10%) patients experienced adverse events possibly related to daptomycin and the incidence was similar regardless of dose."( Safety and efficacy of daptomycin in the treatment of osteomyelitis: results from the CORE Registry.
Crompton, JA; Lamp, KC; McConnell, SA; North, DS, 2009
)
0.35
" The daptomycin group was comparable with the vancomycin group in terms of neutropenia rate, complications, adverse events, length of hospital stay and death."( Efficacy and safety of daptomycin in the treatment of Gram-positive catheter-related bloodstream infections in cancer patients.
Adachi, J; Chaftari, AM; Chemaly, RF; Hachem, R; Jacobson, K; Jiang, Y; Mulanovich, V; Raad, I, 2010
)
0.36
" Pharmacokinetic parameters were described, and adverse events were monitored."( Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis.
Benziger, DP; Cannon, C; Donovan, J; Pertel, PE; Schwab, RJ; Swan, SK; Yankelev, S, 2011
)
0.37
" Adverse events were experienced by 71."( Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis.
Benziger, DP; Cannon, C; Donovan, J; Pertel, PE; Schwab, RJ; Swan, SK; Yankelev, S, 2011
)
0.37
"A dose of 200 μg of intravitreal daptomycin appears to be safe and efficacious in a rabbit model of bacterial endophthalmitis."( Intravitreal daptomycin: a safety and efficacy study.
Comer, GM; Elner, VM; Khan, NW; Miller, JB; Reed, DM; Schneider, EW; Zacks, DN, 2011
)
0.37
" Thirty-eight adverse events possibly related to daptomycin occurred in 28 patients (7%); increased blood creatine kinase level (7 patients [1."( Safety of daptomycin in patients receiving hemodialysis.
Crompton, JA; Donovan, BJ; Lamp, KC; Mueller, BA; Yankalev, S, 2011
)
0.37
" Adverse effects related to daptomycin were detected in nine patients, but none were required to discontinue daptomycin."( Safety and efficacy of daptomycin for the treatment of hospitalized adult patients in Taiwan with severe staphylococcal infections.
Chang, SC; Chen, CJ; Chen, DL; Chou, MU; Ho, MW; Lai, CC; Lee, CM; Liao, CH; Lin, YC; Pong, MY; Sheng, WH; Wang, JT, 2012
)
0.38
"The results support daptomycin as an effective and safe treatment for staphylococcal infections in Taiwanese populations."( Safety and efficacy of daptomycin for the treatment of hospitalized adult patients in Taiwan with severe staphylococcal infections.
Chang, SC; Chen, CJ; Chen, DL; Chou, MU; Ho, MW; Lai, CC; Lee, CM; Liao, CH; Lin, YC; Pong, MY; Sheng, WH; Wang, JT, 2012
)
0.38
" Based on our data, concomitant administration of daptomycin and statins is safe and is not associated with an increased risk of rhabdomyolysis."( Safety analysis of high dose (>6 mg/kg/day) daptomycin in patients with concomitant statin therapy.
Dueñas-Gutiérrez, C; Garrido-Gomez, J; Hernández-Quero, J; Linares-Palomino, JP; Parra-Ruiz, J; Tomás-Jiménez, C, 2012
)
0.38
"The objective of this study was to analyse adverse event (AE) reports submitted to the US FDA as well as published cases to characterize the clinical features and course of EP in daptomycin-treated patients."( Eosinophilic pneumonia in patients treated with daptomycin: review of the literature and US FDA adverse event reporting system reports.
Kim, PW; Nambiar, S; Pham, TM; Sorbello, AF; Tonning, JM; Wassel, RT, 2012
)
0.38
"We searched for EP cases associated with daptomycin administration in the FDA Adverse Event Reporting System (AERS) submitted from 2004 to 2010, and the published literature."( Eosinophilic pneumonia in patients treated with daptomycin: review of the literature and US FDA adverse event reporting system reports.
Kim, PW; Nambiar, S; Pham, TM; Sorbello, AF; Tonning, JM; Wassel, RT, 2012
)
0.38
" In conclusion, daptomycin at 6 and 8 mg/kg given for up to 6 weeks was safe and appeared to be effective in managing staphylococcal PJI using a 2-stage revision arthroplasty technique in a total of 49 patients."( Randomized controlled trial of the safety and efficacy of Daptomycin versus standard-of-care therapy for management of patients with osteomyelitis associated with prosthetic devices undergoing two-stage revision arthroplasty.
Anastasiou, D; Byren, I; Campanaro, E; Evans, R; Kuropatkin, G; Rege, S; Yankelev, S, 2012
)
0.38
" Daptomycin was generally well tolerated; most adverse events were of mild to moderate severity."( Efficacy and safety of intravenous daptomycin in Japanese patients with skin and soft tissue infections.
Aikawa, N; Kato, Y; Kusachi, S; Mikamo, H; Morita, A; Takesue, Y; Tanaka, Y; Tsumori, K; Watanabe, S; Yoshinari, T, 2013
)
0.39
" Adverse effects of daptomycin were generally well-tolerated, leading to discontinuation in 3 patients."( Safety and efficacy of high-dose daptomycin as salvage therapy for severe gram-positive bacterial sepsis in hospitalized adult patients.
Chang, SC; Chen, YC; Cheng, A; Chuang, YC; Lai, CC; Sheng, WH; Wang, JT, 2013
)
0.39
"Treatment with high dose daptomycin as salvage therapy was generally effective and safe in Taiwan."( Safety and efficacy of high-dose daptomycin as salvage therapy for severe gram-positive bacterial sepsis in hospitalized adult patients.
Chang, SC; Chen, YC; Cheng, A; Chuang, YC; Lai, CC; Sheng, WH; Wang, JT, 2013
)
0.39
" Investigators assessed adverse events (AEs) using ICH-E2A definitions of seriousness/severity ≤30 days after completing daptomycin."( Safety of daptomycin in patients completing more than 14 days of therapy: results from the Cubicin® Outcomes Registry and experience.
Lamp, KC; Lindfield, KC; Mohr, J; Rege, S; Yoon, M, 2013
)
0.39
" Adverse events regardless of relationship to study drug were reported for 11% of patients with cSSTIs and 24% with bacteraemia, most commonly septic shock [7 patients (2%) with cSSTIs and 5 patients (2%) with bacteraemia]."( Effectiveness and safety of daptomycin in complicated skin and soft-tissue infections and bacteraemia in clinical practice: results of a large non-interventional study.
Beiras-Fernandez, A; Chaves, RL; Dohmen, PM; Gonzalez-Ruiz, A; Lehmkuhl, H; Loeffler, J, 2013
)
0.39
"Primary safety outcomes included incidence of creatine phosphokinase (CPK) elevations more than 1000 units/L, more than 500 units/L, myalgias, and discontinuation of therapy due to adverse drug events (ADEs)."( Safety and effectiveness of daptomycin across a hospitalized obese population: results of a multicenter investigation in the southeastern United States.
Bland, CM; Bookstaver, PB; Caulder, CR; Faulkner-Fennell, CM; Hartis, C; Qureshi, ZP; Sheldon, MA, 2013
)
0.39
" Rates of adverse events (AEs) and serious AEs were similar in both treatment arms; however, discontinuation rates for AEs/serious AEs were lower for daptomycin than for the comparator (3."( Safety and efficacy of daptomycin as first-line treatment for complicated skin and soft tissue infections in elderly patients: an open-label, multicentre, randomized phase IIIb trial.
Bouylout, K; Chaves, RL; Fierlbeck, G; Heep, M; Konychev, A; Kreuter, A; Moritz, RK; Pathan, R; Shulutko, A; Trostmann, U, 2013
)
0.39
" The purpose of this study was to compare antimicrobial adverse event rates and associated healthcare interventions and healthcare utilization in patients treated with the two antimicrobials."( Adverse events, healthcare interventions and healthcare utilization during home infusion therapy with daptomycin and vancomycin: a propensity score-matched cohort study.
Gordon, SM; Mason, P; Neuner, E; Nutter, B; O'Rourke, C; Rehm, SJ; Shrestha, NK, 2014
)
0.4
" Adverse event, healthcare intervention and healthcare utilization rates during OPAT were compared in the matched cohort using negative binomial regression models."( Adverse events, healthcare interventions and healthcare utilization during home infusion therapy with daptomycin and vancomycin: a propensity score-matched cohort study.
Gordon, SM; Mason, P; Neuner, E; Nutter, B; O'Rourke, C; Rehm, SJ; Shrestha, NK, 2014
)
0.4
"Patients receiving daptomycin at home have 60% fewer antimicrobial adverse events and require 80% fewer antimicrobial interventions than similar patients receiving vancomycin."( Adverse events, healthcare interventions and healthcare utilization during home infusion therapy with daptomycin and vancomycin: a propensity score-matched cohort study.
Gordon, SM; Mason, P; Neuner, E; Nutter, B; O'Rourke, C; Rehm, SJ; Shrestha, NK, 2014
)
0.4
" No patient required discontinuation of daptomycin because of adverse effects."( Daptomycin is safe and effective for the treatment of gram-positive cocci infections in solid organ transplantation.
Azanza, JR; Cervera, C; Cordero, E; Fariñas, MC; Gavaldà, J; Len, O; Martín-Dávila, P; Montejo, M; Pahissa, A; Ramos, A; Sabé, N; Torre-Cisneros, J, 2014
)
0.4
"In summary, daptomycin was a safe and useful treatment for GPC infection in SOT recipients."( Daptomycin is safe and effective for the treatment of gram-positive cocci infections in solid organ transplantation.
Azanza, JR; Cervera, C; Cordero, E; Fariñas, MC; Gavaldà, J; Len, O; Martín-Dávila, P; Montejo, M; Pahissa, A; Ramos, A; Sabé, N; Torre-Cisneros, J, 2014
)
0.4
" However, daptomycin tended to have a similar treatment-related adverse events (AEs) incidence in comparison with other antibiotics (OR=1."( The safety and efficacy of daptomycin versus other antibiotics for skin and soft-tissue infections: a meta-analysis of randomised controlled trials.
Chen, XF; Hu, JT; Jiang, LY; Tang, ZH; Wang, SZ; Zhang, C; Zhou, W, 2014
)
0.4
" Fewer adverse effects in total, but more CPK elevation effects, were observed in patients treated with daptomycin."( Efficacy and safety of daptomycin for the treatment of infectious disease: a meta-analysis based on randomized controlled trials.
Chen, H; He, W; Wang, H; Zhang, Y; Zhao, C, 2014
)
0.4
" In these situations, daptomycin is a safe and effective alternative."( Daptomycin in the treatment of prosthetic joint infection by Enterococcus faecalis: safety and efficacy of high-dose and prolonged therapy.
Del Pozo, JL; Díaz-Rada, P; Quesada, M; Yuste, JR, 2014
)
0.4
"4%) represented drug-related adverse effect, but no serious adverse effect was reported."( [The efficacy and safety of daptomycin for the treatment of Gram-positive bacterial infections in Chinese population].
Gao, H; Li, J; Liu, H; Liu, Z; Shen, J; Wan, X; Wang, A; Zhang, L, 2015
)
0.42
"Daptomycin is effective and safe for Chinese patients with serious infections of Gram-positive cocci."( [The efficacy and safety of daptomycin for the treatment of Gram-positive bacterial infections in Chinese population].
Gao, H; Li, J; Liu, H; Liu, Z; Shen, J; Wan, X; Wang, A; Zhang, L, 2015
)
0.42
" The incidence, timing, severity and evolution of adverse events (AEs) were assessed."( Safety of treatment with high-dose daptomycin in 102 patients with infective endocarditis.
Andini, R; Caprioli, R; Cavezza, G; Diana, MV; Durante-Mangoni, E; Mattucci, I; Parrella, A; Senese, A; Trojaniello, C; Utili, R, 2016
)
0.43
" Adverse event rates were not significantly different between the two groups."( Similar efficacy and safety of daptomycin versus linezolid for treatment of vancomycin-resistant enterococcal bloodstream infections: a meta-analysis.
Chen, D; Ji, L; Liang, L; Patel, K; Zhang, Y; Zhao, M; Zhu, Y, 2016
)
0.43
" Two patients (4%) had to be readmitted because of complications; only one patient had an adverse effect related to daptomycin (increase in serum creatine kinase levels), which disappeared after discontinuation (2%)."( Safety and efficacy of daptomycin in outpatient parenteral antimicrobial therapy: a prospective and multicenter cohort study (DAPTODOM trial).
Antón, F; Basterretxea, A; Cervera, C; Cuende, A; García de la María, C; González-Ramallo, V; Miró, JM; Mirón, M; Pajarón, M; Sanclemente, G; Sanroma, P; Segado, A; Sopena, N, 2017
)
0.46
"Daptomycin was safe and efficacious in outpatients with Gram-positive bacterial infections and can be administered in 2-minute bolus infusion."( Safety and efficacy of daptomycin in outpatient parenteral antimicrobial therapy: a prospective and multicenter cohort study (DAPTODOM trial).
Antón, F; Basterretxea, A; Cervera, C; Cuende, A; García de la María, C; González-Ramallo, V; Miró, JM; Mirón, M; Pajarón, M; Sanclemente, G; Sanroma, P; Segado, A; Sopena, N, 2017
)
0.46
" In both groups, 15% of patients had drug-related adverse events, primarily diarrhea (4% daptomycin, 8% SOC) and increased creatine phosphokinase (4% daptomycin, 0% SOC)."( Randomized Multicenter Study Comparing Safety and Efficacy of Daptomycin Versus Standard-of-care in Pediatric Patients With Staphylococcal Bacteremia.
Arrieta, AC; Bensaci, M; Bokesch, P; Bradley, JS; Du, L; Glasser, C; Grandhi, A; Kartsonis, NA; Patino, H; Popejoy, MW, 2018
)
0.48
" Daptomycin in age-adjusted doses is a safe treatment alternative in this setting."( Randomized Multicenter Study Comparing Safety and Efficacy of Daptomycin Versus Standard-of-care in Pediatric Patients With Staphylococcal Bacteremia.
Arrieta, AC; Bensaci, M; Bokesch, P; Bradley, JS; Du, L; Glasser, C; Grandhi, A; Kartsonis, NA; Patino, H; Popejoy, MW, 2018
)
0.48
"Outpatient parenteral antimicrobial therapy (OPAT) is a safe and effective alternative to prolonged inpatient stays for patients requiring long-term intravenous antimicrobials, but antimicrobial-associated adverse events remain a significant challenge."( A retrospective analysis of adverse events among patients receiving daptomycin versus vancomycin during outpatient parenteral antimicrobial therapy.
Branch-Elliman, W; LaSalvia, MT; Schrank, GM; Wright, SB, 2018
)
0.48
" Additionally, these clinical enhancements of DAP therapy with loading dose were admitted without any enhancements of its adverse effect risks, except alkaline phosphatase elevation, compared with non-loading dose."( Retrospective study on clinical efficacy and safety for daptomycin intermittent doses with or without loading dose in renal failure patients.
Asai, N; Hagihara, M; Kato, H; Koizumi, Y; Mikamo, H; Shibata, Y; Watarai, M; Yamagishi, Y, 2020
)
0.56
" No serious adverse events or discontinuation of the drug occurred during the treatment period."( Efficacy and Safety of High Vs Standard Daptomycin Doses Examined in Chinese Patients With Severe Burn Injuries by Pharmacokinetic Evaluation.
Ding, L; Guo, N; Hu, L; Huang, Y; Li, Q; Liu, S; Lv, G; Shao, H; Wu, Y; Yang, Y; Zhu, Y, 2020
)
0.56
" The rate of drug-related adverse events was equally distributed in the HD and SD groups (36."( The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.
Chen, FZ; Dong, XM; Guan, YY; Li, QY; Wang, G; Xu, NN; Yao, YY; Zheng, F, 2020
)
0.56
"Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase."( The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.
Chen, FZ; Dong, XM; Guan, YY; Li, QY; Wang, G; Xu, NN; Yao, YY; Zheng, F, 2020
)
0.56
"Daptomycin is associated with a number of adverse effects including eosinophilic pneumonia, hypersensitivity reaction, myopathy, rhabdomyolysis, headache and transaminitis."( Safety outcomes with high-dose daptomycin in patients with acute kidney injury and/or end-stage renal disease.
Bond, M; Lorenz, AM; Smith, JM; Sobhanie, MM; Vlashyn, OO; Wardlow, L, 2021
)
0.62
"To determine the incidence and characteristics of significant adverse effects in patients receiving high-dose daptomycin with severe renal dysfunction."( Safety outcomes with high-dose daptomycin in patients with acute kidney injury and/or end-stage renal disease.
Bond, M; Lorenz, AM; Smith, JM; Sobhanie, MM; Vlashyn, OO; Wardlow, L, 2021
)
0.62
" Adverse events (AE) were reported in 42."( Efficacy and safety of daptomycin in Japanese pediatric participants with complicated skin and soft tissue infections or bacteremia caused by gram-positive cocci.
Iwata, S; Koyama, H; Murata, Y, 2022
)
0.72
"There is a growing concern about the association between the combined use of daptomycin (DAP) and statins and the occurrence of musculoskeletal adverse events (MAEs), but this remains controversial."( Association Between Statin Use and Daptomycin-related Musculoskeletal Adverse Events: A Mixed Approach Combining a Meta-analysis and a Disproportionality Analysis.
Asada, M; Bando, T; Chuma, M; Goda, M; Hamano, H; Ishizawa, K; Izawa-Ishizawa, Y; Kondo, Y; Miyata, K; Nakamoto, A; Niimura, T; Okada, N; Takechi, K; Tasaki, Y; Yagi, K; Yanagawa, H; Yoshioka, T; Zamami, Y, 2022
)
0.72
" Second, we conducted a disproportionality analysis using the US Food and Drug Administration Adverse Events Reporting System (FAERS) to further confirm the results of the meta-analysis and to examine the effect of each type of statin on DAP-related MAEs in a large population."( Association Between Statin Use and Daptomycin-related Musculoskeletal Adverse Events: A Mixed Approach Combining a Meta-analysis and a Disproportionality Analysis.
Asada, M; Bando, T; Chuma, M; Goda, M; Hamano, H; Ishizawa, K; Izawa-Ishizawa, Y; Kondo, Y; Miyata, K; Nakamoto, A; Niimura, T; Okada, N; Takechi, K; Tasaki, Y; Yagi, K; Yanagawa, H; Yoshioka, T; Zamami, Y, 2022
)
0.72
"Previous reports on daptomycin's adverse drug reactions (ADRs) have been insufficient, often because of limited data."( Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system.
Chen, JJ; Huo, XC; Wang, F; Wang, SX; Zhao, Q, 2022
)
0.72
"The study aimed to promote safe daptomycin prescribing by mining and evaluating the daptomycin ADR signals from the US Food and Drug Administration Adverse Event Reporting System (FAERS)."( Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system.
Chen, JJ; Huo, XC; Wang, F; Wang, SX; Zhao, Q, 2022
)
0.72
" Reports of rare adverse events, such as "necrotizing fasciitis and compartment syndrome," have emerged."( Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system.
Chen, JJ; Huo, XC; Wang, F; Wang, SX; Zhao, Q, 2022
)
0.72
" Clinical and microbiological responses, adverse events, relapse rate and mortality were considered."( Efficacy and safety of vancomycin for the treatment of Staphylococcus aureus bacteraemia: a systematic review and meta-analysis.
Cai, Y; Xu, J; Yang, T; Yin, H; Zhang, G; Zhang, N, 2023
)
0.91
"The efficacy of vancomycin in treating Staphylococcus aureus bacteraemia is still excellent but slightly inferior in adverse events."( Efficacy and safety of vancomycin for the treatment of Staphylococcus aureus bacteraemia: a systematic review and meta-analysis.
Cai, Y; Xu, J; Yang, T; Yin, H; Zhang, G; Zhang, N, 2023
)
0.91

Pharmacokinetics

We present pharmacokinetic (Pk) data of daptomycin given intravenously in a peritoneal dialysis patient. A standard population pharmacokinetics model was used to simulate 5,000 d aptomycin concentration-time profiles after 5 doses of 6 mg/kg of body weight/day.

ExcerptReferenceRelevance
" In this thesis pharmacodynamic parameters have been studied after brief exposure of gram-positive bacteria to daptomycin, imipenem or vancomycin and after short exposure of gram-negative bacteria to amikacin, ampicillin, aztreonam, cefepime, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, imipenem, mecillinam, or piperacillin."( Pharmacodynamic effects of antibiotics. Studies on bacterial morphology, initial killing, postantibiotic effect and effective regrowth time.
Hanberger, H, 1992
)
0.28
"The purpose of this study was to develop a pharmacodynamic model to describe the dependency of the rate of Staphylococcus aureus killing upon the concentration of daptomycin."( Investigation of the early killing of Staphylococcus aureus by daptomycin by using an in vitro pharmacodynamic model.
Larson, TA; Rotschafer, JC; Toscano, JP; Vance-Bryan, K, 1992
)
0.28
" To evaluate the impact of protein on daptomycin activity, a two-chamber in vitro pharmacodynamic model was used to study and compare the interaction between Staphylococcus aureus (clinical isolate) and either daptomycin or vancomycin, each in the presence and absence of physiologic human albumin concentrations."( Assessment of effects of protein binding on daptomycin and vancomycin killing of Staphylococcus aureus by using an in vitro pharmacodynamic model.
Garrison, MW; Larson, TA; Rotschafer, JC; Toscano, JP; Vance-Bryan, K, 1990
)
0.28
"Daptomycin is a new lipopeptide antibiotic for which preliminary pharmacokinetic data in adults have been limited to normal healthy volunteers and patients with renal insufficiency."( Clinical pharmacokinetics of daptomycin.
Novak, RM; Pryka, RD; Rodvold, KA; Wagner, DK, 1990
)
0.28
"To describe the pharmacodynamic profile of daptomycin against methicillin-resistant Staphylococcus aureus (MRSA) and Enterococci species based on bacterial density in an immunocompromised mouse thigh infection model."( Pharmacodynamic profile of daptomycin against Enterococcus species and methicillin-resistant Staphylococcus aureus in a murine thigh infection model.
Dandekar, PK; Nicolau, DP; Nightingale, CH; Tessier, PR; Williams, P, 2003
)
0.32
"The pharmacodynamic (PD) profile of daptomycin was determined against two MRSA, one vancomycin-resistant Enterococcus faecium, and one vancomycin-susceptible Enterococcus faecalis using the immunocompromised murine thigh model."( Pharmacodynamic profile of daptomycin against Enterococcus species and methicillin-resistant Staphylococcus aureus in a murine thigh infection model.
Dandekar, PK; Nicolau, DP; Nightingale, CH; Tessier, PR; Williams, P, 2003
)
0.32
" aureus (VRSA), an in vitro pharmacodynamic model with simulated endocardial vegetations incorporating protein and a high inoculum was used to simulate daptomycin, linezolid, quinupristin-dalfopristin, and vancomycin against the Michigan VRSA strain."( Bactericidal activities of daptomycin, quinupristin-dalfopristin, and linezolid against vancomycin-resistant Staphylococcus aureus in an in vitro pharmacodynamic model with simulated endocardial vegetations.
Brown, WJ; Cha, R; Rybak, MJ, 2003
)
0.32
" However, the pharmacodynamic (PD) profile of daptomycin is needed to relate the activity of the drug to biologically achievable concentrations."( Determination of the pharmacodynamic profile of daptomycin against Streptococcus pneumoniae isolates with varying susceptibility to penicillin in a murine thigh infection model.
Dandekar, PK; Nicolau, DP; Nightingale, CH; Tessier, PR; Williams, P; Zhang, C, 2004
)
0.32
"We utilized an in vitro pharmacodynamic model to simulate daptomycin regimens of 6 mg/kg/day under controlled conditions of pH, calcium and/or protein."( Influence of protein binding under controlled conditions on the bactericidal activity of daptomycin in an in vitro pharmacodynamic model.
Cha, R; Rybak, MJ, 2004
)
0.32
" Further antimicrobial studies that incorporate protein are warranted to assess the influence of protein in the pharmacodynamic evaluation of antimicrobials."( Influence of protein binding under controlled conditions on the bactericidal activity of daptomycin in an in vitro pharmacodynamic model.
Cha, R; Rybak, MJ, 2004
)
0.32
" The pharmacokinetic parameters of daptomycin were similar in both groups."( Moderate liver impairment has no influence on daptomycin pharmacokinetics.
Dvorchik, B, 2004
)
0.32
" The rate of change of Vz and CL with increasing BMI was greater when these pharmacokinetic parameters were expressed in absolute terms compared to when they were normalized for TBW or ideal body weight."( The pharmacokinetics of daptomycin in moderately obese, morbidly obese, and matched nonobese subjects.
Damphousse, D; Dvorchik, BH, 2005
)
0.33
"We inoculated an in vitro pharmacodynamic model simultaneously with clinical isolates of methicillin-resistant Staphylococcus aureus and an enterocin-producing enterococcus (vancomycin-resistant Enterococcus faecalis, ampicillin susceptible) at 7 log10 CFU/ml to examine enterocin effects and antimicrobial activity on staphylococci."( Impact of Enterococcus faecalis on the bactericidal activities of arbekacin, daptomycin, linezolid, and tigecycline against methicillin-resistant Staphylococcus aureus in a mixed-pathogen pharmacodynamic model.
Chin, JN; LaPlante, KL; Leuthner, KD; Rybak, MJ, 2006
)
0.33
" Our search of the literature found no published pediatric pharmacokinetic data."( Pharmacokinetics of daptomycin in a critically ill adolescent with vancomycin-resistant enterococcal endocarditis.
Akins, RL; Haase, MR; Levy, EN, 2006
)
0.33
" Other pharmacokinetic parameters measured on day 1 and at steady state were independent of the dose, including the half-life (approximately 8 h), weight-normalized plasma clearance (9 to 10 ml/h/kg), and volume of distribution (approximately 100 ml/kg)."( Pharmacokinetics and tolerability of daptomycin at doses up to 12 milligrams per kilogram of body weight once daily in healthy volunteers.
Benvenuto, M; Benziger, DP; Vigliani, G; Yankelev, S, 2006
)
0.33
" Noncompartmental analysis was used to determine the pharmacokinetic parameters, and these values were normalized against TBW, ideal body weight (IBW), and fat-free weight (FFW) for comparison of the two groups."( Influence of morbid obesity on the single-dose pharmacokinetics of daptomycin.
Anderson, T; Goade, DW; Mercier, RC; Norenberg, JP; Pai, MP; Rodvold, KA; Telepak, RA, 2007
)
0.34
" Daptomycin was quantitated from plasma using a validated high performance liquid chromatography method and pharmacokinetic variables determined using a model-dependent approach."( Single-dose pharmacokinetics of daptomycin in children with suspected or proved gram-positive infections.
Abdel-Rahman, SM; Benziger, DP; Hong, EF; Jacobs, RF; Jafri, HS; Kearns, GL, 2008
)
0.35
"76 ml/h/kg), the half-life was 11."( Daptomycin pharmacokinetics in adult oncology patients with neutropenic fever.
Bubalo, JS; Cherala, G; Hayes-Lattin, B; Maziarz, R; Munar, MY, 2009
)
0.35
"In this report we present pharmacokinetic (Pk) data of daptomycin given intravenously in a peritoneal dialysis patient."( Pharmacokinetics and dialysate levels of daptomycin given intravenously in a peritoneal dialysis patient.
Bode-Boger, SM; Burkhardt, O; Clajus, C; Goedecke, VA; Hiss, M; Kielstein, JT; Martens-Lobenhoffer, J, 2009
)
0.35
" A Hill-type pharmacodynamic mathematical model was fitted to the data to characterize the effect."( Daptomycin pharmacodynamics against Staphylococcus aureus hemB mutants displaying the small colony variant phenotype.
Begic, D; Tsuji, BT; von Eiff, C, 2009
)
0.35
"In Study 1, pharmacokinetic comparability between the two administration regimens was demonstrated by meeting the bioequivalence criteria for the exposure parameters, AUC(0-t), AUC(0-infinity) and C(max)."( Comparison of the pharmacokinetics, safety and tolerability of daptomycin in healthy adult volunteers following intravenous administration by 30 min infusion or 2 min injection.
Chakraborty, A; Chaves, RL; Loeffler, J; Roy, S, 2009
)
0.35
"The similar pharmacokinetic and safety profiles of the two administration regimens suggest that the 2 min iv injection may be a convenient treatment option for both patients and healthcare professionals."( Comparison of the pharmacokinetics, safety and tolerability of daptomycin in healthy adult volunteers following intravenous administration by 30 min infusion or 2 min injection.
Chakraborty, A; Chaves, RL; Loeffler, J; Roy, S, 2009
)
0.35
"In an in vitro pharmacodynamic model, linezolid attenuated the activity of aztreonam and ceftazidime against Escherichia coli."( Evaluating aztreonam and ceftazidime pharmacodynamics with Escherichia coli in combination with daptomycin, linezolid, or vancomycin in an in vitro pharmacodynamic model.
LaPlante, KL; Sakoulas, G, 2009
)
0.35
" aureus (VRSA), using high and low inocula in a pharmacokinetic in vitro model."( Comparative antibacterial effects of daptomycin, vancomycin and teicoplanin studied in an in vitro pharmacokinetic model of infection.
Bowker, KE; MacGowan, AP; Noel, AR, 2009
)
0.35
" This validated method was successfully applied to a pharmacokinetic study involving intravenous administration of 14mgkg(-1) DPT and 30mgkg(-1) RFM to rabbits."( Simultaneous quantification of daptomycin and rifampicin in plasma by ultra performance liquid chromatography: Application to a pharmacokinetic study.
Bazoti, FN; Fanourgiakis, P; Gikas, E; Perivolioti, E; Roussidis, A; Skoutelis, A; Tsarbopoulos, A, 2010
)
0.36
" Individual pharmacokinetic parameters determined by compartmental analysis were used to model trough serum concentrations at 44 and 68 hrs with 6-, 8- and 10-mg/kg post-haemodialysis doses."( Single-dose daptomycin pharmacokinetics in chronic haemodialysis patients.
Churchwell, MD; Gao, L; Heung, M; Mueller, BA; Patel, JH; Salama, NN; Segal, JH, 2010
)
0.36
" Daptomycin half-life was 19."( Single-dose daptomycin pharmacokinetics in chronic haemodialysis patients.
Churchwell, MD; Gao, L; Heung, M; Mueller, BA; Patel, JH; Salama, NN; Segal, JH, 2010
)
0.36
" A prospective, single-dose pharmacokinetic study was performed in the medical and surgical ICUs of a tertiary care center."( Dosing of daptomycin in intensive care unit patients with acute kidney injury undergoing extended dialysis--a pharmacokinetic study.
Bode-Boeger, SM; Burkhardt, O; Eugbers, C; Hafer, C; Haller, H; Joukhadar, C; Kielstein, JT; Knitsch, W; Martens-Lobenhoffer, J; Traunmüller, F, 2010
)
0.36
"Key pharmacokinetic parameters like half-life in critically ill patients treated with ED were comparable to healthy controls."( Dosing of daptomycin in intensive care unit patients with acute kidney injury undergoing extended dialysis--a pharmacokinetic study.
Bode-Boeger, SM; Burkhardt, O; Eugbers, C; Hafer, C; Haller, H; Joukhadar, C; Kielstein, JT; Knitsch, W; Martens-Lobenhoffer, J; Traunmüller, F, 2010
)
0.36
"Prospective, open-label pharmacokinetic study."( Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis.
Depestel, DD; Gao, L; Grio, M; Heung, M; Mueller, BA; Salama, NN; Sowinski, KM; Vilay, AM, 2011
)
0.37
" Equations describing a two-compartment, open-pharmacokinetic model were fitted to each subject's daptomycin concentration-time data and pharmacokinetic parameters were determined by standard methods."( Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis.
Depestel, DD; Gao, L; Grio, M; Heung, M; Mueller, BA; Salama, NN; Sowinski, KM; Vilay, AM, 2011
)
0.37
"6 mg/kg (mean ± sd) of daptomycin was administered, resulting in an observed peak concentration of 81."( Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis.
Depestel, DD; Gao, L; Grio, M; Heung, M; Mueller, BA; Salama, NN; Sowinski, KM; Vilay, AM, 2011
)
0.37
" The present article reviews the pharmacokinetic properties of vancomycin, linezolid, tigecycline and daptomycin."( Comparison of the pharmacokinetic properties of vancomycin, linezolid, tigecyclin, and daptomycin.
Derendorf, H; Estes, KS, 2010
)
0.36
" Pharmacokinetic parameters were described, and adverse events were monitored."( Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis.
Benziger, DP; Cannon, C; Donovan, J; Pertel, PE; Schwab, RJ; Swan, SK; Yankelev, S, 2011
)
0.37
" In CAPD subjects, Cmax was 93."( Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis.
Benziger, DP; Cannon, C; Donovan, J; Pertel, PE; Schwab, RJ; Swan, SK; Yankelev, S, 2011
)
0.37
" A series of 9,999-subject Monte Carlo simulations (MCS) was performed to identify HD dosing schemes providing efficacy and toxicity profiles comparable to those obtained for MCS employing the daptomycin population pharmacokinetic (PK) model derived from patients in the Staphylococcus aureus bacteremia-infective endocarditis (SAB-IE) study."( Use of pharmacokinetic and pharmacodynamic principles to determine optimal administration of daptomycin in patients receiving standardized thrice-weekly hemodialysis.
Cardone, K; Drusano, GL; Grabe, DW; Hoy, C; Lodise, TP; Manley, H; Meola, S; Patel, N, 2011
)
0.37
"A pharmacokinetic analysis was performed for single intravenous doses of daptomycin 8 or 10 mg/kg in subjects aged 2 to 6 years."( Single-dose pharmacokinetics and tolerability of daptomycin 8 to 10 mg/kg in children aged 2 to 6 years with suspected or proved Gram-positive infections.
Abdel-Rahman, SM; Akins, RL; Benziger, DP; Bradley, JS; Chandorkar, G; Donovan, J; Jacobs, RF, 2011
)
0.37
"This study sought to (1) characterize the pharmacokinetic (PK) profile of intravenous (i."( Pharmacokinetics and pharmacodynamics of intravenous daptomycin during continuous ambulatory peritoneal dialysis.
Cardone, KE; Drusano, GL; Grabe, DW; Hoy, CD; Lodise, TP; Manley, HJ; Meola, S; Patel, N, 2011
)
0.37
" Pharmacokinetic parameters of daptomycin in serum were calculated using standard noncompartmental methods, and daptomycin was assayed using high-performance liquid chromatography (for serum) or liquid chromatography with mass spectrometry (for CSF)."( Pharmacokinetics of single-dose daptomycin in patients with suspected or confirmed neurological infections.
Chin, JN; Coplin, WM; Edwards, DJ; Kullar, R; Parker, D; Rybak, MJ, 2011
)
0.37
"9 μg/ml, half-life [t(1/2)] = 8 h) and DAP at 10 mg/kg/day (fC(max) = 13."( Characterizing vancomycin-resistant Enterococcus strains with various mechanisms of daptomycin resistance developed in an in vitro pharmacokinetic/pharmacodynamic model.
Kaatz, GW; Rose, WE; Rybak, MJ; Steed, ME; Vidaillac, C; Winterfield, P, 2011
)
0.37
" In the CVVHD-treated patients, a loading dose of 8 mg/kg lead to Cmax of 87."( Plasma pharmacokinetics of daptomycin in critically ill patients with renal failure and undergoing CVVHD.
Eggers, K; Joukhadar, C; Khadzhynov, D; König, T; Lieker, I; Neumayer, HH; Peters, H; Puhlmann, B; Slowinski, T; Spies, C; Traunmüller, F; Uhrig, A, 2011
)
0.37
" Pharmacokinetic parameters were based on 10 sampling timepoints during the first 24 h, and peak and trough samples thereafter."( Multiple-dose pharmacokinetics of daptomycin during continuous venovenous haemodiafiltration.
Dittrich, P; Fuhrmann, V; Meyer, B; Saria, K; Thalhammer, F; Wenisch, JM; Zuba, C, 2012
)
0.38
"9 mL/min, and the elimination half-life was 17."( Multiple-dose pharmacokinetics of daptomycin during continuous venovenous haemodiafiltration.
Dittrich, P; Fuhrmann, V; Meyer, B; Saria, K; Thalhammer, F; Wenisch, JM; Zuba, C, 2012
)
0.38
"The methodology included the following steps: acquisition of microbiological and pharmacokinetic data, Monte Carlo simulation, estimation of the probability of target attainment (PTA), and calculation of the cumulative fraction of response (CFR)."( Pharmacokinetic-pharmacodynamic evaluation of daptomycin, tigecycline, and linezolid versus vancomycin for the treatment of MRSA infections in four western European countries.
Betriu, C; Canut, A; Gascón, AR; Isla, A, 2012
)
0.38
" The elimination half-life (t(1/2β)) of daptomycin was independent of the administered dose (38."( Daptomycin versus vancomycin in a methicillin-resistant Staphylococcus aureus endophthalmitis rabbit model: bactericidal effect, safety, and ocular pharmacokinetics.
Bourcier, T; Jehl, F; Lefèvre, S; Marcellin, L; Prévost, G; Saleh, M; Subilia, A, 2012
)
0.38
" aureus (MRSA) strain and the antibiotic pharmacodynamic profile against extracellular (broth) and intracellular (human THP-1 monocytes) bacteria."( Pharmacodynamic evaluation of the activity of antibiotics against hemin- and menadione-dependent small-colony variants of Staphylococcus aureus in models of extracellular (broth) and intracellular (THP-1 monocytes) infections.
Becker, K; Denis, O; Garcia, LG; Kahl, BC; Lemaire, S; Proctor, RA; Tulkens, PM; Van Bambeke, F, 2012
)
0.38
" The median area under the concentration curve at 24 hours, volume of distribution, total body clearance and half-life of daptomycin were 262."( Pharmacokinetics and tolerability of single-dose daptomycin in young infants.
Benjamin, DK; Cohen-Wolkowiez, M; Hornik, CP; Smith, PB; Watt, KM, 2012
)
0.38
"While the pharmacokinetic (PK) properties of daptomycin in hemodialysis (HD) patients have been evaluated previously by three groups, resultant dosing recommendations have varied."( Daptomycin pharmacokinetics and pharmacodynamics in a pooled sample of patients receiving thrice-weekly hemodialysis.
Butterfield, JM; Cardone, KE; Grabe, DW; Lodise, TP; Mueller, BA; Patel, N; Salama, NN, 2013
)
0.39
"Pharmacokinetic studies of daptomycin in septic patients indicate that pharmacokinetic parameters may be altered."( Variability of pharmacokinetic parameters in patients receiving different dosages of daptomycin: is therapeutic drug monitoring necessary?
Cassetta, MI; d'Ettorre, G; Falcone, M; Fallani, S; Lappa, A; Novelli, A; Russo, A; Tritapepe, L; Venditti, M, 2013
)
0.39
" Our aim was to set up a pharmacodynamic model comparing antibiotic activities against biofilms and examining in parallel their effects on viability and biofilm mass."( A combined pharmacodynamic quantitative and qualitative model reveals the potent activity of daptomycin and delafloxacin against Staphylococcus aureus biofilms.
Bauer, J; Siala, W; Tulkens, PM; Van Bambeke, F, 2013
)
0.39
" Population pharmacokinetic, pharmacodynamic and toxicodynamic models were developed based on current literature."( Pharmacokinetic/pharmacodynamic evaluation of the efficacy and safety of daptomycin against Staphylococcus aureus.
Brown, J; Forrest, A; Soon, RL; Tsuji, BT; Turner, SJ, 2013
)
0.39
"A population pharmacokinetic analysis of daptomycin was performed based on therapeutic drug monitoring (TDM) data from 58 patients receiving doses of 4-12 mg/kg for the treatment of severe Gram-positive infections."( Population pharmacokinetics of daptomycin in patients affected by severe Gram-positive infections.
Bocci, G; Danesi, R; Di Paolo, A; Gemignani, G; Karlsson, MO; Menichetti, F; Nielsen, EI; Polillo, M; Tascini, C, 2013
)
0.39
"To support daptomycin dosing recommendations in patients with Staphylococcus aureus bacteraemia (SAB) and severe renal impairment using simulations from a population pharmacokinetic model for daptomycin."( Clinical and pharmacokinetic considerations for the use of daptomycin in patients with Staphylococcus aureus bacteraemia and severe renal impairment.
Benziger, D; Chakraborty, A; Chaves, RL; Tannenbaum, S, 2014
)
0.4
"A population pharmacokinetic model was developed using 4875 daptomycin plasma concentrations from 442 subjects."( Clinical and pharmacokinetic considerations for the use of daptomycin in patients with Staphylococcus aureus bacteraemia and severe renal impairment.
Benziger, D; Chakraborty, A; Chaves, RL; Tannenbaum, S, 2014
)
0.4
" A standard population pharmacokinetic model was used to simulate 5,000 daptomycin concentration-time profiles after 5 doses of 6 mg/kg of body weight/day (0."( Simplified equations using two concentrations to calculate area under the curve for antimicrobials with concentration-dependent pharmacodynamics: daptomycin as a motivating example.
Falcone, M; Novelli, A; Pai, MP; Russo, A; Venditti, M, 2014
)
0.4
"In this phase 1, multicenter, open-label, noncomparative pharmacokinetic and safety study, patients were enrolled in 3 age groups: 3-6, 7-12 and 13-24 months."( Single-dose pharmacokinetics of daptomycin in pediatric patients 3-24 months of age.
Benziger, D; Bokesch, P; Bradley, JS; Jacobs, R, 2014
)
0.4
" Because no existing studies of this nature were available, Cmax following daptomycin 6 mg/kg/10 s multiple-dose bolus injections was simulated."( Evaluation of the safety, tolerability, and pharmacokinetics of a single bolus injection of daptomycin in healthy Japanese subjects.
Aoki, I; Aso, M; Ishikawa, K; Wakana, A; Yoshinari, T, 2015
)
0.42
"The clinical development of FtsZ-targeting benzamide compounds like PC190723 has been limited by poor drug-like and pharmacokinetic properties."( TXA709, an FtsZ-Targeting Benzamide Prodrug with Improved Pharmacokinetics and Enhanced In Vivo Efficacy against Methicillin-Resistant Staphylococcus aureus.
Kaul, M; LaVoie, EJ; Lyu, YL; Mark, L; Parhi, AK; Pawlak, J; Pilch, DS; Saravolatz, LD; Saravolatz, S; Weinstein, MP; Zhang, Y, 2015
)
0.42
"The relationships between pharmacokinetic (PK)/pharmacodynamic (PD) indices and outcomes were investigated in patients with skin and soft tissue infection (SSTI) who received daptomycin at 4 mg/kg/day."( Correlation between pharmacokinetic/pharmacodynamic indices and clinical outcomes in Japanese patients with skin and soft tissue infections treated with daptomycin: analysis of a phase III study.
Aikawa, N; Ishii, M; Kusachi, S; Mikamo, H; Takahashi, K; Takesue, Y; Watanabe, S; Yoshinari, T, 2015
)
0.42
"Pharmacodynamic activity in antibiotic combinations of daptomycin, vancomycin, and linezolid was investigated in a 48-h in vitro pharmacodynamic model."( Observed Antagonistic Effect of Linezolid on Daptomycin or Vancomycin Activity against Biofilm-Forming Methicillin-Resistant Staphylococcus aureus in an In Vitro Pharmacodynamic Model.
LaPlante, KL; Luther, MK, 2015
)
0.42
"The interindividual and intraindividual variabilities in daptomycin pharmacokinetics were investigated in 23 patients (69 pharmacokinetic profiles) who were treated for several months for bone and joint infections."( Pharmacokinetic Variability of Daptomycin during Prolonged Therapy for Bone and Joint Infections.
Ader, F; Chidiac, C; Ferry, T; Gagnieu, MC; Goutelle, S; Laurent, F; Lustig, S; Roux, S; Valour, F, 2016
)
0.43
" However, future studies need to address several issues to determine the optimal dose and various pharmacokinetic parameters in different pediatric age groups."( Clinical Effectiveness, Safety Profile, and Pharmacokinetics of Daptomycin in Pediatric Patients: A Systematic Review.
Dakoutrou, M; Karageorgos, SA; Miligkos, M; Tsioutis, C, 2016
)
0.43
"The objective of this population pharmacokinetic (PK) analysis was to provide guidance for the dosing interval of daptomycin in patients undergoing continuous renal replacement therapy (CRRT)."( Population pharmacokinetics of daptomycin in adult patients undergoing continuous renal replacement therapy.
Chaves, RL; Corti, N; Hamed, K; Khadzhynov, D; Levi, M; Peters, H; Xu, X, 2017
)
0.46
" The protocol will further continue to assess whether a higher dose achieves the pharmacokinetic objectives."( Pharmacokinetics of Intraperitoneal Daptomycin in Patients with Peritoneal Dialysis-Related Peritonitis.
Bouvier, N; Cattoir, V; Debruyne, D; Ficheux, M; Fournel, F; Lobbedez, T; Loilier, M; Morello, R; Parienti, JJ; Peyro Saint Paul, L; Verdon, R, 2017
)
0.46
"5, 1, 2, 3, 5, 7, 9 and 12 h after dosing) to assess the pharmacokinetic profile of daptomycin."( Population pharmacokinetics and dosing considerations for the use of daptomycin in adult patients with haematological malignancies.
Candoni, A; Cojutti, PG; Fanin, R; Hope, W; Lazzarotto, D; Pea, F; Ramos-Martin, V; Zannier, ME, 2017
)
0.46
" Pharmacokinetic parameters after single oral administration of optimized proliposomal formulation indicated a significant increase in oral bioavailability of DAP administered as SPC-SA proliposomes when compared to drug solution."( Daptomycin Proliposomes for Oral Delivery: Formulation, Characterization, and In Vivo Pharmacokinetics.
Arregui, JR; Betageri, GV; Kovvasu, SP, 2018
)
0.48
" However, pharmacodynamic targets associated with positive patient outcomes are undefined."( Pharmacodynamic Analysis of Daptomycin-treated Enterococcal Bacteremia: It Is Time to Change the Breakpoint.
Aitken, SL; Arias, CA; Avery, LM; Britt, NS; Chong, PP; Contreras, GA; DiPippo, AJ; Egli, A; Kuti, JL; Nicolau, DP; Rybak, MJ; Wang, JT; Weisser, M; Zasowski, EJ, 2019
)
0.51
" Daptomycin exposures were calculated using a published population pharmacokinetic model."( Pharmacodynamic Analysis of Daptomycin-treated Enterococcal Bacteremia: It Is Time to Change the Breakpoint.
Aitken, SL; Arias, CA; Avery, LM; Britt, NS; Chong, PP; Contreras, GA; DiPippo, AJ; Egli, A; Kuti, JL; Nicolau, DP; Rybak, MJ; Wang, JT; Weisser, M; Zasowski, EJ, 2019
)
0.51
" Total and unbound plasma concentrations and urine concentrations of daptomycin were analysed simultaneously following a population pharmacokinetic approach."( Population pharmacokinetics of daptomycin in critically ill patients with various degrees of renal impairment.
Asehnoune, K; Barbaz, M; Couet, W; Ferrandière, M; Gaillard, T; Grégoire, N; Lasocki, S; Launey, Y; Marchand, S; Mimoz, O; Seguin, P; Vourc'h, M, 2019
)
0.51
" Simulations performed with the final model examined the influence of covariates on the probability to achieve pharmacodynamic (PD) targets."( Genetic polymorphisms of ABCB1 (P-glycoprotein) as a covariate influencing daptomycin pharmacokinetics: a population analysis in patients with bone and joint infection.
Becker, A; Bricca, R; Chidiac, C; Conrad, A; Ferry, T; Gagnieu, MC; Goutelle, S; Laurent, F; Roux, S; Triffault-Fillit, C; Valour, F, 2019
)
0.51
" Exposures were calculated using a published population pharmacokinetic model based on creatinine clearance, 90% protein binding and daptomycin Etest MIC."( Pharmacodynamics of daptomycin in combination with other antibiotics for the treatment of enterococcal bacteraemia.
Aitken, SL; Arias, CA; Avery, LM; Britt, NS; Chong, PP; Contreras, GA; DiPippo, AJ; Egli, A; Kuti, JL; Nicolau, DP; Rybak, MJ; Wang, JT; Weisser, M; Zasowski, EJ, 2019
)
0.51
" In the current study relationships between DAP Cmin and CPK elevation were investigated, and optimal DAP doses were determined."( Observational study to determine the optimal dose of daptomycin based on pharmacokinetic/pharmacodynamic analysis.
Katsumata, T; Kawanishi, F; Nakano, T; Nishihara, M; Oda, K; Ooi, Y; Shibata, Y; Suzuki, K; Uchida, T; Ukimura, A; Yamada, T; Yoshida, M, 2020
)
0.56
" In silico pharmacodynamic models based on stochastic simulations (Monte Carlo) are important tools to estimate best antimicrobial regimens in different scenarios."( Pharmacodynamic comparison of different antimicrobial regimens against Staphylococcus aureus bloodstream infections with elevated vancomycin minimum inhibitory concentration.
Cuba, GT; da Costa, TM; Dos Santos, KRN; Kiffer, CRV; Morgado, PGM; Nicolau, DP; Nouér, SA, 2020
)
0.56
" The study retrospectively analyzed 10 patients with severe burn injuries, using pharmacokinetic (PK) and pharmacodynamic (PD) evaluations of daptomycin doses given to combat serious infections."( Efficacy and Safety of High Vs Standard Daptomycin Doses Examined in Chinese Patients With Severe Burn Injuries by Pharmacokinetic Evaluation.
Ding, L; Guo, N; Hu, L; Huang, Y; Li, Q; Liu, S; Lv, G; Shao, H; Wu, Y; Yang, Y; Zhu, Y, 2020
)
0.56
" Monte Carlo simulations (MCSs) were conducted using pharmacokinetic (PK) parameters and pharmacodynamic (PD) data to determine the probabilities of target attainment and cumulative fractions of response in terms of area under the concentration curve/minimum inhibition concentration (MIC) targets of daptomycin."( Pharmacokinetic/Pharmacodynamic Analysis of Daptomycin Against Staphylococcus aureus and Enterococcus faecium in Pediatric Patients by Monte Carlo Simulation.
Li, X; Wei, XC; Xiao, X; Zhao, MF, 2020
)
0.56
"Individual concentration data of 32 CRRT subjects pooled from previously published studies were used to construct the population pharmacokinetic model for daptomycin."( Population pharmacokinetics and dosing considerations of daptomycin in critically ill patients undergoing continuous renal replacement therapy.
Cheng, Z; Li, S; Xie, F, 2020
)
0.56
"We performed population pharmacokinetic analysis of the unbound concentrations of daptomycin."( Population Pharmacokinetic Analysis and Dosing Optimization Based on Unbound Daptomycin Concentration and Cystatin C in Nonobese Elderly Patients with Hypoalbuminemia and Chronic Kidney Disease.
Enoki, Y; Higashita, R; Ito, H; Koshioka, S; Kunika, N; Kurata, T; Matsumoto, K; Nagumo, F; Samura, M; Taguchi, K; Takada, K; Tanikawa, K; Uchida, M; Yamamoto, R, 2021
)
0.62
"In the population pharmacokinetic analysis of 25 patients aged ≥65 years, the two-compartment model using eGFRcys and age as covariates of clearance in central compartment of unbound daptomycin were optimal."( Population Pharmacokinetic Analysis and Dosing Optimization Based on Unbound Daptomycin Concentration and Cystatin C in Nonobese Elderly Patients with Hypoalbuminemia and Chronic Kidney Disease.
Enoki, Y; Higashita, R; Ito, H; Koshioka, S; Kunika, N; Kurata, T; Matsumoto, K; Nagumo, F; Samura, M; Taguchi, K; Takada, K; Tanikawa, K; Uchida, M; Yamamoto, R, 2021
)
0.62
" Current guidelines recommend higher daptomycin doses (8-10 mg/kg) for severe infections; however, pharmacokinetic (PK) and pharmacodynamic-based dosing strategies are still limited."( Simplified daptomycin dosing regimen for adult patients with methicillin-resistant Staphylococcus aureus infections based on population pharmacokinetic analysis.
Egashira, N; Ieiri, I; Kitaichi, K; Maeshiro, Y; Miyake, N; Nishida, R; Oida, Y; Shimono, N; Soda, M; Yamada, T; Yamashita, Y, 2022
)
0.72
" We sought to establish a physiologically based pharmacokinetic (PBPK) model of daptomycin to describe the dynamics of daptomycin disposition in bone and skin tissue."( Daptomycin Physiology-Based Pharmacokinetic Modeling to Predict Drug Exposure and Pharmacodynamics in Skin and Bone Tissues.
Bourguignon, L; Ferry, T; Garreau, R; Goutelle, S; Grillon, A; Jehl, F; Montange, D, 2022
)
0.72
"5 and 2 for all pharmacokinetic quantities in blood, skin and bone tissues."( Daptomycin Physiology-Based Pharmacokinetic Modeling to Predict Drug Exposure and Pharmacodynamics in Skin and Bone Tissues.
Bourguignon, L; Ferry, T; Garreau, R; Goutelle, S; Grillon, A; Jehl, F; Montange, D, 2022
)
0.72
" We developed a population pharmacokinetic model to predict both total and unbound daptomycin concentrations."( Population Pharmacokinetic Model for Unbound Concentrations of Daptomycin in Patients with MRSA Including Patients Undergoing Hemodialysis.
Holford, N; Kasai, H; Kawasuji, H; Ogami, C; Takahashi, S; To, H; Tsuji, Y; Yamamoto, Y, 2023
)
0.91
"Physiologically based pharmacokinetic models were developed from pharmacokinetic studies of healthy adults, geriatric, paediatric, obese and RI patients."( Physiologically based pharmacokinetic modelling to inform combination dosing regimens of ceftaroline and daptomycin in special populations.
Annaert, P; Martins, FS; Martins, JES; Severino, P; Sy, SKB, 2023
)
0.91
"Our work illustrates how physiologically based pharmacokinetic modelling can inform appropriate dosing of adult and paediatric patients and thereby enable prediction of target attainment in the patients during multitherapies."( Physiologically based pharmacokinetic modelling to inform combination dosing regimens of ceftaroline and daptomycin in special populations.
Annaert, P; Martins, FS; Martins, JES; Severino, P; Sy, SKB, 2023
)
0.91

Compound-Compound Interactions

H2-60 combined with daptomycin exhibit the excellent antibacterial and anti-biofilm activity against E. faecium. Synergy was demonstrated when HSM1 was combined with vancomycin and dptomycin. D aptomycin in combination with rifampicin needs to be assessed in bone infection.

ExcerptReferenceRelevance
"Using an experimental endocarditis model, we studied the activity of daptomycin used alone or in combination with gentamicin against an Enterococcus faecium strain that was highly resistant to glycopeptides and susceptible to gentamicin."( Daptomycin or teicoplanin in combination with gentamicin for treatment of experimental endocarditis due to a highly glycopeptide-resistant isolate of Enterococcus faecium.
Carbon, C; Caron, F; Cremieux, AC; Gutmann, L; Kitzis, MD; Lemeland, JF; Maziere, B; Saleh-Mghir, A; Vallois, JM, 1992
)
0.28
" The bactericidal effect obtained with daptomycin in combination with aminoglycosides suggest that further evaluation of these combinations in enterococcal endocarditis could have a clinical interest if this bactericidal effect was confirmed by in vivo studies."( [Bactericidal activity of daptomycin and vancomycin alone or in combination with tobramycin, netilmicin or ampicillin against enterococcus].
Cordin, X; Duez, JM; Kazmierczak, A; Péchinot, A; Siébor, E, 1989
)
0.28
"The antibacterial activity of LY146032 alone and in combination with other drugs was assayed against gram-positive isolates."( In vitro activity of LY146032 alone and in combination with other antibiotics against gram-positive bacteria.
Debbia, E; Pesce, A; Schito, GC, 1988
)
0.27
" Daptomycin in combination with ampicillin, rifampin, and gentamicin was tested against enterococci; daptomycin in combination with ampicillin-sulbactam, piperacillin-tazobactam, and ticarcillin-clavulanate was tested against staphylococci."( In vitro activity of daptomycin alone and in combination with various antimicrobials against Gram-positive cocci.
Aydemir, S; Cilli, F; Tunger, A, 2006
)
0.33
" Daptomycin sub-MICs combined with gentamicin concentrations lower than the MIC yielded synergy in 34 (68%) of the 50 strains."( Activity of daptomycin alone and in combination with rifampin and gentamicin against Staphylococcus aureus assessed by time-kill methodology.
Appelbaum, PC; Credito, K; Lin, G, 2007
)
0.34
"3 log(10) CFU/ml, whereas in combination with rifampin, a reduction in the counts of >6 log(10) CFU/ml was observed."( Efficacy of daptomycin in implant-associated infection due to methicillin-resistant Staphylococcus aureus: importance of combination with rifampin.
Baldoni, D; Haschke, M; John, AK; Rentsch, K; Schaerli, P; Trampuz, A; Zimmerli, W, 2009
)
0.35
" We investigated the effects of vancomycin (VAN), daptomycin (DAP), fosfomycin (FOS), tigecycline (TGC), and ceftriaxone (CRX), alone and in combination with azithromycin (AZI), on established biofilms of Staphylococcus epidermidis."( Effects of azithromycin in combination with vancomycin, daptomycin, fosfomycin, tigecycline, and ceftriaxone on Staphylococcus epidermidis biofilms.
Graninger, W; Hajdu, S; Hirschl, AM; Holinka, J; Lassnigg, AM; Presterl, E, 2009
)
0.35
" The purpose of the present study was to quantify the biofilm formation of methicillin (meticillin)-resistant Staphylococcus aureus (MRSA) isolates obtained from patients with IE and to evaluate the in vitro activities of daptomycin and vancomycin alone and in combination with rifampin (rifampicin) or gentamicin while monitoring the isolates for the development of resistance."( Activities of daptomycin and vancomycin alone and in combination with rifampin and gentamicin against biofilm-forming methicillin-resistant Staphylococcus aureus isolates in an experimental model of endocarditis.
LaPlante, KL; Woodmansee, S, 2009
)
0.35
" aureus (four MRSA and two GISA) and four strains of enterococci (two Enterococcus faecalis and two Enterococcus faecium) were serially exposed in broth to two-fold stepwise increasing concentrations of daptomycin alone or in combination with a fixed concentration [0."( In vitro prevention of the emergence of daptomycin resistance in Staphylococcus aureus and enterococci following combination with amoxicillin/clavulanic acid or ampicillin.
Entenza, JM; Giddey, M; Moreillon, P; Vouillamoz, J, 2010
)
0.36
" Simulated regimens included vancomycin (VAN) plus rifampin (RIF), moxifloxacin (MOX), and high doses (10 mg/kg of body weight/day) of daptomycin (DAP) alone or combined with RIF or clarithromycin (CLA)."( Activities of high-dose daptomycin, vancomycin, and moxifloxacin alone or in combination with clarithromycin or rifampin in a novel in vitro model of Staphylococcus aureus biofilm.
Parra-Ruiz, J; Rose, WE; Rybak, MJ; Vidaillac, C, 2010
)
0.36
" Daptomycin in combination with rifampicin needs to be assessed in bone infection."( Efficacy of daptomycin combined with rifampicin for the treatment of experimental meticillin-resistant Staphylococcus aureus (MRSA) acute osteomyelitis.
Amador, G; Asseray, N; Caillon, J; Jacqueline, C; Le Mabecque, V; Lefebvre, M; Miegeville, A; Potel, G, 2010
)
0.36
" The aim of this study was to evaluate the efficacies of daptomycin at usual and high doses (equivalent to 6 and 10 mg/kg of body weight/day, respectively, in humans) and in combination with rifampin and to compare the activities to those of conventional anti-MRSA therapies."( Efficacy of usual and high doses of daptomycin in combination with rifampin versus alternative therapies in experimental foreign-body infection by methicillin-resistant Staphylococcus aureus.
Ariza, J; Cabellos, C; Cabo, J; Euba, G; Garrigós, C; Murillo, O; Tubau, F; Verdaguer, R, 2010
)
0.36
" Synergy was demonstrated when HSM1 was combined with vancomycin and daptomycin."( In vitro activity and in vivo efficacy of the saponin diosgenyl 2-amino-2-deoxy-β-D-glucopyranoside hydrochloride (HSM1) alone and in combination with daptomycin and vancomycin against Gram-positive cocci.
Brescini, L; Cirioni, O; Dawgul, M; Ghiselli, R; Giacometti, A; Guerrieri, M; Kamysz, W; Myszka, H; Orlando, F; Silvestri, C, 2011
)
0.37
" In conclusion, our results suggested a strong activity of tigecycline alone and in combination with other antimicrobial agents against multi-resistant Gram-positive organisms isolated from wound infections."( In vitro activity and in vivo efficacy of tigecycline alone and in combination with daptomycin and rifampin against Gram-positive cocci isolated from surgical wound infection.
Arzeni, D; Brescini, L; Cirioni, O; Ganzetti, G; Ghiselli, R; Giacometti, A; Guerrieri, M; Offidani, A; Orlando, F; Provinciali, M; Silvestri, C; Simonetti, O; Staffolani, S, 2012
)
0.38
" This investigation assessed risk for myopathy in patients receiving treatment with a statin in combination with daptomycin, a medication also associated with muscle injury."( Statins and daptomycin: safety assessment of concurrent use and evaluation of drug interaction liability.
Barber, GR; Barron, MA; Golightly, LK; Page, RL, 2013
)
0.39
" Risk of muscle injury therefore appears to be no greater when a statin is administered with daptomycin than when either medication is used alone."( Statins and daptomycin: safety assessment of concurrent use and evaluation of drug interaction liability.
Barber, GR; Barron, MA; Golightly, LK; Page, RL, 2013
)
0.39
"Treatment of Gram-positive osteoarticular infections requires an adequate surgical approach combined with intensive antimicrobial therapy."( The safety and efficacy of high-dose daptomycin combined with rifampicin for the treatment of Gram-positive osteoarticular infections.
Garbino, J; Hoffmeyer, P; Jugun, K; Lew, D; Pagani, L; Uçkay, I; Vaudaux, P, 2013
)
0.39
"The activity of colistin in combination with daptomycin was assessed using 30 Gram-negative type strains and multidrug-resistant isolates with defined mechanisms of resistance."( In vitro activity of daptomycin in combination with low-dose colistin against a diverse collection of Gram-negative bacterial pathogens.
Hornsey, M; Phee, L; Wareham, DW, 2013
)
0.39
" Daptomycin, in combination with other antibiotics, has been successfully used in the treatment of these infections, with the aims of resulting in reducing the prevention of antimicrobial resistance and increased killing compared with daptomycin monotherapy."( Daptomycin in combination with other antibiotics for the treatment of complicated methicillin-resistant Staphylococcus aureus bacteremia.
Dhand, A; Sakoulas, G, 2014
)
0.4
"There are limited clinical data on the use of daptomycin in combination with other antibiotics."( Daptomycin in combination with other antibiotics for the treatment of complicated methicillin-resistant Staphylococcus aureus bacteremia.
Dhand, A; Sakoulas, G, 2014
)
0.4
"Use of daptomycin in combination with other antibiotics, especially β-lactams, offers a promising treatment option for complicated MRSA bacteremia in which emergence of resistance during treatment may be anticipated."( Daptomycin in combination with other antibiotics for the treatment of complicated methicillin-resistant Staphylococcus aureus bacteremia.
Dhand, A; Sakoulas, G, 2014
)
0.4
" Of studied drugs, daptomycin was the common element in the most active regimens when combined with doxycycline plus either beta-lactams (cefoperazone or carbenicillin) or an energy inhibitor (clofazimine)."( Drug combinations against Borrelia burgdorferi persisters in vitro: eradication achieved by using daptomycin, cefoperazone and doxycycline.
Auwaerter, PG; Feng, J; Zhang, Y, 2015
)
0.42
" This study systematically evaluated by in vitro time-kill studies the effect of daptomycin in combination with ampicillin, cefazolin, ceftriaxone, ceftaroline, ertapenem, gentamicin, tigecycline, and rifampin, for a collection of 9 daptomycin-NS enterococci that exhibited a broad range of MICs and different resistance-conferring mutations."( In vitro activity of daptomycin in combination with β-lactams, gentamicin, rifampin, and tigecycline against daptomycin-nonsusceptible enterococci.
Carvalho, M; Charlton, CL; Hindler, JA; Humphries, R; Kelesidis, T; Miller, SA; Nizet, V; Nonejuie, P; Pogliano, J; Sakoulas, G; Wong-Beringer, A, 2015
)
0.42
" aureus activity of P128 alone and in combination with standard-of-care antibiotics on planktonic and biofilm-embedded cells."( Antibiofilm Activity and Synergistic Inhibition of Staphylococcus aureus Biofilms by Bactericidal Protein P128 in Combination with Antibiotics.
Desai, S; Nair, S; Poonacha, N; Sharma, U; Vipra, A, 2016
)
0.43
"This study aimed to explore daptomycin combined with fosfomycin or rifampin against the planktonic and adherent linezolid-resistant isolates of Enterococcus faecalis."( In vitro activities of daptomycin combined with fosfomycin or rifampin on planktonic and adherent linezolid-resistant isolates of Enterococcus faecalis.
Chen, Z; Deng, QW; Jiang, SB; Lin, ZW; Qi, GB; Qu, D; Sun, X; Tu, HP; Wu, Y; Yu, ZJ; Zheng, JX, 2019
)
0.51
"Daptomycin is commonly prescribed in combination with other antibiotics for treatment of enterococcal bacteraemia."( Pharmacodynamics of daptomycin in combination with other antibiotics for the treatment of enterococcal bacteraemia.
Aitken, SL; Arias, CA; Avery, LM; Britt, NS; Chong, PP; Contreras, GA; DiPippo, AJ; Egli, A; Kuti, JL; Nicolau, DP; Rybak, MJ; Wang, JT; Weisser, M; Zasowski, EJ, 2019
)
0.51
" In the in vivo EE model, the following antibiotic combinations were evaluated: cloxacillin (2 g/4 h) alone or combined with gentamicin (1 mg/kg/8 h) or daptomycin (6 mg/kg once daily); and daptomycin (6 mg/kg/day) alone or combined with fosfomycin (2 g/6 h)."( Cloxacillin or fosfomycin plus daptomycin combinations are more active than cloxacillin monotherapy or combined with gentamicin against MSSA in a rabbit model of experimental endocarditis.
Almela, M; Ambrosioni, J; Cañas, MA; Castañeda, X; Falces, C; Fuster, D; García-de-la-Mària, C; García-González, J; Gasch, O; Hernández-Meneses, M; Llopis, J; Marco, F; Miró, JM; Moreno, A; Pericàs, JM; Quintana, E; Sandoval, E; Soy, D; Téllez, A; Tolosana, JM; Vidal, B, 2020
)
0.56
" When given for four daily doses, both lysin dose regimens in combination with daptomycin sterilized all target tissues."( Efficacy of Antistaphylococcal Lysin LSVT-1701 in Combination with Daptomycin in Experimental Left-Sided Infective Endocarditis Due to Methicillin-Resistant Staphylococcus aureus.
Abdelhady, W; Bayer, AS; Borroto-Esoda, K; Gaukel, E; Huang, DB; Kerzee, N; Lowry, S; Xiong, YQ, 2021
)
0.62
" faecium with monotherapy or its combination with daptomycin by time-killing assay."( In vitro activities of thiazolidione derivatives combined with daptomycin against clinical Enterococcus faecium strains.
Chen, J; Chen, Z; Deng, Q; Qu, D; Tang, Y; Wu, Y; Xiong, Y; Yu, Z; Zhao, Y; Zheng, J, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
" The good peritoneal bioavailability of DAP was quantitatively established, suggesting that IP administration could also be used as an alternate route for patients with damaged venous access."( Pharmacokinetics of Intraperitoneal Daptomycin in Patients with Peritoneal Dialysis-Related Peritonitis.
Bouvier, N; Cattoir, V; Debruyne, D; Ficheux, M; Fournel, F; Lobbedez, T; Loilier, M; Morello, R; Parienti, JJ; Peyro Saint Paul, L; Verdon, R, 2017
)
0.46
" Pharmacokinetic parameters after single oral administration of optimized proliposomal formulation indicated a significant increase in oral bioavailability of DAP administered as SPC-SA proliposomes when compared to drug solution."( Daptomycin Proliposomes for Oral Delivery: Formulation, Characterization, and In Vivo Pharmacokinetics.
Arregui, JR; Betageri, GV; Kovvasu, SP, 2018
)
0.48
" Although some of the biological factors have been reported that regulate intestinal permeation of cyclic peptides, the influence of the mucus barrier, a major hurdle to epithelial drug delivery, on cyclic peptide bioavailability is unclear."( The lipophilic cyclic peptide cyclosporin A induces aggregation of gel-forming mucins.
Kishimoto, H; Ridley, C; Thornton, DJ, 2022
)
0.72
"This study is an economic analysis seeking to examine cost savings that may be accrued from usage of oral linezolid in place of OPAT IV daptomycin in patients requiring prolonged courses of IV or highly bioavailable oral antibiotic therapy."( A cost minimisation analysis comparing oral linezolid and intravenous daptomycin administered via an outpatient parenteral antibiotic therapy programme in patients requiring prolonged antibiotic courses.
Faller, E; Jackson, A, 2023
)
0.91

Dosage Studied

Daptomycin, a cyclic lipopeptide antibiotic with concentration-dependent bactericidal activity, is the preferred treatment option for VRE bacteraemia. The optimal dosing strategy for this indication has not been established.

ExcerptRelevanceReference
" Animals infected with strain SF-195 received 5 days of no therapy, ampicillin, ampicillin-gentamicin, vancomycin, or daptomycin (all at the dosage regimens described above)."( Comparison of daptomycin, vancomycin, and ampicillin-gentamicin for treatment of experimental endocarditis caused by penicillin-resistant enterococci.
Bayer, AS; Eliopoulos, GM; Grayson, ML; Ramos, MC, 1992
)
0.28
" High protein binding of daptomycin (> 90%) and the lower-than-expected concentrations in serum with the dosage regimen of 3 mg/kg of body weight every 12 h may have contributed to these failures."( In vitro pharmacodynamic effects of concentration, pH, and growth phase on serum bactericidal activities of daptomycin and vancomycin.
Bailey, EM; Kaatz, GW; Lamp, KC; Rybak, MJ, 1992
)
0.28
" Two dosage regimens of each drug were used: 10 mg/kg and 5 mg/kg administered every 12 h for 14 days."( Daptomycin versus vancomycin treatment for Staphylococcus aureus bacteremia in a murine model.
Avent, K; Cobbs, G; Dill, R; Graves, A; Lyon, D; Smith, K, 1990
)
0.28
" It is likely that the clinical efficacy of daptomycin in humans would be enhanced by higher dosing than has been studied to date."( Effect of human serum on the bactericidal activity of daptomycin and vancomycin against staphylococcal and enterococcal isolates as determined by time-kill kinetic studies.
Stratton, CW; Weeks, LS,
)
0.13
" The sponsor of daptomycin is currently reevaluating the recommendation and may be revising their dosage guidelines in the future."( Suboptimal effect of daptomycin in the treatment of bacteremias.
Crossley, KB; Garrison, MW; Rotschafer, JC, 1989
)
0.28
" To guide the clinical dosing regimen with the potential for the least effect on skeletal muscle, two studies were conducted with dogs to compare the effects of repeated intravenous administration every 24 h versus every 8 h for 20 days."( Once-daily dosing in dogs optimizes daptomycin safety.
Berman, CL; Kirkpatrick, JB; Lai, JJ; Oleson, FB; Regan, KS; Tally, FP, 2000
)
0.31
" Among them, only the once-daily dosing of aminoglycosides has been brought to the clinic and physicians are now increasingly adopting this approach to reduce the toxicity of these agents."( Aminoglycoside nephrotoxicity: do time and frequency of administration matter?
Beauchamp, D; Labrecque, G, 2001
)
0.31
" For all three doses, plasma daptomycin concentrations were consistent and predictable throughout the dosing interval."( Daptomycin pharmacokinetics and safety following administration of escalating doses once daily to healthy subjects.
Arbeit, RD; Brazier, D; DeBruin, MF; Dvorchik, BH, 2003
)
0.32
" We employed pharmacodynamic modeling to determine a once-daily dosing regimen of daptomycin that correlates to pharmacodynamic endpoints for different resistant gram-positive clinical strains."( Daptomycin dose-effect relationship against resistant gram-positive organisms.
Cha, R; Grucz, RG; Rybak, MJ, 2003
)
0.32
" Drug dosage should be adapted to obtain inflammatory fluid levels of daptomycin minimizing emergence of resistant subpopulations."( Comparative efficacy of daptomycin and vancomycin in the therapy of experimental foreign body infection due to Staphylococcus aureus.
Bisognano, C; Francois, P; Lew, DP; Li, D; Schrenzel, J; Vaudaux, P, 2003
)
0.32
" In pursuit of potential clinical dosing regimens for endocarditis, we evaluated two, once-daily daptomycin regimens against multiple, drug-resistant Gram-positive pathogens."( Daptomycin against multiple drug-resistant staphylococcus and enterococcus isolates in an in vitro pharmacodynamic model with simulated endocardial vegetations.
Cha, R; Rybak, MJ, 2003
)
0.32
"At the conclusion of this learning activity, participants should be familiar with the modes of action, clinical indications, dosage regimens, and contraindications and cautions for several novel antibacterial agents for skin and skin structure infections."( Novel antibacterial agents for skin and skin structure infections.
Schweiger, ES; Weinberg, JM, 2004
)
0.32
" This analysis supports the dosing of daptomycin on a milligram-per-kilogram-of-body-weight basis and suggests that modified dosing regimens are indicated for patients with severe renal disease and for those undergoing dialysis."( Population pharmacokinetics of daptomycin.
Arbeit, RD; Chung, J; Dvorchik, B; Kastrissios, H; Knebel, W; Liu, S, 2004
)
0.32
" Once-daily dosing has diminished the preclinical incidence of myopathy."( Muscle pain associated with daptomycin.
Louie, KR; Malesker, MA; Smith, PW; Veligandla, SR, 2004
)
0.32
" Human therapeutic dosing regimens for nafcillin, daptomycin, vancomycin, linezolid, and gentamicin were simulated."( Impact of high-inoculum Staphylococcus aureus on the activities of nafcillin, vancomycin, linezolid, and daptomycin, alone and in combination with gentamicin, in an in vitro pharmacodynamic model.
LaPlante, KL; Rybak, MJ, 2004
)
0.32
" Daptomycin may be dosed based on total body weight, and no adjustment in daptomycin dose or dose regimen should be required based solely on obesity."( The pharmacokinetics of daptomycin in moderately obese, morbidly obese, and matched nonobese subjects.
Damphousse, D; Dvorchik, BH, 2005
)
0.33
" No dosage adjustment appears to be necessary for mild to moderate hepatic impairment."( Daptomycin: a cyclic lipopeptide antimicrobial agent.
Fung, HB; Jeu, L, 2004
)
0.32
" A dosage of 4 mg/kg intravenous once a day has been shown to be efficacious in two evaluator-blinded trials of complicated skin and soft tissue infections with clinical success rates similar for daptomycin and comparators (vancomycin or penicillinase-resistant penicillins)."( The need for new therapeutic agents: what is the pipeline?
Shah, PM, 2005
)
0.33
"The development, activity, pharmacokinetics, pharmacodynamics, clinical efficacy, adverse effects, and dosage and administration of daptomycin are reviewed."( Daptomycin: a novel cyclic lipopeptide antimicrobial.
Danziger, LH; Fernández, C; Rodvold, KA; Schriever, CA, 2005
)
0.33
" Human therapeutic dosing regimens for daptomycin (6 and 8 mg/kg of body weight), vancomycin, and gentamicin were simulated."( Short-course gentamicin in combination with daptomycin or vancomycin against Staphylococcus aureus in an in vitro pharmacodynamic model with simulated endocardial vegetations.
Rybak, MJ; Tsuji, BT, 2005
)
0.33
"To report a case in which vancomycin clearance was used to determine the daptomycin dosing interval in a morbidly obese patient with renal impairment."( Using vancomycin concentrations for dosing daptomycin in a morbidly obese patient with renal insufficiency.
Allen, SE; Mercier, RC; Pai, MP, 2006
)
0.33
" Daptomycin was administered empirically at 6 mg/kg dosed every 48 hours based on estimated clearance from measured vancomycin concentrations."( Using vancomycin concentrations for dosing daptomycin in a morbidly obese patient with renal insufficiency.
Allen, SE; Mercier, RC; Pai, MP, 2006
)
0.33
"The dosing interval of daptomycin is adjusted based on Cl(cr)."( Using vancomycin concentrations for dosing daptomycin in a morbidly obese patient with renal insufficiency.
Allen, SE; Mercier, RC; Pai, MP, 2006
)
0.33
"In this clinical scenario, vancomycin concentrations more accurately estimated Cl(cr), thereby facilitating determination of the daptomycin dosing interval."( Using vancomycin concentrations for dosing daptomycin in a morbidly obese patient with renal insufficiency.
Allen, SE; Mercier, RC; Pai, MP, 2006
)
0.33
" These age-related differences in the pharmacokinetic profile of daptomycin have significant dosing implications."( Pharmacokinetics of daptomycin in a critically ill adolescent with vancomycin-resistant enterococcal endocarditis.
Akins, RL; Haase, MR; Levy, EN, 2006
)
0.33
" Daptomycin was well tolerated in subjects dosed with up to 12 mg/kg intravenously for 14 days."( Pharmacokinetics and tolerability of daptomycin at doses up to 12 milligrams per kilogram of body weight once daily in healthy volunteers.
Benvenuto, M; Benziger, DP; Vigliani, G; Yankelev, S, 2006
)
0.33
" Enhancement of bactericidal activity was evaluated by calculating and comparing the areas under the bactericidal curve (AUBC) for each dosing regimen against each isolate."( Serum bactericidal activities of high-dose daptomycin with and without coadministration of gentamicin against isolates of Staphylococcus aureus and Enterococcus species.
DeRyke, CA; Kuti, JL; Nicolau, DP; Sutherland, C; Zhang, B, 2006
)
0.33
"Pharmacotherapy in critically ill patients receiving continuous renal replacement therapies (CRRT) is challenging due to the lack of published information to base dosing regimens."( Daptomycin clearance during modeled continuous renal replacement therapy.
Churchwell, MD; Mueller, BA; Pasko, DA, 2006
)
0.33
"Dalbavancin, a semisynthetic lipoglycopeptide being developed for the treatment of skin and skin structure infections (SSSIs), has a half-life of 5 to 7 days in humans and offers promise for a convenient weekly dosing regimen."( Bactericidal activity and resistance development profiling of dalbavancin.
Draghi, DC; Goldstein, BP; Hogan, P; Sahm, DF; Sheehan, DJ, 2007
)
0.34
"Given the limitations of this registry (which include its retrospective nature; limited numbers of MSSA patients; and lack of specific information on adverse events, type and duration of prior antibiotic therapy, timing and duration of concomitant antibiotic therapy, concomitant surgical interventions, and possible on-therapy dosing adjustments), daptomycin appeared effective in postmarketing clinical practice in the treatment of cSSSI caused by MRSA and MSSA."( Efficacy of daptomycin in complicated skin and skin-structure infections due to methicillin-sensitive and -resistant Staphylococcus aureus: results from the CORE Registry.
Lamp, KC; Martone, WJ, 2006
)
0.33
" It has very good pharmacokinetics properties with a long half-life which allows a single intravenous daily dose and is currently approved for treatment of complicated skin and soft tissue infections at the dosage of 4 mg/kg/die and for treatment of bacteremia and endocarditis at the dosage of 6 mg/kg/die."( [Daptomycin, the first cydal antibiotic of a new class active against Gram positive pathogens].
Esposito, S; Stefani, S, 2006
)
0.33
" We attempted to determine if this occurrence was reproducible in vitro and if it could be prevented by various daptomycin dosing strategies."( Evaluation of daptomycin treatment of Staphylococcus aureus bacterial endocarditis: an in vitro and in vivo simulation using historical and current dosing strategies.
Kaatz, GW; Rose, WE; Rybak, MJ, 2007
)
0.34
" Bactericidal activity was noted with 6 and 10 mg/kg dosing against SA-675 with no resistance detected."( Evaluation of daptomycin treatment of Staphylococcus aureus bacterial endocarditis: an in vitro and in vivo simulation using historical and current dosing strategies.
Kaatz, GW; Rose, WE; Rybak, MJ, 2007
)
0.34
"The emergence of resistance was successfully recreated at suboptimal dosing regimens while the current recommended regimen of 6 mg/kg/day prevented the emergence of non-susceptible mutants."( Evaluation of daptomycin treatment of Staphylococcus aureus bacterial endocarditis: an in vitro and in vivo simulation using historical and current dosing strategies.
Kaatz, GW; Rose, WE; Rybak, MJ, 2007
)
0.34
"The present study characterized the single-dose pharmacokinetics of daptomycin dosed as 4 mg/kg of total body weight (TBW) in seven morbidly obese and seven age-, sex-, race-, and serum creatinine-matched healthy subjects."( Influence of morbid obesity on the single-dose pharmacokinetics of daptomycin.
Anderson, T; Goade, DW; Mercier, RC; Norenberg, JP; Pai, MP; Rodvold, KA; Telepak, RA, 2007
)
0.34
" It is a safe and well-tolerated antibiotic, particularly at the current dosing regimen."( Daptomycin.
Bygott, JM; Daly, ML; Enoch, DA; Karas, JA, 2007
)
0.34
" The positive outcome in our patient is likely attributable to aggressive vancomycin dosing and extended duration of treatment prior to the initiation of daptomycin."( Daptomycin use after vancomycin-induced neutropenia in a patient with left-sided endocarditis.
Mergenhagen, KA; Pasko, MT, 2007
)
0.34
" The pharmacokinetic and pharmacodynamic properties of daptomycin allow for once-daily dosing, although it is recommended that the dosing interval be increased to 2 days in patients with renal impairment."( Daptomycin in the treatment of skin, soft-tissue and invasive infections due to Gram-positive bacteria.
Johnson, A, 2006
)
0.33
" It has rapid bactericidal activity against growing and stationary-phase bacteria, once-daily dosing regimen, and has a low potential for the development of resistance."( Daptomycin and tigecycline: a review of clinical efficacy in the antimicrobial era.
Ziglam, H, 2007
)
0.34
" Daptomycin should be administered intravenously once daily, because adverse effects on skeletal muscle associated with an increase in plasma levels of creatine phosphokinase and myopathy were observed more frequently at shorter dosing intervals."( Daptomycin: a review 4 years after first approval.
Graninger, W; Joukhadar, C; Rothenburger, M; Sauermann, R, 2008
)
0.35
" Historical controls received at least 3 days of vancomycin dosed to achieve trough concentrations of 5-20 microg/ml."( Daptomycin versus vancomycin for complicated skin and skin structure infections: clinical and economic outcomes.
Davis, SL; Delgado, G; Hall, LM; McKinnon, PS; Rose, W; Rybak, MJ; Wilson, RF, 2007
)
0.34
" The patient did not respond to 5 days of appropriately dosed linezolid and daptomycin and remained bacteremic because abscess drainage was not an option in this case and the continuous, high-grade MRSA bacteremia continued despite appropriate therapy."( Methicillin-resistant Staphylococcus aureus (MRSA) mitral valve acute bacterial endocarditis (ABE) in a patient with Job's syndrome (hyperimmunoglobulin E syndrome) successfully treated with linezolid and high-dose daptomycin.
Cunha, BA; Kodali, V; Krol, V,
)
0.13
" Even though the infants received higher doses than adults, their drug concentrations were comparable to those observed in adults treated with regular dosing of daptomycin."( Daptomycin use in infants: report of two cases with peak and trough drug concentrations.
Benjamin, DK; Cohen-Wolkowiez, M; Fowler, VG; Smith, PB; Wade, KC, 2008
)
0.35
"The need to investigate novel dosing regimens and combinations is essential in combating poor treatment outcomes for Staphylococcus aureus bacteremia and endocarditis."( Evaluation of daptomycin pharmacodynamics and resistance at various dosage regimens against Staphylococcus aureus isolates with reduced susceptibilities to daptomycin in an in vitro pharmacodynamic model with simulated endocardial vegetations.
Leonard, SN; Rose, WE; Rybak, MJ, 2008
)
0.35
" Moreover, these free, bioactive concentrations in tissue exceeded the MICs for staphylococci and streptococci over the 24-h dosing interval."( In vivo microdialysis study of the penetration of daptomycin into soft tissues in diabetic versus healthy volunteers.
Gao, L; Kim, A; Kuti, JL; Nicolau, DP; Suecof, LA; Sutherland, CA, 2008
)
0.35
" Higher dosing at 6 mg/kg (with increased dosing interval in renal failure) should be considered in such patients as well as those at risk of bacteraemia, osteomyelitis, diabetic foot infection and in situations where there is more rapid drug clearance, such as infections complicating intravenous drug use and thermal burns."( Daptomycin: rationale and role in the management of skin and soft tissue infections.
Seaton, RA, 2008
)
0.35
" Continuous vancomycin infusion in the ITU setting guarantees optimal dosing for severely ill patients."( Are glycopeptides still appropriate and convenient for empiric use?
Gonzalez-Ruiz, A; Richardson, J, 2008
)
0.35
"This study demonstrated similarities between Taiwanese and Caucasian healthy subjects in the PK profiles of daptomycin, and thus the dosage regimen used in Caucasian subjects could be applied to Taiwanese."( Pharmacokinetics and safety of multiple intravenous doses of daptomycin in a Taiwanese adult population.
Chang, SC; Huang, YT; Liang, SH; Sheng, WH; Wu, FL, 2009
)
0.35
" Additional studies of dosing and pharmacokinetics of intraperitoneal daptomycin in the treatment of patients with vancomycin-resistant enterococcus peritonitis are needed."( Successful use of intraperitoneal daptomycin in the treatment of vancomycin-resistant enterococcus peritonitis.
Abu-Alfa, AK; Brewster, UC; Hall, I; Huen, SC; Mahnensmith, RL; Topal, J, 2009
)
0.35
"Knowledge on the elimination of antibiotics by extracorporeal hemofiltration is a prerequisite for appropriate antimicrobial dosing in patients with renal failure."( Daptomycin elimination by CVVH in vitro: evaluation of factors influencing sieving and membrane adsorption.
Steiner, I; Wagner, CC; Zeitlinger, M, 2009
)
0.35
" Advantages such as superior volume control, excellent metabolic control, and hemodynamic tolerance by critically ill patients are well documented, but an understanding of drug dosing for CRRT is still a bit of a mystery."( Drug dosing during continuous renal replacement therapy.
Churchwell, MD; Mueller, BA,
)
0.13
" This study determined the pharmacokinetics of intradialytically dosed daptomycin in patients with ESRD."( Intradialytic administration of daptomycin in end stage renal disease patients on hemodialysis.
Churchwell, MD; Gao, L; Heung, M; Mueller, BA; Patel, JH; Salama, NN; Segal, JH, 2009
)
0.35
" The recommended dosing regimen would conflict with asymmetric thrice-weekly haemodialysis, which yields two ~44-hr and one ~68-hr interdialytic periods."( Single-dose daptomycin pharmacokinetics in chronic haemodialysis patients.
Churchwell, MD; Gao, L; Heung, M; Mueller, BA; Patel, JH; Salama, NN; Segal, JH, 2010
)
0.36
" Currently, no dosing recommendations exist for this drug for patients with acute kidney injury (AKI) undergoing renal replacement therapy."( Dosing of daptomycin in intensive care unit patients with acute kidney injury undergoing extended dialysis--a pharmacokinetic study.
Bode-Boeger, SM; Burkhardt, O; Eugbers, C; Hafer, C; Haller, H; Joukhadar, C; Kielstein, JT; Knitsch, W; Martens-Lobenhoffer, J; Traunmüller, F, 2010
)
0.36
"3 m(2); blood and dialysate flow, 160 ml/min; ED time, 480 min) and employing current dosing regimen, 6 mg/kg daptomycin every 48 h, run the risk of becoming significantly under dosed if one adheres to a twice daily dosing schedule that is recommended for patients on maintenance haemodialysis."( Dosing of daptomycin in intensive care unit patients with acute kidney injury undergoing extended dialysis--a pharmacokinetic study.
Bode-Boeger, SM; Burkhardt, O; Eugbers, C; Hafer, C; Haller, H; Joukhadar, C; Kielstein, JT; Knitsch, W; Martens-Lobenhoffer, J; Traunmüller, F, 2010
)
0.36
" However, daptomycin dosing and its ability to penetrate into inflamed target tissues are still a matter of controversy."( Soft tissue and bone penetration abilities of daptomycin in diabetic patients with bacterial foot infections.
Joukhadar, C; Konz, KH; Mauric, O; Metzler, J; Popovic, M; Scharnagl, E; Schintler, MV; Spendel, S; Traunmüller, F, 2010
)
0.36
" In all subjects, daptomycin was administered intravenously once daily at a dosage of 6 mg/kg body weight for 4 consecutive days at minimum."( Soft tissue and bone penetration abilities of daptomycin in diabetic patients with bacterial foot infections.
Joukhadar, C; Konz, KH; Mauric, O; Metzler, J; Popovic, M; Scharnagl, E; Schintler, MV; Spendel, S; Traunmüller, F, 2010
)
0.36
" Nearly 70% of the respondent hospitals reported having a vancomycinspecific dosing or monitoring guideline in place."( Hospital policies and practices on prevention and treatment of infections caused by methicillin-resistant Staphylococcus aureus.
Hennenfent, J; Lambert, BL; McBride, MV; Rodvold, KA; Schiff, G; Schumock, GT; Trese, AM; Tverdek, F; Yang, Y, 2010
)
0.36
" The use of higher doses and less-frequent dosing of existing agents is being explored, and exciting new developments include the emergence of agents with broader-spectrum activity against drug-resistant organisms and the use of antifungal agents in the OPAT setting."( Outpatient parenteral antimicrobial therapy: Recent developments and future prospects.
Chapman, AL; Lessing, MP; Sanderson, F; Seaton, RA; Török, ME, 2010
)
0.36
" Further investigation into β-lactam dosing strategies against different BORSA strains is warranted in order to avoid possible therapy failure."( Diminished in vitro antibacterial activity of oxacillin against clinical isolates of borderline oxacillin-resistant Staphylococcus aureus.
Beisser, PS; Croes, S; Deurenberg, RH; Neef, C; Stobberingh, EE; Terporten, PH, 2010
)
0.36
"To investigate daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis to develop dosing recommendations."( Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis.
Depestel, DD; Gao, L; Grio, M; Heung, M; Mueller, BA; Salama, NN; Sowinski, KM; Vilay, AM, 2011
)
0.37
" For a successful therapy it is of vital importance that these compounds are used judiciously and dosed appropriately."( Comparison of the pharmacokinetic properties of vancomycin, linezolid, tigecyclin, and daptomycin.
Derendorf, H; Estes, KS, 2010
)
0.36
"The pharmacokinetics of daptomycin 6 mg/kg support a dosing regimen of every 48 h in CAPD and thrice-weekly dosing in HD."( Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis.
Benziger, DP; Cannon, C; Donovan, J; Pertel, PE; Schwab, RJ; Swan, SK; Yankelev, S, 2011
)
0.37
"To address issues of antibiotic dosing during sustained low-efficiency dialysis by using available pharmacokinetic data, intermittent and continuous renal replacement therapy dialysis guidelines, and our experience with sustained low-efficiency dialysis."( Antibiotic dosing during sustained low-efficiency dialysis: special considerations in adult critically ill patients.
Bogard, KN; Erwin, MW; Fuller, PD; Olsen, KM; Peterson, NT; Plumb, TJ, 2011
)
0.37
"Published clinical trials, case reports, and reviews of antibiotic dosing in humans during sustained low-efficiency dialysis."( Antibiotic dosing during sustained low-efficiency dialysis: special considerations in adult critically ill patients.
Bogard, KN; Erwin, MW; Fuller, PD; Olsen, KM; Peterson, NT; Plumb, TJ, 2011
)
0.37
" Appropriate dose and calculation of dosing intervals is essential to provide adequate antibiotic therapy in these patients."( Antibiotic dosing during sustained low-efficiency dialysis: special considerations in adult critically ill patients.
Bogard, KN; Erwin, MW; Fuller, PD; Olsen, KM; Peterson, NT; Plumb, TJ, 2011
)
0.37
"This study identified optimal daptomycin dosing for patients receiving thrice-weekly hemodialysis (HD)."( Use of pharmacokinetic and pharmacodynamic principles to determine optimal administration of daptomycin in patients receiving standardized thrice-weekly hemodialysis.
Cardone, K; Drusano, GL; Grabe, DW; Hoy, C; Lodise, TP; Manley, H; Meola, S; Patel, N, 2011
)
0.37
" Population PK modeling and Monte Carlo simulation (MCS) were used to identify CAPD dosing schemes providing efficacy and toxicity plasma profiles comparable with those obtained from MCS using the daptomycin population PK model derived from patients in the Staphylococcus aureus bacteremia-infective endocarditis (SAB-IE) study."( Pharmacokinetics and pharmacodynamics of intravenous daptomycin during continuous ambulatory peritoneal dialysis.
Cardone, KE; Drusano, GL; Grabe, DW; Hoy, CD; Lodise, TP; Manley, HJ; Meola, S; Patel, N, 2011
)
0.37
" daptomycin 4 or 6 mg/kg, depending on indication, every 48 h was identified as the optimal CAPD dosing scheme."( Pharmacokinetics and pharmacodynamics of intravenous daptomycin during continuous ambulatory peritoneal dialysis.
Cardone, KE; Drusano, GL; Grabe, DW; Hoy, CD; Lodise, TP; Manley, HJ; Meola, S; Patel, N, 2011
)
0.37
" CAPD dosing scheme."( Pharmacokinetics and pharmacodynamics of intravenous daptomycin during continuous ambulatory peritoneal dialysis.
Cardone, KE; Drusano, GL; Grabe, DW; Hoy, CD; Lodise, TP; Manley, HJ; Meola, S; Patel, N, 2011
)
0.37
" Overall, most indications and dosing regimens of daptomycin were within the health authorities' approved criteria, although the antibiotic was sometimes used for other clinical situations and at doses higher than those currently established."( [Clinical experience with daptomycin use in Spain. Global findings from EU-CORE database].
Almirante, B, 2010
)
0.36
" The recommended dosage in patients with previous renal impairment is 4 mg/kg/48 hours in SSTI."( [Safety of daptomycin in patients with renal impairment].
Azanza, JR; Quetglas, EG, 2010
)
0.36
" Currently, the daptomycin dosage is 4 mg/kg/day for treatment of complicated skin and soft-tissue infections and 6 mg/kg/day for Staphylococcus aureus bloodstream infections, including those with right-sided endocarditis, however higher doses (>6 mg/kg/day) have been explored as a possible alternative."( Daptomycin: evaluation of a high-dose treatment strategy.
Abraham, T; Balmir, E; Rapp, J; Saad, N; Vastey, F; Wu, G, 2011
)
0.37
"To determine the safety of daptomycin administered using a variety of doses and dosing frequencies in patients receiving intermittent hemodialysis who had probable or confirmed gram-positive infections."( Safety of daptomycin in patients receiving hemodialysis.
Crompton, JA; Donovan, BJ; Lamp, KC; Mueller, BA; Yankalev, S, 2011
)
0.37
" Of the 393 patients, 370 (94%) could be categorized by daptomycin dosing frequency: every 48 hours (251 patients [64%]), 3 times/week (87 [22%]), and every 24 hours (32 [8%]); the remaining 23 (6%) had unreported dosing frequencies or received a single dose of daptomycin."( Safety of daptomycin in patients receiving hemodialysis.
Crompton, JA; Donovan, BJ; Lamp, KC; Mueller, BA; Yankalev, S, 2011
)
0.37
"In these patients undergoing hemodialysis, daptomycin was a well-tolerated treatment for gram-positive infections across several doses and dosing frequencies."( Safety of daptomycin in patients receiving hemodialysis.
Crompton, JA; Donovan, BJ; Lamp, KC; Mueller, BA; Yankalev, S, 2011
)
0.37
"The dosing regimen of 4 mg/kg TBW of daptomycin administered to CVVHD patients every 48 h is inappropriate to achieve effective antimicrobial plasma concentrations of daptomycin in the second half of the dosing interval (24 - 48 h)."( Plasma pharmacokinetics of daptomycin in critically ill patients with renal failure and undergoing CVVHD.
Eggers, K; Joukhadar, C; Khadzhynov, D; König, T; Lieker, I; Neumayer, HH; Peters, H; Puhlmann, B; Slowinski, T; Spies, C; Traunmüller, F; Uhrig, A, 2011
)
0.37
" This study was performed to develop dosing recommendations in continuous venovenous haemodiafiltration (CVVHDF)."( Multiple-dose pharmacokinetics of daptomycin during continuous venovenous haemodiafiltration.
Dittrich, P; Fuhrmann, V; Meyer, B; Saria, K; Thalhammer, F; Wenisch, JM; Zuba, C, 2012
)
0.38
"Limited data are available on the pharmacokinetics and optimal dosage of daptomycin, a lipopeptide compound possessing activity against Gram-positive bacteria, in the pediatric population, particularly in neonates and infants."( Serum levels of daptomycin in pediatric patients.
Antachopoulos, C; Bazoti, F; Drossou-Agakidou, V; Gikas, E; Iosifidis, E; Katragkou, A; Roilides, E; Sarafidis, K, 2012
)
0.38
" A dosage of 6 mg/kg/12 h of daptomycin to the infants resulted in trough concentrations of <4-8."( Serum levels of daptomycin in pediatric patients.
Antachopoulos, C; Bazoti, F; Drossou-Agakidou, V; Gikas, E; Iosifidis, E; Katragkou, A; Roilides, E; Sarafidis, K, 2012
)
0.38
"A dosage of daptomycin 6 mg/kg/12 h in small infants results in lower peak and similar trough concentrations compared with a dosage of 4 mg/kg/day administered to adults."( Serum levels of daptomycin in pediatric patients.
Antachopoulos, C; Bazoti, F; Drossou-Agakidou, V; Gikas, E; Iosifidis, E; Katragkou, A; Roilides, E; Sarafidis, K, 2012
)
0.38
" In this mouse model of surgical implant MSSA or MRSA infection, daptomycin and tigecycline prophylaxis were effective over a broader dosage range than vancomycin."( Daptomycin and tigecycline have broader effective dose ranges than vancomycin as prophylaxis against a Staphylococcus aureus surgical implant infection in mice.
Billi, F; Francis, KP; Miller, LS; Niska, JA; Pribaz, JR; Ramos, RI; Shahbazian, JH, 2012
)
0.38
" Pharmacokinetic studies and data from the CORE Registry have allowed improved the dosing regimen in patients under hemodialysis, peritoneal dialysis and other extrarenal depuration techniques."( [Daptomycin in the treatment of Gram-positive infections in patients with chronic renal failure].
Sarriá Cepeda, C, 2012
)
0.38
"The impact of an institutional protocol intended to improve daptomycin dosing for vancomycin-resistant enterococci (VRE) infections was investigated."( Evaluation of a daptomycin dose-optimization protocol.
Cottreau, J; Garey, KW; Hirsch, EB; Palmer, HR; Shah, DN; Tam, VH; Tran, TT; Weston, J, 2012
)
0.38
" As part of an initiative to optimize daptomycin dosing for all indications and regimens, a large medical center implemented a protocol restricting daptomycin prescribing to infectious-diseases specialists and a nomogram recommending elevated daptomycin dosing for all VRE infections, with baseline and weekly creatinine phosphokinase (CPK) determinations during daptomycin therapy."( Evaluation of a daptomycin dose-optimization protocol.
Cottreau, J; Garey, KW; Hirsch, EB; Palmer, HR; Shah, DN; Tam, VH; Tran, TT; Weston, J, 2012
)
0.38
"Implementation of a daptomycin dosing protocol by a multidisciplinary antimicrobial stewardship team optimized treatment by increasing the mean dose of daptomycin administered to hospitalized adults with non-urinary VRE infections and improved the rate of safety monitoring."( Evaluation of a daptomycin dose-optimization protocol.
Cottreau, J; Garey, KW; Hirsch, EB; Palmer, HR; Shah, DN; Tam, VH; Tran, TT; Weston, J, 2012
)
0.38
"For critically ill patients undergoing continuous renal replacement therapy (CRRT), daptomycin dosing recommendations are scarce."( Experience with daptomycin daily dosing in ICU patients undergoing continuous renal replacement therapy.
Corti, N; Fehr, J; Preiswerk, B; Rudiger, A, 2013
)
0.39
" Peak and trough concentrations showed a high intra- and inter-patient variability in both groups, independent of the dosage per kg body weight."( Experience with daptomycin daily dosing in ICU patients undergoing continuous renal replacement therapy.
Corti, N; Fehr, J; Preiswerk, B; Rudiger, A, 2013
)
0.39
"In critically ill patients undergoing CRRT, daptomycin exposure with once-daily dosing was similar to ICU patients with normal renal function, but lower compared to healthy volunteers."( Experience with daptomycin daily dosing in ICU patients undergoing continuous renal replacement therapy.
Corti, N; Fehr, J; Preiswerk, B; Rudiger, A, 2013
)
0.39
" The aggressive vancomycin dosing regimens are still associated with unacceptable high microbiological failure rates and it is not currently possible to achieve probability of target attainment at higher vancomycin MICs of 2 mg/l."( Does resistance in severe infections caused by methicillin-resistant Staphylococcus aureus give you the 'creeps'?
Brink, AJ, 2012
)
0.38
"Continued monitoring of patients on aggressive vancomycin dosing schedules is advised."( Does resistance in severe infections caused by methicillin-resistant Staphylococcus aureus give you the 'creeps'?
Brink, AJ, 2012
)
0.38
"While the pharmacokinetic (PK) properties of daptomycin in hemodialysis (HD) patients have been evaluated previously by three groups, resultant dosing recommendations have varied."( Daptomycin pharmacokinetics and pharmacodynamics in a pooled sample of patients receiving thrice-weekly hemodialysis.
Butterfield, JM; Cardone, KE; Grabe, DW; Lodise, TP; Mueller, BA; Patel, N; Salama, NN, 2013
)
0.39
" Dose-response data were analyzed by a maximum effect (E(max)) model using nonlinear regression."( Inoculum effects of ceftobiprole, daptomycin, linezolid, and vancomycin with Staphylococcus aureus and Streptococcus pneumoniae at inocula of 10(5) and 10(7) CFU injected into opposite thighs of neutropenic mice.
Andes, DR; Craig, WA; Lee, DG; Murakami, Y, 2013
)
0.39
" Patients receiving a daptomycin dosage of 8 mg/kg/day had significantly higher values of mean C max and AUC0-24."( Variability of pharmacokinetic parameters in patients receiving different dosages of daptomycin: is therapeutic drug monitoring necessary?
Cassetta, MI; d'Ettorre, G; Falcone, M; Fallani, S; Lappa, A; Novelli, A; Russo, A; Tritapepe, L; Venditti, M, 2013
)
0.39
"Increasing the dosage of daptomycin may be advantageous in severe infection by enhancing bactericidal activity and pharmacodynamics."( Safety and efficacy of high-dose daptomycin as salvage therapy for severe gram-positive bacterial sepsis in hospitalized adult patients.
Chang, SC; Chen, YC; Cheng, A; Chuang, YC; Lai, CC; Sheng, WH; Wang, JT, 2013
)
0.39
" A combination of daptomycin plus trimethoprim/sulfamethoxazole (TMP/SMX) was administered for six weeks, followed by a high dosage of TMP/SMX for a further six weeks."( High dose of trimethoprim-sulfamethoxazole and daptomycin as a therapeutic option for MRSA endocarditis with large vegetation complicated by embolic stroke: a case report and literature review.
Bonura, C; D'Alessandro, N; Di Carlo, P; Giarratano, A; Guadagnino, G; Lunetta, M; Mammina, C; Novo, S, 2013
)
0.39
" aureus (VSSA) JKD6009 to simulated human vancomycin dosing regimens (500 mg to 4,000 mg every 12 h) using a 10-day hollow fiber infection model."( Decreased vancomycin susceptibility in Staphylococcus aureus caused by IS256 tempering of WalKR expression.
Doig, K; Gao, W; Howden, BP; McEvoy, CR; Ngo, D; Porter, JL; Seemann, T; Stinear, TP; Tsuji, B, 2013
)
0.39
"A total of 126 hospitalized adult obese patients (body mass index [BMI] more than 30 kg/m(2) ) admitted from January 2005 through May 2010 who received daptomycin dosed on actual body weight for any indication for a minimum of 7 days."( Safety and effectiveness of daptomycin across a hospitalized obese population: results of a multicenter investigation in the southeastern United States.
Bland, CM; Bookstaver, PB; Caulder, CR; Faulkner-Fennell, CM; Hartis, C; Qureshi, ZP; Sheldon, MA, 2013
)
0.39
" Daptomycin was generally administered at a planned dosage regimen of ≥ 5 mg/kg every 24 hours in patients with normal to moderately impaired kidney function or every 48 hours in patients with severe kidney disease."( Use of daptomycin in the treatment of vancomycin-resistant enterococcal urinary tract infections: a short case series.
Amodio-Groton, M; Ramaswamy, DP; Scholand, SJ, 2013
)
0.39
"We describe the case of an intravenous drug user affected by life-threatening Staphylococcus aureus-complicated skin and soft tissue infection with associated bacteraemia who, while on replacement therapy with methadone, required 11 mg/kg/day daptomycin to achieve trough (Cmin) and peak (Cmax) plasma levels similar to those observed with the standard dosage of 6 mg/kg in healthy volunteers (mean ± standard deviation: Cmin 12."( Daptomycin underexposure in a young intravenous drug user who was affected by life-threatening Staphylococcus aureus-complicated skin and soft tissue infection associated with bacteraemia.
Bassetti, M; Cojutti, P; Crapis, M; Pea, F, 2014
)
0.4
"To support daptomycin dosing recommendations in patients with Staphylococcus aureus bacteraemia (SAB) and severe renal impairment using simulations from a population pharmacokinetic model for daptomycin."( Clinical and pharmacokinetic considerations for the use of daptomycin in patients with Staphylococcus aureus bacteraemia and severe renal impairment.
Benziger, D; Chakraborty, A; Chaves, RL; Tannenbaum, S, 2014
)
0.4
" Daptomycin 24 h AUC and Cmax were then simulated for subjects with a CL(CR) < 30 mL/min [with or without haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD)] for different dosing frequencies (every 24 h, every 48 h and three times weekly) with doses of 4 mg/kg and 6 mg/kg."( Clinical and pharmacokinetic considerations for the use of daptomycin in patients with Staphylococcus aureus bacteraemia and severe renal impairment.
Benziger, D; Chakraborty, A; Chaves, RL; Tannenbaum, S, 2014
)
0.4
" Daptomycin concentrations were measured intensively over the initial 96-hour dosing period."( Considerations for higher doses of daptomycin in critically ill patients with methicillin-resistant Staphylococcus aureus bacteremia.
Falcone, M; Novelli, A; Pai, MP; Russo, A; Venditti, M, 2013
)
0.39
"A reappraisal of current daptomycin dosing recommendations is needed to improve the PTA and reduce toxicity among critically ill patients."( Considerations for higher doses of daptomycin in critically ill patients with methicillin-resistant Staphylococcus aureus bacteremia.
Falcone, M; Novelli, A; Pai, MP; Russo, A; Venditti, M, 2013
)
0.39
"The optimal daptomycin dosing regimen for critically ill patients undergoing continuous renal replacement therapy (CRRT) has still to be established."( Pharmacokinetics of daily daptomycin in critically ill patients undergoing continuous renal replacement therapy.
Béchir, M; Chiesa, A; Corti, N; Jetter, A; Maggiorini, M; Marti, I; Müller, D; Rentsch, K; Rudiger, A, 2013
)
0.39
"Daptomycin use at our institution changed to ideal body weight dosing based on a published analysis of pharmacokinetic-pharmacodynamic efficacy target attainment, bacterial ecology, and a desire to reduce drug toxicity."( Daptomycin dosing based on ideal body weight versus actual body weight: comparison of clinical outcomes.
Andes, DR; Buhr, KA; Fish, JT; Fox, BC; Ng, JK; Rose, WE; Schulz, LT, 2014
)
0.4
"To determine the optimal dosing regimen of daptomycin in patients receiving thrice-weekly hemodialysis."( Daptomycin dosing strategies in patients receiving thrice-weekly intermittent hemodialysis.
Bohm, N; Haselden, M; Leach, M, 2013
)
0.39
" However, the daptomycin prescribing information recommends dosing every 48 hours in patients receiving hemodialysis, which results in dyssynchrony of dosing and dialysis sessions every other week."( Daptomycin dosing strategies in patients receiving thrice-weekly intermittent hemodialysis.
Bohm, N; Haselden, M; Leach, M, 2013
)
0.39
" Discontinuation of therapy because of elevated CPK levels may have been avoided in some patients with adjustment to every 48-hour dosing for Clcr less than 30 ml/minute."( Efficacy and safety of daptomycin in patients with renal impairment: a multicenter retrospective analysis.
Geriak, M; Kullar, R; McClellan, I; Sakoulas, G, 2014
)
0.4
"5 h and 3 h and Ct in 15-min increments within an hour of the end of the dosing interval for each dose."( Simplified equations using two concentrations to calculate area under the curve for antimicrobials with concentration-dependent pharmacodynamics: daptomycin as a motivating example.
Falcone, M; Novelli, A; Pai, MP; Russo, A; Venditti, M, 2014
)
0.4
"A case series in which a novel dosing strategy for managing mild, asymptomatic creatine kinase (CK) increases associated with daptomycin therapy is presented."( Dosing strategy to allow continued therapy with daptomycin after asymptomatic increases in creatine kinase levels.
Benziger, D; Burdette, SD; McDaneld, PM; Oleson, F; Patel, HN, 2014
)
0.4
"Daptomycin is used off-label for enterococcal infections; however, dosing targets for resistance prevention remain undefined."( Defining daptomycin resistance prevention exposures in vancomycin-resistant Enterococcus faecium and E. faecalis.
Arias, CA; Ireland, CE; Murray, BE; Nonejuie, P; Pogliano, J; Rose, WE; Rybak, MJ; Sakoulas, G; Steed, ME; Tran, TT; Werth, BJ, 2014
)
0.4
" We planned for rapid load and CSF sterilization and extended the dosing interval once drug accumulation was expected to have occurred."( Successful treatment of ventriculostomy-associated meningitis caused by multidrug resistant coagulase-negative Staphylococcus epidermidis using low-volume intrathecal daptomycin and loading strategy.
Denetclaw, TH; Suehiro, I; Tolliver, GL; Wang, PK, 2014
)
0.4
"IT daptomycin 5 mg diluted to 3 mL in NS and dosed in a loading strategy was effective and without adverse sequelae."( Successful treatment of ventriculostomy-associated meningitis caused by multidrug resistant coagulase-negative Staphylococcus epidermidis using low-volume intrathecal daptomycin and loading strategy.
Denetclaw, TH; Suehiro, I; Tolliver, GL; Wang, PK, 2014
)
0.4
" The main objective of this review is to compare the relative efficacies, dosing strategies, and side-effect profiles of quinupristin-dalfopristin, linezolid, and daptomycin for VRE bacteremia in the pediatric population."( Optimizing therapy for vancomycin-resistant enterococcal bacteremia in children.
Hsu, AJ; Tamma, PD, 2014
)
0.4
" Daptomycin exposures based on mg/kg dosing were lower than previously reported for older children and adults, likely because of increased clearance and volume of distribution and decreased apparent elimination half-life."( Single-dose pharmacokinetics of daptomycin in pediatric patients 3-24 months of age.
Benziger, D; Bokesch, P; Bradley, JS; Jacobs, R, 2014
)
0.4
" The data collected in adults can only be transferred to children older than 12 years, and the information available is not sufficient to determine the dosage that will assure the highest antimicrobial efficacy with only marginal risks of adverse events in younger patients."( Daptomycin in paediatrics: current knowledge and the need for future research.
Caironi, M; Esposito, S; Pani, L; Principi, N; Venturini, F, 2015
)
0.42
" With a further dosage reduction and continued administration of sodium polystyrene sulfonate, the patient completed the full course of daptomycin therapy."( Daptomycin-induced hyperkalemia in a patient with normal renal function.
Berger, B; Blum, S; Budovich, A, 2014
)
0.4
" Finally, we examined the ability of pulse dosing an antibiotic to eliminate persisters."( Borrelia burgdorferi, the Causative Agent of Lyme Disease, Forms Drug-Tolerant Persister Cells.
Brown, AV; Hu, LT; Lewis, K; Matluck, NE; Sharma, B, 2015
)
0.42
" In conclusion, no clear correlation between PK/PD indices and the probability of efficacy or safety events was demonstrated when daptomycin was administered in SSTI patients using the clinically recommended dosage of 4 mg/kg/day."( Correlation between pharmacokinetic/pharmacodynamic indices and clinical outcomes in Japanese patients with skin and soft tissue infections treated with daptomycin: analysis of a phase III study.
Aikawa, N; Ishii, M; Kusachi, S; Mikamo, H; Takahashi, K; Takesue, Y; Watanabe, S; Yoshinari, T, 2015
)
0.42
"We aimed to characterize real-world dosing of weight-based intravenous (IV) antibiotic therapy in patients hospitalized for methicillin-resistant Staphylococcus aureus (MRSA) complicated skin and soft-tissue infections (cSSTIs)."( Weight-based antibiotic dosing in a real-world European study of complicated skin and soft-tissue infections due to methicillin-resistant Staphylococcus aureus.
Baillon-Plot, N; Charbonneau, C; Corman, S; Eckmann, C; Haider, S; Lawson, W; Li, J; Macahilig, C; Nathwani, D; Solem, C; Stephens, J, 2015
)
0.42
"We report our clinical experience with the use of daptomycin, administered in the dosage of 8 mg/kg/d in 3 minutes, in treating 12 critically ill children younger than 12 years, with bloodstream infections (n = 9) and complicated skin and soft-tissue infections (n = 3)."( Use of Daptomycin in Critically Ill Children With Bloodstream Infections and Complicated Skin and Soft-tissue Infections.
Conti, M; Giannella, M; Tedeschi, S; Tumietto, F; Viale, P, 2016
)
0.43
" Considering the analysis of daptomycin in a pharmaceutical dosage form, the only method found in literature uses potentially toxic organic solvents."( Development, Optimization, and Validation of a Green and Stability-Indicating HPLC Method for Determination of Daptomycin in Lyophilized Powder.
Salgado, HR; Tótoli, EG,
)
0.13
" Daptomycin, as first-line therapy for the treatment of severe MRSA infections, should be used at optimal dosage combined with other agents such as beta-lactams, to prevent daptomycin resistance occurrence."( In vivo development of daptomycin resistance in vancomycin-susceptible methicillin-resistant Staphylococcus aureus severe infections previously treated with glycopeptides.
Cafiso, V; Campanile, F; Capone, A; Mariani, B; Parisi, G; Petrosillo, N; Stefani, S, 2016
)
0.43
" The mean dosage was 9 mg/kg/day (5-11 mg/kg/day) for a mean duration of 11 days (2; 55 days)."( Study on daptomycin use and implementation of an antimicrobial stewardship program.
Castel, C; Cattoir, V; de La Blanchardière, A; Michon, J; Saint-Lorant, G, 2016
)
0.43
"Faced with a lack of recent recommendations on the subject, our multidisciplinary team issued a local consensus, defining the indications and dosage modalities for this reserve antibiotic."( Study on daptomycin use and implementation of an antimicrobial stewardship program.
Castel, C; Cattoir, V; de La Blanchardière, A; Michon, J; Saint-Lorant, G, 2016
)
0.43
" She had acute kidney injury, requiring daptomycin dosage adjustment."( Successful Use of High-dose Daptomycin in a Child With Staphylococcus aureus Endocarditis.
Gnanasambandam, S; Kanjani, A; Nambi, PS; Prabhudesai, S; Ramachandran, B, 2016
)
0.43
" Appropriate antibiotic selection and adequate dosing are important for improving patient outcomes."( Daptomycin Pharmacokinetics and Pharmacodynamics in Septic and Critically Ill Patients.
Baietto, L; D'Avolio, A; De Rosa, FG; Di Perri, G; Pacini, G; Pensi, D, 2016
)
0.43
"Implementation of a standardized daptomycin dosing protocol in a community teaching hospital to determine potential cost savings, effectiveness, and safety is presented."( Evaluation of a standardized daptomycin dosing nomogram.
Maxwell, A; Schmidt, S; Sloan, A; Swindler, J, 2016
)
0.43
"Implementation of a standardized dosing nomogram reduced the amount of daptomycin wasted and resulted in cost savings."( Evaluation of a standardized daptomycin dosing nomogram.
Maxwell, A; Schmidt, S; Sloan, A; Swindler, J, 2016
)
0.43
"5 mg/L when using a dosage from 4 to 12 mg/kg."( Mutant prevention concentrations of daptomycin for Enterococcus faecium clinical isolates.
Auzou, M; Cattoir, V; Giard, JC; Jaussaud, C; Sinel, C, 2016
)
0.43
"The objective of this population pharmacokinetic (PK) analysis was to provide guidance for the dosing interval of daptomycin in patients undergoing continuous renal replacement therapy (CRRT)."( Population pharmacokinetics of daptomycin in adult patients undergoing continuous renal replacement therapy.
Chaves, RL; Corti, N; Hamed, K; Khadzhynov, D; Levi, M; Peters, H; Xu, X, 2017
)
0.46
" One of two groups comprised patients received the loading dose of daptomycin on day 1 (group 1) and the other group received normal dosage (4-6 mg/kg/day) (group 2)."( Clinical effectiveness of daptomycin loading dose in patients infected with Gram-positive pathogens.
Hagihara, M; Kato, H; Koizumi, Y; Matsuura, K; Mikamo, H; Nishiyama, N; Yamagishi, Y, 2017
)
0.46
" Daptomycin was administered once daily with dosing by patient age: 12 to 17 years, 5 mg/kg; 7 to 11 years, 7 mg/kg; 2 to 6 years, 9 mg/kg; 12 to 23 months, 10 mg/kg."( Daptomycin for Complicated Skin Infections: A Randomized Trial.
Anastasiou, D; Arnold, SR; Arrieta, A; Bokesch, P; Bradley, J; Congeni, B; Daum, RS; Glasser, C; Kojaoghlanian, T; Patino, H; Wolf, DJ; Yoon, M, 2017
)
0.46
"73 m 2 and Alb 15-25 g/L, suboptimal PTAs (<60%) were predicted even with 12 mg/kg/day dosing ."( Population pharmacokinetics and dosing considerations for the use of daptomycin in adult patients with haematological malignancies.
Candoni, A; Cojutti, PG; Fanin, R; Hope, W; Lazzarotto, D; Pea, F; Ramos-Martin, V; Zannier, ME, 2017
)
0.46
" Daptomycin was dosed once daily by patient age: 12-17 years, 7 mg/kg; 7-11 years, 9 mg/kg and 1-6 years, 12 mg/kg."( Randomized Multicenter Study Comparing Safety and Efficacy of Daptomycin Versus Standard-of-care in Pediatric Patients With Staphylococcal Bacteremia.
Arrieta, AC; Bensaci, M; Bokesch, P; Bradley, JS; Du, L; Glasser, C; Grandhi, A; Kartsonis, NA; Patino, H; Popejoy, MW, 2018
)
0.48
" Recent literature suggests that daptomycin, a cyclic lipopeptide antibiotic with concentration-dependent bactericidal activity, is the preferred treatment option for VRE bacteraemia, yet the optimal dosing strategy for this indication has not been established."( Association of daptomycin dosing regimen and mortality in patients with VRE bacteraemia: a review.
Aitken, SL; Arias, CA; Foolad, F; Shelburne, SA; Taylor, BD, 2018
)
0.48
" No adverse events were observed, but the toxicity of the 10 mg/kg q24h dosing regimen should be further assessed, particularly for patients with altered renal function."( Population pharmacokinetics of daptomycin in critically ill patients with various degrees of renal impairment.
Asehnoune, K; Barbaz, M; Couet, W; Ferrandière, M; Gaillard, T; Grégoire, N; Lasocki, S; Launey, Y; Marchand, S; Mimoz, O; Seguin, P; Vourc'h, M, 2019
)
0.51
" Simulations performed with the model showed that sex and P-gp haplotype may influence the PTA for high MIC values and that a dosage of 10 mg/kg/24 h would optimize efficacy."( Genetic polymorphisms of ABCB1 (P-glycoprotein) as a covariate influencing daptomycin pharmacokinetics: a population analysis in patients with bone and joint infection.
Becker, A; Bricca, R; Chidiac, C; Conrad, A; Ferry, T; Gagnieu, MC; Goutelle, S; Laurent, F; Roux, S; Triffault-Fillit, C; Valour, F, 2019
)
0.51
" Gender and P-gp gene polymorphism should be further examined as determinants of dosage requirements."( Genetic polymorphisms of ABCB1 (P-glycoprotein) as a covariate influencing daptomycin pharmacokinetics: a population analysis in patients with bone and joint infection.
Becker, A; Bricca, R; Chidiac, C; Conrad, A; Ferry, T; Gagnieu, MC; Goutelle, S; Laurent, F; Roux, S; Triffault-Fillit, C; Valour, F, 2019
)
0.51
"The objective of this study was to explore the optimal dosage regimen of daptomycin and to determine the necessity and validity of a high-dose regimen from the perspectives of PK/PD parameters using Monte Carlo Simulation (MCS) and therapeutic drug monitoring (TDM) in a Japanese clinical setting."( Clinical pharmacokinetic and pharmacodynamic analysis of daptomycin and the necessity of high-dose regimen in Japanese adult patients.
Aoki, Y; Hamada, Y; Magarifuchi, H; Oka, Y; Okinaka, T; Urakami, T; Yamakuchi, H, 2019
)
0.51
" At an initially recommended dosage of 6mg/kg, bone concentrations are likely to be effective against staphylococcal infections and infections due to low-MIC Enterococcus."( Bone penetration of daptomycin in diabetic patients with bacterial foot infections.
Argemi, X; Boeri, C; Gaudias, J; Grillon, A; Hansmann, Y; Jehl, F; Jenny, JY; Lefebvre, N; Ronde-Ousteau, C, 2019
)
0.51
" The side-effects of Daptomycin dosage through intravenous administration have prompted the experimental use of topical Daptomycin."( Oligodynamic Boons of Daptomycin and Noble Metal Nanoparticles Packaged in an Anti-MRSA Topical Gel Formulation.
Chakravarty, I; Kundu, S, 2019
)
0.51
" faecium, a susceptible dose-dependent (SDD) breakpoint of ≤4 μg/mL was established based on an increased dosage of 8-12 mg/kg/day (≥8 μg/mL-resistant)."( Development of Daptomycin Susceptibility Breakpoints for Enterococcus faecium and Revision of the Breakpoints for Other Enterococcal Species by the Clinical and Laboratory Standards Institute.
Campeau, SA; Humphries, RM; Jorgensen, JH; Kuti, JL; Lewis Ii, JS; Nicolau, DP; Satlin, MJ; Weinstein, MP, 2020
)
0.56
"In order to improve the stability of AgNPs and decrease the dosage of Daptomycin for killing bacteria, a reduced graphene oxide (rGO) was used for simultaneously anchoring AgNPs and Daptomycin to prepare rGO@Ag@Dap nanocomposites."( Daptomycin and AgNP co-loaded rGO nanocomposites for specific treatment of Gram-positive bacterial infection in vitro and in vivo.
Fan, J; Li, L; Liu, B; Liu, X; Tong, C; Wu, Z; Xiao, F; Zhong, X; Zhou, J, 2019
)
0.51
"The objective of this study was to evaluate the efficacy of various daptomycin dosing regimens against Staphylococcus aureus and Enterococcus faecium in pediatric patients with proven/suspected gram-positive infection."( Pharmacokinetic/Pharmacodynamic Analysis of Daptomycin Against Staphylococcus aureus and Enterococcus faecium in Pediatric Patients by Monte Carlo Simulation.
Li, X; Wei, XC; Xiao, X; Zhao, MF, 2020
)
0.56
"The dosing regimen of daptomycin for critically ill patients undergoing continuous renal replacement therapy (CRRT) remains controversial."( Population pharmacokinetics and dosing considerations of daptomycin in critically ill patients undergoing continuous renal replacement therapy.
Cheng, Z; Li, S; Xie, F, 2020
)
0.56
" Efficacy analysis demonstrated that q48h dosing is associated with an extremely low probability of bactericidal target attainment on every second day after dosing and q24h dosing is preferred for a high probability of bactericidal target attainment."( Population pharmacokinetics and dosing considerations of daptomycin in critically ill patients undergoing continuous renal replacement therapy.
Cheng, Z; Li, S; Xie, F, 2020
)
0.56
" Technical factors included investment in the optimization of dosing for improved drug exposure, toxicological evaluation of the purified eutomer from a diastereomer and the failure to develop an effective research formulation."( Decision making in the pharmaceutical industry - A tale of three antibiotics.
Hunt, A; Kirsch, DR, 2020
)
0.56
" Its elimination is mainly renal, with about 50% of the dose excreted unchanged in the urine, justifying dosage adjustment for patients with renal insufficiency."( Clinical Pharmacokinetics of Daptomycin.
Buyck, J; Chauzy, A; Couet, W; Gregoire, N; Marchand, S; Rammaert, B, 2021
)
0.62
"Daptomycin is increasingly used in the treatment of bone and joint infection (BJI), but its pharmacokinetics (PK) and dosage requirements have not been thoroughly investigated in this indication."( Population pharmacokinetics of daptomycin in patients with bone and joint infection: minimal effect of rifampicin co-administration and confirmation of a sex difference.
Bourguignon, L; Bricca, R; Conrad, A; Ferry, T; Gagnieu, MC; Garreau, R; Goutelle, S; Roux, S, 2021
)
0.62
"To investigate the population PK and dosage requirements of daptomycin in patients with BJI, and examine the influence of rifampicin co-administration."( Population pharmacokinetics of daptomycin in patients with bone and joint infection: minimal effect of rifampicin co-administration and confirmation of a sex difference.
Bourguignon, L; Bricca, R; Conrad, A; Ferry, T; Gagnieu, MC; Garreau, R; Goutelle, S; Roux, S, 2021
)
0.62
"A daptomycin dosage of 8 mg/kg/24 h in women and 10 mg/kg/24 h in men should optimize efficacy but may lead to excessive trough concentrations in many patients, especially in women."( Population pharmacokinetics of daptomycin in patients with bone and joint infection: minimal effect of rifampicin co-administration and confirmation of a sex difference.
Bourguignon, L; Bricca, R; Conrad, A; Ferry, T; Gagnieu, MC; Garreau, R; Goutelle, S; Roux, S, 2021
)
0.62
" Our results suggest that in clinical use of the tested antibiotics during CRRT with the ATA hemofilter, the same factors have to be considered for determining the dosing strategy as with filters with other commonly applied membrane materials."( Antibiotics Removal by Continuous Venovenous Hemofiltration with a Novel Asymmetric Triacetate Membrane Hemofilter: An in vitro Study.
Heskamp, B; Körtge, A; Majcher-Peszynska, J; Mitzner, S; Wasserkort, R, 2021
)
0.62
" To optimize vancomycin activity, dosage was adjusted to achieve an AUC/MIC ≥400."( Effectiveness of vancomycin plus cloxacillin compared with vancomycin, cloxacillin and daptomycin single therapies in the treatment of methicillin-resistant and methicillin-susceptible Staphylococcus aureus in a rabbit model of experimental endocarditis.
Almela, M; Cañas-Pacheco, MA; Castañeda, X; Dahl, A; Falces, C; Fuster, D; García-De-la-Mària, C; García-González, J; Gasch, O; Hernández-Meneses, M; Llopis, J; Marco, F; Miró, JM; Moreno, A; Pericàs, JM; Quintana, E; Soy, D; Tolosana, JM; Vidal, B, 2021
)
0.62
"The objective of this systematic review is to evaluate dosing regimens of combination salvage regimens used as part of infectious disease pharmacotherapy."( Dosing Considerations for Combination Antistaphylococcal β-Lactam and Glyco/lipopeptide Salvage Therapy for Resistant Gram-Positive Infections: A Systematic Review.
Brown, M; Ofori, R; Reinert, JP, 2022
)
0.72
" This work describes the heterogeneity of dosing regimens and seeks to define an optimal dose, duration, and combination of antibiotics."( Dosing Considerations for Combination Antistaphylococcal β-Lactam and Glyco/lipopeptide Salvage Therapy for Resistant Gram-Positive Infections: A Systematic Review.
Brown, M; Ofori, R; Reinert, JP, 2022
)
0.72
" Relative to 24 h controls, a dose-response in bacterial killing (range -0."( Efficacy assessment of lysin CF-296 in addition to daptomycin or vancomycin against Staphylococcus aureus in the murine thigh infection model.
Asempa, TE; Cassino, C; DeRosa, NA; Lehoux, D; Nicolau, DP; Schuch, R, 2021
)
0.62
" It also highlights the need for more research to identify optimal antimicrobial dosing strategies in similar scenarios."( A successful daptomycin and micafungin dosing strategy in veno-venous ECMO and continuous renal replacement.
Cabanilla, MG; Villalobos, N, 2022
)
0.72
" Twelve patients received daptomycin, and dosing information was recovered for 10."( Daptomycin susceptibility testing and therapeutic use in enterococcal bloodstream infection (EBSI) in a setting with high rates of vancomycin-resistant Enterococcus faecium (VREfm).
Dewar, S; Kelly, J; Tysall, L, 2022
)
0.72
"Use of daptomycin at doses ≥ 6 mg/kg for treatment of osteomyelitis is increasing in clinical practice; unfortunately, limited data are available to guide optimal dosing and duration."( Patterns of Care and Treatment Outcomes for Outpatient Daptomycin-Containing Regimens in Osteomyelitis.
Delate, T; Haghigatgoo, A; Nguyen, JK; Niu, F; Truong, JT, 2021
)
0.62
" Current guidelines recommend higher daptomycin doses (8-10 mg/kg) for severe infections; however, pharmacokinetic (PK) and pharmacodynamic-based dosing strategies are still limited."( Simplified daptomycin dosing regimen for adult patients with methicillin-resistant Staphylococcus aureus infections based on population pharmacokinetic analysis.
Egashira, N; Ieiri, I; Kitaichi, K; Maeshiro, Y; Miyake, N; Nishida, R; Oida, Y; Shimono, N; Soda, M; Yamada, T; Yamashita, Y, 2022
)
0.72
" Previous work showed that the approved dosage of daptomycin may be insufficient to achieve optimal exposure in patients with bone and joint infection."( Daptomycin Physiology-Based Pharmacokinetic Modeling to Predict Drug Exposure and Pharmacodynamics in Skin and Bone Tissues.
Bourguignon, L; Ferry, T; Garreau, R; Goutelle, S; Grillon, A; Jehl, F; Montange, D, 2022
)
0.72
" Results of dosing simulations showed that doses ≥10 mg/kg should be used in the case of bacteremia caused by Staphylococcus aureus with a minimum inhibitory concentration >0."( Daptomycin Physiology-Based Pharmacokinetic Modeling to Predict Drug Exposure and Pharmacodynamics in Skin and Bone Tissues.
Bourguignon, L; Ferry, T; Garreau, R; Goutelle, S; Grillon, A; Jehl, F; Montange, D, 2022
)
0.72
"We developed the first daptomycin PBPK/pharmacodynamic model for bone and joint infection, which confirmed that a higher daptomycin dosage is needed to optimize exposure in bone tissue."( Daptomycin Physiology-Based Pharmacokinetic Modeling to Predict Drug Exposure and Pharmacodynamics in Skin and Bone Tissues.
Bourguignon, L; Ferry, T; Garreau, R; Goutelle, S; Grillon, A; Jehl, F; Montange, D, 2022
)
0.72
" In obese patients, daptomycin dosage adjustment with total body-weight and adjusted body-weight may lead to an apparent excessive exposure resulting in overdosage compared to lean body-weight."( Characterization of plasma daptomycin in patients with serum highly glycated albumin and obesity.
Imoto, Y; Kawakami, J; Miyadera, Y; Naito, T; Yagi, T; Yamada, T, 2023
)
0.91
"No studies exploring the efficacy of routine daptomycin TDM on patient-centred outcomes in comparison with fixed dosing regimens have been published to date."( The impact of daptomycin therapeutic drug monitoring on clinical outcomes: a systematic review.
Abbott, IJ; Cairns, KA; Dooley, MJ; Peel, TN; Peleg, AY; Udy, AA, 2023
)
0.91
" An aim of the study includes evaluation of PK of daptomycin in Japanese pediatric patients and an appropriateness of the age-specific, weight-based dosing regimens in Japanese pediatric patients based on PK comparison with Japanese adult patients."( Pharmacokinetics of intravenous daptomycin in Japanese pediatric patients: Pharmacokinetic comparisons supporting dosing recommendations in Japanese pediatric patients.
Ishii, M; Orito, Y; Shiomi, M; Wrishko, RE; Yoshitsugu, H, 2023
)
0.91
"Following administration of the age-specific, weight-based dosing regimens, daptomycin exposures were overlapping across age groups in pediatric patients with cSSTI with similar observations based on clearance."( Pharmacokinetics of intravenous daptomycin in Japanese pediatric patients: Pharmacokinetic comparisons supporting dosing recommendations in Japanese pediatric patients.
Ishii, M; Orito, Y; Shiomi, M; Wrishko, RE; Yoshitsugu, H, 2023
)
0.91
"The results suggested that the age-specific, weight-based dosing regimens are considered to be appropriate in Japanese pediatric patients."( Pharmacokinetics of intravenous daptomycin in Japanese pediatric patients: Pharmacokinetic comparisons supporting dosing recommendations in Japanese pediatric patients.
Ishii, M; Orito, Y; Shiomi, M; Wrishko, RE; Yoshitsugu, H, 2023
)
0.91
" However, more robust research is required to establish an optimal dosing regimen, duration of therapy, and place in therapy for the management of meningitis."( Daptomycin for the treatment of acute bacterial meningitis: A narrative review.
Beahm, NP; Jaber, RH, 2023
)
0.91
" This study aimed to evaluate dosing regimens for coadministration of daptomycin and ceftaroline in special populations including paediatrics, renally impaired (RI), obese and geriatrics that generate sufficient coverage against daptomycin-resistant MRSA."( Physiologically based pharmacokinetic modelling to inform combination dosing regimens of ceftaroline and daptomycin in special populations.
Annaert, P; Martins, FS; Martins, JES; Severino, P; Sy, SKB, 2023
)
0.91
"The adult dosing regimens of 6 mg/kg every (q)24h or q48h daptomycin and 300-600 mg q12h ceftaroline fosamil by RI categories achieved ≥90% joint PTA when the minimum inhibitory concentrations in the combination are at or below 1 and 4 μg/mL against MRSA."( Physiologically based pharmacokinetic modelling to inform combination dosing regimens of ceftaroline and daptomycin in special populations.
Annaert, P; Martins, FS; Martins, JES; Severino, P; Sy, SKB, 2023
)
0.91
"Our work illustrates how physiologically based pharmacokinetic modelling can inform appropriate dosing of adult and paediatric patients and thereby enable prediction of target attainment in the patients during multitherapies."( Physiologically based pharmacokinetic modelling to inform combination dosing regimens of ceftaroline and daptomycin in special populations.
Annaert, P; Martins, FS; Martins, JES; Severino, P; Sy, SKB, 2023
)
0.91
"Few drug dosing recommendations for patients receiving home hemodialysis (HHD) have been published which has hindered the adoption of HHD."( Vancomycin and daptomycin dosing recommendations in patients receiving home hemodialysis using Monte Carlo simulation.
Jang, SM; Lewis, SJ; Mueller, BA, 2023
)
0.91
"HHD frequency, total dialysate volumes and HHD durations influenced drug exposure and led to different dosing regimens to meet targets."( Vancomycin and daptomycin dosing recommendations in patients receiving home hemodialysis using Monte Carlo simulation.
Jang, SM; Lewis, SJ; Mueller, BA, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,202)

TimeframeStudies, This Drug (%)All Drugs %
pre-199081 (3.68)18.7374
1990's74 (3.36)18.2507
2000's500 (22.71)29.6817
2010's1240 (56.31)24.3611
2020's307 (13.94)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials75 (3.31%)5.53%
Reviews261 (11.52%)6.00%
Case Studies337 (14.87%)4.05%
Observational26 (1.15%)0.25%
Other1,567 (69.15%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (94)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
[NCT01212432]Phase 215 participants (Anticipated)Interventional2009-12-31Recruiting
A Phase II Open-Label, Single-arm Clinical Trial to Study the Safety, Efficacy and Pharmacokinetics of MK-3009 (Daptomycin) in Japanese Pediatric Participants Aged 1 to 17 Years With Complicated Skin and Soft Tissue Infections or Bacteremia Caused by Gram [NCT03643952]Phase 218 participants (Actual)Interventional2018-12-06Completed
Daptomycin Use For Prophylaxis In Prosthetic Joint Surgery, A Randomized Prospective Study Comparing The Efficacy Of Daptomycin Versus Vancomycin For Peri-Operative Antibiotic Prophylaxis In MRSA Colonized Adult Patients Undergoing Primary Elective Hip, K [NCT01196169]Phase 428 participants (Actual)Interventional2010-10-31Terminated(stopped due to The study is closed to accrual. Enrollment of new patients stopped at the request of CUBIST Pharmaceuticals due to slow rate of enrollment.)
Comparison of the Pharmacokinetic and the Safety of Daptomycin Administered Subcutaneously Compared to the Intravenous Route : a Cross-over Study [NCT04434300]Phase 112 participants (Actual)Interventional2020-10-15Completed
A Randomized, Double-Blind Study Comparing Three Dosing Regimens of Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) [NCT02052388]Phase 2215 participants (Actual)Interventional2014-02-28Completed
Open Label, Single Center Study to Evaluate Higher Doses of Daptomycin in the Treatment of Patients With Severe Necrotizing Skin and Soft Tissue Infections. [NCT00261807]25 participants (Actual)Interventional2005-06-30Completed
Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy [NCT01080963]Phase 4650 participants (Actual)Interventional2008-11-30Completed
Acute Kidney Injury During Daptomycin Versus Vancomycin Treatment in Cardiovascular Critically Ill Patients: a Propensity Score Matched Analysis [NCT03961503]72 participants (Actual)Observational2016-01-01Completed
The Pharmacokinetics and Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock [NCT02508350]12 participants (Anticipated)Interventional2015-01-31Recruiting
Utility Assessment of a Pharmacy-to-Dose Daptomycin Protocol: A Retrospective Cohort Study [NCT05224687]100 participants (Anticipated)Observational2021-12-15Enrolling by invitation
[NCT02142075]Phase 30 participants Interventional2014-03-31Completed
Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus Aureus [NCT01211470]Phase 2215 participants (Actual)Interventional2010-10-31Completed
Efficacy and Safety of Daptomycin (With or Without Rifampin) in the Treatment of Staphylococcal Hip, Knee and Shoulder Prosthetic Joint Infection [NCT01144000]Phase 260 participants (Anticipated)Interventional2012-06-30Not yet recruiting
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study [NCT03480191]Phase 2128 participants (Anticipated)Interventional2018-06-07Recruiting
Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL) [NCT05156437]Phase 420 participants (Anticipated)Interventional2022-03-16Enrolling by invitation
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study [NCT01171547]Phase 215 participants (Anticipated)Interventional2010-02-28Recruiting
Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment [NCT01199783]Phase 31 participants (Actual)Interventional2011-07-31Terminated(stopped due to Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.)
Dalbavancin For The Treatment Of Gram Positive Osteomyelitis Or Joint Infections Including Prosthetic Hip Or Knee Infections [NCT03426761]Phase 441 participants (Actual)Interventional2018-01-25Completed
A Two Cohort, Open Label, Single and Multiple Dose Pharmacokinetic Study of 4mg/Kg and 6mg/Kg Doses of Daptomycin in Healthy Chinese Subjects Living in China [NCT00858325]Phase 124 participants (Actual)Interventional2009-02-28Completed
Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial [NCT05977868]Phase 4135 participants (Anticipated)Interventional2023-08-04Enrolling by invitation
Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin [NCT02097953]Early Phase 112 participants (Actual)Interventional2014-05-31Completed
Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): A Phase 2b, Multicenter, Randomized, Open-Label, Assessor-Blinded Superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Com [NCT04775953]Phase 2200 participants (Actual)Interventional2021-04-22Active, not recruiting
Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections [NCT00467272]Phase 230 participants (Actual)Interventional2007-03-31Completed
A Phase 2 Multicenter, Randomized, Double-blinded, Study to Describe the Safety, Efficacy, and Pharmacokinetics of Daptomycin 10 mg/kg/Day and Vancomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia [NCT00695903]Phase 238 participants (Actual)Interventional2008-09-17Terminated(stopped due to terminated due to lack of enrollment)
A Multicenter, Randomized, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI) [NCT00430937]Phase 3194 participants (Actual)Interventional2006-04-30Terminated
A Multi-center Prospective Randomized Open Label Study of Utilizing Interleukin 10 (IL-10) Levels as a Guide for Antibiotic Selection for Methicillin Resistant Staphylococcus Aureus Bacteremia [NCT02660346]Phase 440 participants (Actual)Interventional2015-11-30Completed
A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA) [NCT00463801]Phase 452 participants (Actual)Interventional2007-01-31Terminated(stopped due to Because of inadequate accrual.)
Cubicin(R) for Complicated Post-surgical Wound Infections [NCT00651131]Phase 469 participants (Actual)Interventional2004-06-01Terminated(stopped due to terminated due to slow enrollment)
An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis [NCT00490737]Phase 112 participants (Actual)Interventional2007-08-12Completed
A Prospective, Randomized, Crossover-design Study to Evaluate the Pharmacokinetics and Safety of Daptomycin Administered at 9 mg/kg During and 6 mg/kg After Hemodialysis [NCT00882557]Phase 116 participants (Actual)Interventional2009-04-29Completed
An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection [NCT00679835]Phase 124 participants (Actual)Interventional2008-06-03Completed
Ceftriaxone as Home Intravenous Therapy for Deep-Seated Staphylococcal Infections, a Randomized Non-Inferiority Trial [NCT04141787]Phase 4310 participants (Anticipated)Interventional2019-07-11Recruiting
Prospective Study Evaluating Plasma Exposure of Optimized Antibiotic Therapy According to TDM in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC) [NCT04132115]104 participants (Anticipated)Observational2019-10-01Recruiting
An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged 3 Months to Twenty-Four Months Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Bacterial Infection Includi [NCT01019395]Phase 123 participants (Actual)Interventional2010-01-05Completed
A Multi-Center, Randomized, Open-Label, Comparative Study to Assess the Safety and Efficacy of a Treatment Algorithm to Reduce the Use of Vancomycin in Adult Patients With Blood Stream Infections Due to Staphylococci [NCT01191840]Phase 2509 participants (Actual)Interventional2011-02-28Completed
The Influence Factors of Pharmacokinetics/Pharmacodynamics of Daptomycin in Severe Patients and the the Effect of Different Blood Concentration of Daptomycin on the Outcomes of Renal Function [NCT04277143]120 participants (Anticipated)Observational2020-12-01Not yet recruiting
A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared With That of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in t [NCT00772447]Phase 3265 participants (Actual)Interventional2008-09-30Completed
Randomized Multicenter Study to Assess Efficacy of Daptomycin Plus Fosfomycin Versus Daptomycin Monotherapy for Treatment of Methicillin Resistant Staphylococcus Aureus Bacteremia in Hospitalized Patients [NCT01898338]Phase 3167 participants (Actual)Interventional2013-12-31Completed
Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection [NCT02000414]8 participants (Actual)Interventional2013-09-30Completed
A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthet [NCT00428844]Phase 275 participants (Actual)Interventional2007-06-26Completed
Open Label Study to Assess the Efficacy and Safety of Daptomycin in Combination With Anti-Cell Wall Active Therapy in the Treatment of Enterococcal Endocarditis [NCT00401960]Phase 46 participants (Actual)Interventional2006-09-30Terminated(stopped due to inadequate enrollment)
A Multi-centre Open Label Randomized Controlled Phase IIB Trial Comparing Vancomycin Versus Daptomycin for the Treatment of MRSA Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations [NCT01975662]Phase 214 participants (Actual)Interventional2014-01-31Terminated(stopped due to slow accrual of participants)
Non-interventional Observational Study of Daptomycin in the Treatment of Gram-positive Bacterial Infections [NCT04546815]2,000 participants (Anticipated)Observational2020-08-25Recruiting
A Phase 4, Prospective, Randomized, Open-label Study to Compare Use of Cubicin With Vancomycin Administered Intravenously in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Confirmed Gram-positive Bacteria [NCT01175707]Phase 480 participants (Actual)Interventional2010-07-15Terminated(stopped due to Business decision)
An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens [NCT00711802]Phase 4396 participants (Actual)Interventional2008-07-23Completed
An Open Label, Multi-center, Randomized, Comparative Phase IIIb Study to Compare Efficacy and Safety of Intravenous (i.v.) Daptomycin With That of Semi-Synthetic Penicillins (SSPs) or Vancomycin in the Treatment of Elderly Patients (Aged ≥ 65 Years) With [NCT01184872]Phase 3120 participants (Actual)Interventional2010-03-31Completed
A Randomized, Double-Blind, Phase III, Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae [NCT00538694]Phase 30 participants Interventional2000-10-31Completed
An Investigator Initiated, Phase IV Single-Center, Randomized, Open-Label, Prospective Study to Determine the Impact of Serial Procalcitonin on Improving Antimicrobial Stewardship and on the Efficacy, Safety, and Tolerability of Imipenem - Relebactam Plus [NCT04983901]Phase 2100 participants (Actual)Interventional2021-09-14Active, not recruiting
A Phase 3, Multicenter, Randomized, Open-Label, Comparative Study to Assess the Safety and Efficacy of Daptomycin Compared to Conventional Therapy In the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to Staph Aureus [NCT00093067]Phase 30 participants Interventional2002-03-31Completed
[NCT01756924]Phase 214 participants (Actual)Interventional2012-12-31Terminated(stopped due to This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.)
A Prospective, Multicenter, Randomized, Evaluator-blinded, Comparator-controlled Study to Describe the Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin Structure Infections (cSSSI) and Staphylococcus Aureus Bacteremia Among [NCT01104662]Phase 492 participants (Actual)Interventional2010-04-19Terminated(stopped due to Cubist has reached an agreement with the FDA that enrollment in the DAP-RENSE-08-05 study can stop.)
A Phase III Randomized, Open-labeled Clinical Trial of MK-3009 (Daptomycin) in Patients With Skin and Soft Tissue Infections, Septicemia and Right-sided Infective Endocarditis Caused by MRSA [NCT00770341]Phase 3122 participants (Actual)Interventional2008-09-30Completed
Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections [NCT04933344]1,130 participants (Anticipated)Observational2021-06-15Recruiting
[NCT01287832]Phase 411 participants (Actual)Interventional2011-06-30Terminated(stopped due to Low patient enrollment)
[NCT00540072]Phase 30 participants Interventional2001-07-30Completed
Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®) [NCT04033029]20 participants (Actual)Observational2021-01-01Completed
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease [NCT01012089]6 participants (Actual)Interventional2009-11-30Completed
An Open Label Phase 4 Trial to Further Evaluate the Pharmacokinetic Profile of Intravenous Daptomycin, and a Comparison of the Safety and Efficacy of Daptomycin Versus Comparator in the Treatment of Adult Patients With Renal Impairment and Complicated Ski [NCT00102947]Phase 472 participants Interventional2005-01-31Terminated
An Evaluation of the Pharmacokinetics of a Single Dose of Daptomycin (4 mg/kg) in Pediatric Patients Aged Two to Seventeen Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection [NCT00136292]Phase 133 participants (Actual)Interventional2005-08-24Completed
Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus Bloodstream Infections [NCT00507247]Phase 211 participants (Actual)Interventional2006-05-31Completed
A Randomized, Multicenter Trial of Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated Methicillin-resistant Staphylococcus Aureus Bacteremia [NCT01515020]Phase 310 participants (Actual)Interventional2012-05-31Terminated(stopped due to lack of inclusion)
Evaluation of Cerebrospinal Fluid Concentration of Daptomycin (Cubicin¬) in Pediatric Patients With Gram-positive Bacterial Meningitis, Concurrently Receiving Standard Antimicrobial Therapy [NCT01522105]Phase 11 participants (Actual)Interventional2012-04-30Terminated(stopped due to Insufficient patient recruitment)
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation [NCT01551719]0 participants (Actual)Interventional2012-03-31Withdrawn
A Compassionate Use Protocol for Intravenous Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria That Cannot be Adequately Treated With Currently Available Therapy [NCT00055198]Phase 375 participants Interventional2002-12-19Terminated(stopped due to Study terminated due to low enrollment)
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery [NCT00701636]Phase 330 participants (Actual)Interventional2008-07-31Completed
Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD) [NCT00663403]Phase 48 participants (Actual)Interventional2007-02-28Completed
An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients [NCT00296049]0 participants (Actual)Interventional2005-07-31Withdrawn
A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas [NCT00295178]Phase 480 participants Interventional2006-02-20Completed
[NCT00451373]300 participants Interventional2006-07-31Recruiting
Effects of Daptomycin in the Levels of IL-1, IL-6 and TNF in Patients With Complicated Cellulitis/Erisipela in Comparison With Vancomycin or Oxacillin [NCT01626560]Phase 420 participants (Actual)Interventional2012-07-31Completed
Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection [NCT01792804]Phase 3215 participants (Actual)Interventional2013-12-31Completed
Cerebrospinal Fluid Pharmacokinetics of Daptomycin [NCT01025271]2 participants (Actual)Interventional2010-05-31Terminated(stopped due to unable to enroll subjects study stopped due to lack of enrollment)
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury [NCT02241941]Phase 40 participants (Actual)Interventional2014-09-30Withdrawn(stopped due to Assessment of daptomycin concentrations with microdialysis technically not feasible)
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants [NCT00942149]Phase 120 participants (Actual)Interventional2010-01-31Completed
A Pilot Study of Daptomycin for Antimicrobial Prophylaxis in Patients Undergoing Cardiac Valve Replacement and Coronary Artery Bypass Grafting (CABG) Who Are at Increased Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus (MRSA) [NCT00572260]Phase 411 participants (Actual)Interventional2008-01-31Terminated(stopped due to Study closed. PI left the institution.)
Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients [NCT01734694]Phase 4100 participants (Actual)Interventional2011-10-31Terminated(stopped due to Independent biostatistician recommended early termination of the trial due to low probability of success.)
Concentration and Antibiotic Activity in Antibiotic Lock Solutions [NCT01592032]Phase 4125 participants (Anticipated)Interventional2012-05-31Active, not recruiting
A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever. [NCT01216241]Phase 336 participants (Actual)Interventional2011-04-30Terminated(stopped due to The study has shown futility and the objectives could not be reached without enrolling a very large number of subjects.)
Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis: an Open, Randomized, Controlled Clinical Trial [NCT01455246]Phase 2/Phase 332 participants (Actual)Interventional2010-10-31Terminated(stopped due to Decision of independent monitoring committee after interim analysis: Risk of failure significantly higher in ceftazidime group.)
Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever [NCT00335478]Phase 254 participants (Actual)Interventional2006-12-31Completed
Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria [NCT00426933]Phase 2100 participants (Actual)Interventional2007-01-31Completed
Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia [NCT02972983]Phase 4102 participants (Actual)Interventional2016-12-01Completed
Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients [NCT03004066]9 participants (Actual)Observational2016-10-31Completed
A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects One - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus. [NCT01728376]Phase 482 participants (Actual)Interventional2012-11-29Completed
Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections [NCT01549613]Phase 4104 participants (Actual)Interventional2012-05-31Completed
Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class (i.v. Lipo and Glyco-peptides) in Patients With ABSSSI [NCT04298463]184 participants (Actual)Observational2020-06-18Completed
Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin [NCT04414137]20 participants (Anticipated)Observational2019-02-19Recruiting
A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms [NCT01922011]Phase 3149 participants (Actual)Interventional2013-09-13Completed
Staphylococcus Aureus Network Adaptive Platform Trial [NCT05137119]Phase 46,000 participants (Anticipated)Interventional2022-02-16Recruiting
A Phase 4 Multicenter, Randomized, Double Blind Study to Describe the Efficacy and Safety of Cubicin® (Daptomycin for Injection) With and Without Initial Gentamicin Combination Therapy in the Treatment of S. Aureus Infective Endocarditis [NCT00638157]Phase 424 participants (Actual)Interventional2009-02-13Terminated(stopped due to commitment completed)
A Randomized Study to Evaluate Comparative Effectiveness, Inpatient Resource Utilization, and Cost of Daptomycin vs. Vancomycin in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Documented Methicillin-res [NCT01419184]Phase 4250 participants (Actual)Interventional2011-09-09Completed
A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis [NCT03138733]Phase 3390 participants (Actual)Interventional2018-08-26Completed
A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including Infective Endocarditis [NCT02208063]Phase 3121 participants (Actual)Interventional2014-12-31Terminated(stopped due to Halted due to lack of statistical power. No safety concerns identified.)
Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for the Treatment of Diabetic Foot Osteomyelitis (CRO-OSTEOMYELITIS) [NCT02168816]Phase 230 participants (Actual)Interventional2014-03-19Terminated(stopped due to The study was stopped for feasibility (i.e., low recruitment))
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00261807 (3) [back to overview]Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
NCT00261807 (3) [back to overview]Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
NCT00261807 (3) [back to overview]Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)
NCT00335478 (1) [back to overview]Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
NCT00401960 (2) [back to overview]Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)
NCT00401960 (2) [back to overview]Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria
NCT00428844 (6) [back to overview]Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)
NCT00428844 (6) [back to overview]Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)
NCT00428844 (6) [back to overview]Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)
NCT00428844 (6) [back to overview]Microbiological Response
NCT00428844 (6) [back to overview]Overall Clinical Outcome
NCT00428844 (6) [back to overview]Safety - Notable Laboratory Abnormalities
NCT00430937 (2) [back to overview]Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.
NCT00430937 (2) [back to overview]"Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population."
NCT00463801 (1) [back to overview]Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
NCT00467272 (6) [back to overview]Clinical Response Within 48 Hours
NCT00467272 (6) [back to overview]Clinical Response Within 7 Days
NCT00467272 (6) [back to overview]Microbiological Response Within 48 Hours
NCT00467272 (6) [back to overview]Microbiological Response Within 7 Days
NCT00467272 (6) [back to overview]Number of Participants With Overall Response
NCT00467272 (6) [back to overview]Relapse
NCT00638157 (2) [back to overview]Summary of the Investigator's Assessment of Clinical Response at the TOC Visit
NCT00638157 (2) [back to overview]Summary of Clinically Significant Increases in Serum Creatinine by Visit
NCT00663403 (7) [back to overview]Daptomycin Volume of Distribution at Steady State
NCT00663403 (7) [back to overview]Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis
NCT00663403 (7) [back to overview]Daptomycin Total Body Clearance
NCT00663403 (7) [back to overview]Daptomycin Half-life
NCT00663403 (7) [back to overview]Daptomycin Free Fraction
NCT00663403 (7) [back to overview]Daptomycin Dose Actually Administered
NCT00663403 (7) [back to overview]Observed Daptomycin Peak Serum Concentration
NCT00695903 (4) [back to overview]Number of Participants With Treatment Cure at End of Therapy (EOT) Visit
NCT00695903 (4) [back to overview]Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit
NCT00695903 (4) [back to overview]Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations
NCT00695903 (4) [back to overview]Number of Participants With Elevated Serum Creatinine
NCT00701636 (1) [back to overview]Mean Daptomycin Concentrations at 12, 18, 24, and 48 h
NCT00711802 (3) [back to overview]Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT00711802 (3) [back to overview]Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
NCT00711802 (3) [back to overview]Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])
NCT00770341 (6) [back to overview]Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC
NCT00770341 (6) [back to overview]Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)
NCT00770341 (6) [back to overview]EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).
NCT00770341 (6) [back to overview]EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).
NCT00770341 (6) [back to overview]Study Investigators' Assessment of Clinical Response at TOC
NCT00770341 (6) [back to overview]Study Investigators' Assessment of Clinical Response at EOT
NCT00772447 (12) [back to overview]Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)
NCT00772447 (12) [back to overview]Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
NCT00772447 (12) [back to overview]Change in Creatinine Clearance
NCT00772447 (12) [back to overview]Change in Serum Total Creatine Phosphokinase (CPK)
NCT00772447 (12) [back to overview]Change in Urine pH
NCT00772447 (12) [back to overview]Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
NCT00772447 (12) [back to overview]Microbiological Response at EOT(End of Therapy)
NCT00772447 (12) [back to overview]Microbiological Response at TOC(Test of Cure)
NCT00772447 (12) [back to overview]Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)
NCT00772447 (12) [back to overview]Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC
NCT00772447 (12) [back to overview]Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC
NCT00772447 (12) [back to overview]Shift in ECG
NCT00882557 (7) [back to overview]Volume of Distribution
NCT00882557 (7) [back to overview]Clearance of Daptomycin
NCT00882557 (7) [back to overview]Evaluation of Area Under the Curve From Time 0 to Infinity
NCT00882557 (7) [back to overview]Half-life
NCT00882557 (7) [back to overview]Maximum Plasma Concentration
NCT00882557 (7) [back to overview]Time to Maximum Concentration
NCT00882557 (7) [back to overview]Treatment-emergent Adverse Events
NCT00942149 (1) [back to overview]PK of Daptomycin
NCT01012089 (8) [back to overview]Maximum Plasma Concentration (Cmax)
NCT01012089 (8) [back to overview]Elimination Rate Constant (Ke)
NCT01012089 (8) [back to overview]Drug Clearance Due to Dialysis (CLdialysis)
NCT01012089 (8) [back to overview]Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)
NCT01012089 (8) [back to overview]Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)
NCT01012089 (8) [back to overview]Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)
NCT01012089 (8) [back to overview]Total Drug Clearance (CLtotal)
NCT01012089 (8) [back to overview]Volume of Distribution at Steady State (Vss)
NCT01104662 (2) [back to overview]Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit
NCT01104662 (2) [back to overview]Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)
NCT01175707 (15) [back to overview]Time Spent (Minutes) for Home Infusion Therapy
NCT01175707 (15) [back to overview]Reasons for Pharmacist Consultations During Home Infusion Therapy
NCT01175707 (15) [back to overview]Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
NCT01175707 (15) [back to overview]Reasons for Nurse Visits During Home Infusion Therapy
NCT01175707 (15) [back to overview]Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
NCT01175707 (15) [back to overview]Mean Number of Interventions Per Participant During Home Infusion Therapy
NCT01175707 (15) [back to overview]Number of Intervention Types During Home Infusion Therapy
NCT01175707 (15) [back to overview]Number of Laboratory Assessment Types During Home Infusion Therapy
NCT01175707 (15) [back to overview]Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
NCT01175707 (15) [back to overview]Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
NCT01175707 (15) [back to overview]Percentage of Treatment Goals Met at End of Therapy
NCT01175707 (15) [back to overview]Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
NCT01175707 (15) [back to overview]Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
NCT01175707 (15) [back to overview]Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
NCT01175707 (15) [back to overview]Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
NCT01184872 (5) [back to overview]Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
NCT01184872 (5) [back to overview]Number of Patients With Adverse Events, Serious Adverse Events and Death
NCT01184872 (5) [back to overview]Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
NCT01184872 (5) [back to overview]Duration of Treatment (Intravenous)
NCT01184872 (5) [back to overview]Duration of Treatment (Intravenous and Oral)
NCT01191840 (5) [back to overview]Antibiotic Days by Treatment Group
NCT01191840 (5) [back to overview]Cure Rate
NCT01191840 (5) [back to overview]Number of Participants With Serious Adverse Events
NCT01191840 (5) [back to overview]Number of Participants With Adverse Events Leading to Study Drug Withdrawal
NCT01191840 (5) [back to overview]Number of Participants That Changed From Vancomycin to Another Study Antibiotic Due to an Adverse Event
NCT01216241 (1) [back to overview]Percentage of Afebrile Neutropenic Subjects
NCT01287832 (1) [back to overview]Number of Participants With Clinical Success at Test of Cure Visit.
NCT01419184 (6) [back to overview]Participant Global Impression of Improvement (PGI-I) at Hospital Discharge
NCT01419184 (6) [back to overview]30-day cSSSI-related Hospital Readmission Rates
NCT01419184 (6) [back to overview]Infection-Related Hospital Length of Stay
NCT01419184 (6) [back to overview]Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)
NCT01419184 (6) [back to overview]Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)
NCT01419184 (6) [back to overview]cSSSI-related Medical Resource Utilization and Costs
NCT01549613 (1) [back to overview]Satisfaction of Discharge Criteria
NCT01728376 (9) [back to overview]Percentage of Participants With Overall Success at TOC Visit
NCT01728376 (9) [back to overview]Percentage of Participants With Sustained CPK Elevations
NCT01728376 (9) [back to overview]Trough Plasma Concentration of Daptomycin
NCT01728376 (9) [back to overview]Number of Participants With One or More Serious Adverse Events (SAEs)
NCT01728376 (9) [back to overview]Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)
NCT01728376 (9) [back to overview]Percentage of Participants With Clinical Success at TOC/Safety Visit
NCT01728376 (9) [back to overview]Maximum Plasma Concentration (Cmax) of Daptomycin
NCT01728376 (9) [back to overview]Number of Participants With One or More Adverse Events (AEs)
NCT01728376 (9) [back to overview]Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal
NCT01734694 (2) [back to overview]Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity
NCT01734694 (2) [back to overview]Proportion of Individuals With Nephrotoxicity
NCT01922011 (13) [back to overview]Plasma Concentration of Daptomycin at the End of IV Infusion
NCT01922011 (13) [back to overview]Concentration of Serum Creatine Kinase (CK)
NCT01922011 (13) [back to overview]Percentage of Participants With a Clinical Cure Categorized by Baseline Pathogen at Test of Cure
NCT01922011 (13) [back to overview]Percentage of Participants With a Favorable Clinical Outcome
NCT01922011 (13) [back to overview]Percentage of Participants With a Favorable Microbiological Response Categorized by Baseline Pathogen at Test of Cure
NCT01922011 (13) [back to overview]Percentage of Participants With Sustained Clinical Improvement
NCT01922011 (13) [back to overview]Number of Participants With 1 or More Adverse Events (AEs)
NCT01922011 (13) [back to overview]Number of Participants With 1 or More Serious Adverse Events (SAEs)
NCT01922011 (13) [back to overview]Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories.
NCT01922011 (13) [back to overview]Percentage of Participants With Clinical Improvement Measured as a Composite End Point of Pain, Inflammation, Limb Function, Body Temperature, and C-reactive Protein at End-of IV (EOIV) Therapy Visit.
NCT01922011 (13) [back to overview]Plasma Concentration of Daptomycin at 15 Minutes to 1 Hour After the End of IV Infusion
NCT01922011 (13) [back to overview]Plasma Concentration of Daptomycin at 2 to 3 Hours After the End of IV Infusion
NCT01922011 (13) [back to overview]Plasma Concentration of Daptomycin at 4 to 5 Hours After the End of IV Infusion
NCT02208063 (4) [back to overview]Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
NCT02208063 (4) [back to overview]Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
NCT02208063 (4) [back to overview]Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population
NCT02208063 (4) [back to overview]Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations
NCT03138733 (6) [back to overview]Number of Patients With Microbiological Eradication at the PTE Visit
NCT03138733 (6) [back to overview]Time to Staphylococcus Aureus Bloodstream Clearance
NCT03138733 (6) [back to overview]All-cause Mortality at the PTE Visit
NCT03138733 (6) [back to overview]Number of Patients With or Without Adverse Events (AEs)
NCT03138733 (6) [back to overview]Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit
NCT03138733 (6) [back to overview]Number of Patients With or Without Overall Success at the PTE Visit in the CE Population
NCT03643952 (16) [back to overview]Maximum Plasma Concentration (Cmax) of Daptomycin
NCT03643952 (16) [back to overview]Body Weight Adjusted Clearance (CLss/wt) of Daptomycin
NCT03643952 (16) [back to overview]Body Weight Adjusted Clearance (CLss/wt) of Daptomycin
NCT03643952 (16) [back to overview]Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin
NCT03643952 (16) [back to overview]Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin
NCT03643952 (16) [back to overview]Apparent Terminal Half-Life (t½) of Daptomycin
NCT03643952 (16) [back to overview]Apparent Terminal Half-Life (t½) of Daptomycin
NCT03643952 (16) [back to overview]Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response
NCT03643952 (16) [back to overview]Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success
NCT03643952 (16) [back to overview]Time to Maximum Plasma Concentration (Tmax) of Daptomycin
NCT03643952 (16) [back to overview]Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE)
NCT03643952 (16) [back to overview]Volume of Distribution at Steady State (Vss) of Daptomycin
NCT03643952 (16) [back to overview]Volume of Distribution at Steady State (Vss) of Daptomycin
NCT03643952 (16) [back to overview]Time to Maximum Plasma Concentration (Tmax) of Daptomycin
NCT03643952 (16) [back to overview]Percentage of Participants With an Adverse Event
NCT03643952 (16) [back to overview]Maximum Plasma Concentration (Cmax) of Daptomycin

Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)

"Clinical response was assessed by measuring impact of therapy on certain wound parameters. Specifically Erythema, Induration/Swelling, Suppuration, were recorded visually and WBC Counts were considered improved if <12,000/cu mm.~The clinical response was documented as:~CURE (resolution of clinical signs and symptoms and no additional need for gram-positive antibiotic therapy.~IMPROVED (partial resolution of clinical signs and symptoms (although patient's clinical status had not completely returned to preinfection baseline but infectious process had been controlled , no additional gram-positive antibiotic therapy was needed;~FAILURE (no response, worsening of clinical signs and symptoms of infection; or additional gram-positive antibiotic therapy was needed );~UNABLE TO EVALUATE (unable to determine response; e.g., no evaluation performed at specified time points, or administration of non-study antibiotics effective against study pathogen)." (NCT00261807)
Timeframe: The clinical response was measured at the end of treatment (7-14 days)

InterventionParticipants (Count of Participants)
Erythema-EOT72552002Induration EOT72552002Suppuration-EOT72552002WBC Counts EOT72552002
ImprovedFailureUnable to EvaluateCure
Single ARM Study16
Single ARM Study2
Single ARM Study17
Single ARM Study1
Single ARM Study0
Single ARM Study13
Single ARM Study5
Single ARM Study18

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Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)

"Clinical response was assessed by measuring impact of therapy on certain wound parameters. Specifically Erythema, Induration/Swelling, Suppuration, were recorded visually and WBC Counts were considered improved if <12,000/cu mm.~The clinical response was documented as:~CURE (resolution of clinical signs and symptoms and no additional need for gram-positive antibiotic therapy.~IMPROVED (partial resolution of clinical signs and symptoms (although patient's clinical status had not completely returned to preinfection baseline but infectious process had been controlled , no additional gram-positive antibiotic therapy was needed;~FAILURE (no response, worsening of clinical signs and symptoms of infection; or additional gram-positive antibiotic therapy was needed );~UNABLE TO EVALUATE (unable to determine response; e.g., no evaluation performed at specified time points, or administration of non-study antibiotics effective against study pathogen)." (NCT00261807)
Timeframe: The clinical response was measured at Test of Cure (3-28 days post end of treatment)

InterventionParticipants (Count of Participants)
Erythema-TOC72552003Induration TOC72552003Suppuration72552003WBC Counts-TOC72552003
FailureUnable to EvaluateCureImproved
Single ARM Study18
Single ARM Study0

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Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)

"Bacterial cultures were obtained in all patients and repeated if the patient had a second surgical intervention.~The microbiological responses were documented as follows:~DOCUMENTED ERADICATED: the baseline infecting pathogen was absent at end of treatment as determined by a negative culture.~PRESUMED ERADICATED: The baseline infection was presumed absent at the end of treatment as determined that there was nothing to culture.~DOCUMENTED PERSISTENT: The baseline infecting pathogen was present at the end of treatment." (NCT00261807)
Timeframe: The microbiologicall response will be measured at the end of treatment (7-14 days) and Test of Cure (TOC) (3-28 days)

InterventionParticipants (Count of Participants)
End of Therapy72552002Test of Cure72552002
Presumed EradicatedDocumented EradicatedDocumented Persistent
Single ARM Study23
Single ARM Study18
Single ARM Study0

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Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.

"If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued.~Complete Response: Resolution of fever and clinical signs/symptoms of infection.~Partial Response: Resolution of fever without resolution of clinical signs of infection." (NCT00335478)
Timeframe: Within 72 hours of starting daptomycin

Interventionparticipants (Number)
Daptomycin16

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Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)

Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details (NCT00401960)
Timeframe: weekly

InterventionParticipants (Count of Participants)
Adjunctive Daptomycin Group4
Standard of Care Group0

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Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria

Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline (NCT00401960)
Timeframe: weekly

,
InterventionParticipants (Count of Participants)
Elevated serum creatinine >= 30% above baselineElevate serum creatine kinase > 3X ULN
Daptomycin Adjunctive Group10
Standard of Care10

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Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)

Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory. (NCT00428844)
Timeframe: From the 3rd day of therapy to 1 week post last dose (approximately week 7)

InterventionParticipants (Number)
Daptomycin 6 mg/kg4
Daptomycin 8 mg/kg5
Comparator2

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Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)

The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. (NCT00428844)
Timeframe: Day 4 (steady state)

Interventionµg•hr/mL (Median)
Daptomycin 6 mg/kg499
Daptomycin 8 mg/kg821

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Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)

The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. (NCT00428844)
Timeframe: Day 4 (steady state)

Interventionµg/mL (Median)
Daptomycin 6 mg/kg59.1
Daptomycin 8 mg/kg92.3

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Microbiological Response

Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population. (NCT00428844)
Timeframe: Approximately 6 weeks post last dose (approximately week 12)

,,
InterventionParticipants (Number)
SuccessFailureNon-evaluable
Comparator867
Daptomycin 6 mg/kg1284
Daptomycin 8 mg/kg1238

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Overall Clinical Outcome

The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable. (NCT00428844)
Timeframe: Approximately 6 weeks post last dose (approximately week 12)

,,
InterventionParticipants (Number)
SuccessFailureNonevaluable
Comparator8112
Daptomycin 6 mg/kg13101
Daptomycin 8 mg/kg1382

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Safety - Notable Laboratory Abnormalities

Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range. (NCT00428844)
Timeframe: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)

,,
InterventionParticipants (Number)
Hematocrit (<30%, >60%)Hemoglobin (<9,>19 g/dL)Red Blood Cell (Female <2.5,>6.0; Male <3.0, >6.5)White Blood Cell (<2, >20 x 10^9/L)Platelets (<40, >450 x 10^9/L)Albumin (<3, >6 g/dL)Alkaline Phosphatase (>1350 U/L)Alanine aminotransferase (>235 U/L)Aspartate aminotransferase (>185 U/L)Total bilirubin (>2.2 mg/dL)Blood Urea Nitrogen (>50 mg/dL)Creatinine (Female >2.0; Male>2.8 mg/dL)
Comparator151230104000012
Daptomycin 6 mg/kg121021137001021
Daptomycin 8 mg/kg101040134000000

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Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.

"Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.~Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation." (NCT00430937)
Timeframe: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks

,
InterventionParticipants (Number)
Microbiological SuccessMicrobiological Failure
Daptomycin561
Pooled Comparator394

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"Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population."

"Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).~Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy." (NCT00430937)
Timeframe: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks

,
InterventionParticipants (Number)
Clinical SuccessClinical Failure
Daptomycin535
Pooled Comparator416

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Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start

Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required. (NCT00463801)
Timeframe: at Day 7 and 14

InterventionParticipants (Number)
Daptomycin Intravenous0

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Clinical Response Within 48 Hours

Number of participants with clinical response within 48 hours from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 48 hours from initiating the study drug. (NCT00467272)
Timeframe: Within 48 hours from initiating the study drug

InterventionParticipants (Count of Participants)
Daptomycin 6 mg/kg IV28

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Clinical Response Within 7 Days

Number of participants with clinical response within 1 week from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 7 days from initiating the study drug. (NCT00467272)
Timeframe: Within 7 days from initiating the study drug

InterventionParticipants (Count of Participants)
Daptomycin 6 mg/kg IV33

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Microbiological Response Within 48 Hours

Number of participants with microbiological response within 48 hours from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures). (NCT00467272)
Timeframe: Within 48 hours from initiating the study drug

InterventionParticipants (Count of Participants)
Daptomycin 6 mg/kg IV29

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Microbiological Response Within 7 Days

Number of participants with microbiological response within 7 days from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures). (NCT00467272)
Timeframe: Within 7 days from initiating the study drug

InterventionParticipants (Count of Participants)
Daptomycin 6 mg/kg IV34

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Number of Participants With Overall Response

Overall response = symptom resolution within 3 days (since using antibiotic) + microbiological resolution within 3 days + no infection-related death + no infection-related late complications + no relapse. Infection-related late complication was defined as the development of deep-seated infection that was not present or suspected at the onset of bacteremia but was subsequently diagnosed after 1 week from initiation of study drug. (NCT00467272)
Timeframe: Within 3 days from initiating the study drug

InterventionParticipants (Count of Participants)
Daptomycin 6 mg/kg IV25

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Relapse

Number of participants with relapse was defined as the recurrence of bacteremia within the first 3 months. (NCT00467272)
Timeframe: Within 3 months from initiating the study drug

InterventionParticipants (Count of Participants)
Daptomycin 6 mg/kg IV3

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Summary of the Investigator's Assessment of Clinical Response at the TOC Visit

TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved. (NCT00638157)
Timeframe: TOC Visit

,
InterventionParticipants (Number)
TC (clinical cure, microbiological success)TC (clinical cure, microbiological nonevaluable)TF (clinical failure, microbiological success)TF (clinical cure, microbiological failure)TF (clinical failure, microbiological failure)TF (clinical improved, microbiological failure)TF (clinical failure, microbiological nonevaluableTI (clinical improved, microbiological success)TI (clin improved, microbiological nonevaluable)Non-evaluable
Daptomycin4010200002
Daptomycin Plus Gentamicin5010002102

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Summary of Clinically Significant Increases in Serum Creatinine by Visit

The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL. (NCT00638157)
Timeframe: Baseline, EOT Visit, TOC

,
InterventionParticipants (Number)
Baseline - Any ElevationBaseline - No ElevationEnd of Therapy - Any ElevationEnd of Therapy - No ElevationTest of Cure - Any Elevation (n=8,9)Test of Cure - No Elevation (n=8,9)
Daptomycin01001008
Daptomycin Plus Gentamicin01221027

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Daptomycin Volume of Distribution at Steady State

Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body. (NCT00663403)
Timeframe: From time of daptomycin administration to 48 hours post dose

InterventionL/kg (Mean)
Daptomycin in Continuous Renal Replacement Therapy (CRRT)0.23

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Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis

Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis. (NCT00663403)
Timeframe: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

InterventionmL/min (Mean)
Daptomycin in Continuous Renal Replacement Therapy (CRRT)6.3

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Daptomycin Total Body Clearance

Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver. (NCT00663403)
Timeframe: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

InterventionmL/min/kg (Mean)
Daptomycin in Continuous Renal Replacement Therapy (CRRT)0.13

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Daptomycin Half-life

Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half. (NCT00663403)
Timeframe: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Interventionhours (Mean)
Daptomycin in Continuous Renal Replacement Therapy (CRRT)20.8

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Daptomycin Free Fraction

"In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the free component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria." (NCT00663403)
Timeframe: From time of daptomycin administration to 48 hours post dose

Interventionpercent protein binding (Mean)
Daptomycin in Continuous Renal Replacement Therapy (CRRT)17.5

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Daptomycin Dose Actually Administered

(NCT00663403)
Timeframe: Time of daptomycin administration

Interventionmg/kg (Mean)
Daptomycin in Continuous Renal Replacement Therapy (CRRT)7.7

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Observed Daptomycin Peak Serum Concentration

The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min. (NCT00663403)
Timeframe: At the end of the daptomycin intravenous infusion (at approximately 30 minutes)

Interventionug/mL (Mean)
Daptomycin in Continuous Renal Replacement Therapy (CRRT)81.2

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Number of Participants With Treatment Cure at End of Therapy (EOT) Visit

Investigator's assessment of treatment cure. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy. (NCT00695903)
Timeframe: End of Therapy (median day 12 and 6.5 in daptomycin and vancomycin modified intent-to treat population, respectively)

Interventionparticipants (Number)
Daptomycin 10 mg/kg6
Vancomycin High-dose3

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Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit

Investigator's assessment of clinical response. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy. (NCT00695903)
Timeframe: Test of Cure (TOC) Visit (35 to 49 days post-therapy, approximately week 8)

Interventionparticipants (Number)
Daptomycin 10 mg/kg5
Vancomycin High-dose3

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Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations

Number of participants with treatment-emergent CPK elevations ≥5 x upper limit of normal (≥1,000 U/L) by the EOT visit. (NCT00695903)
Timeframe: On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)

InterventionParticipants (Number)
Daptomycin 10 mg/kg2
Vancomycin High-dose0

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Number of Participants With Elevated Serum Creatinine

Number of participants with treatment-emergent serum creatinine increases ≥0.5 mg/dL (for patients with a baseline value ≤3.0 mg/dL) or ≥1.0 mg/dL (for patients with a baseline value >3.0 mg/dL) by the EOT visit. (NCT00695903)
Timeframe: On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)

Interventionparticipants (Number)
Daptomycin 10 mg/kg0
Vancomycin High-dose4

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Mean Daptomycin Concentrations at 12, 18, 24, and 48 h

Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h (NCT00701636)
Timeframe: Hospital discharge or 7 days, whichever comes first

Interventionmcg/ml (Mean)
mean daptomycin concentration at 12 hoursmean daptomycin concentration at 18 hoursmean daptomycin concentration at 24 hoursmean daptomycin concentration at 48 hours
Cases22.716.212.03.5

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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

"A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included possibly related or related as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module." (NCT00711802)
Timeframe: Baseline through 14 days after last dose of study drug

,,,,,,,
Interventionpercentage of participants (Number)
At least 1 TEAEAt least 1 drug-related TEAEDiscontinued treatment due to a TEAE
Age Group 1: Daptomycin36.113.92.8
Age Group 1: Standard of Care (SOC)36.810.50
Age Group 2: Daptomycin23.35.51.4
Age Group 2: SOC18.410.50
Age Group 3: Daptomycin50.622.23.7
Age Group 3: SOC38.121.414.3
Age Group 4: Daptomycin46.710.03.3
Age Group 4: SOC73.333.36.7

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Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit

"The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as Success or Failure by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered Success by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of Failure was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was Failure. If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was Unable to evaluate." (NCT00711802)
Timeframe: Baseline through 14 days after last dose of study drug

,,,,,,,
Interventionpercentage of participants (Number)
Clinical successClinical failureUnable to evaluate
Age Group 1: Daptomycin95.904.1
Age Group 1: Standard of Care (SOC)91.92.75.4
Age Group 2: Daptomycin90.42.76.9
Age Group 2: SOC92.107.9
Age Group 3: Daptomycin82.71.216.1
Age Group 3: SOC76.2023.8
Age Group 4: Daptomycin80.0020.0
Age Group 4: SOC86.7013.3

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Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])

"Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points:~Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion." (NCT00711802)
Timeframe: Predose and 5 timepoints according to age group (up to 12 hours postdose)

Interventionmicrogram*hour per milliliter (μg*hr/mL) (Mean)
Age Group 1: Daptomycin318
Age Group 2: DaptomycinNA
Age Group 3: Daptomycin318
Age Group 4: Daptomycin466

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Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC

"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen." (NCT00770341)
Timeframe: 7-14 days for SSTI, 14-42 days for septicemia and RIE

InterventionParticipants (Number)
MK-3009 (Daptomycin) 4 mg/kg31
Vancomycin9
MK-3009 (Daptomycin) 6 mg/kg2

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Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)

"Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT).~MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline." (NCT00770341)
Timeframe: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)

InterventionParticipants (Number)
MK-3009 (Daptomycin) 4 mg/kg45
Vancomycin16
MK-3009 (Daptomycin) 6 mg/kg2

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EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).

"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen." (NCT00770341)
Timeframe: 7-14 days for SSTI, 14-42 days for septicemia and RIE

InterventionParticipants (Number)
MK-3009 (Daptomycin) 4 mg/kg24
Vancomycin9
MK-3009 (Daptomycin) 6 mg/kg4

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EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).

Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. (NCT00770341)
Timeframe: 7-14 days for SSTI, 14-42 days for septicemia and RIE

InterventionParticipants (Number)
MK-3009 (Daptomycin) 4 mg/kg46
Vancomycin16
MK-3009 (Daptomycin) 6 mg/kg2

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Study Investigators' Assessment of Clinical Response at TOC

Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. (NCT00770341)
Timeframe: 7-14 days for SSTI, 14-42 days for septicemia and RIE

InterventionParticipants (Number)
MK-3009 (Daptomycin) 4 mg/kg48
Vancomycin17
MK-3009 (Daptomycin) 6 mg/kg2

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Study Investigators' Assessment of Clinical Response at EOT

Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. (NCT00770341)
Timeframe: 7-14 days for SSTI, 14-42 days for septicemia and RIE

InterventionParticipants (Number)
MK-3009 (Daptomycin) 4 mg/kg47
Vancomycin18
MK-3009 (Daptomycin) 6 mg/kg3

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Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)

The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective) (NCT00772447)
Timeframe: baseline and EOT(end of therapy), for up to 2 weeks

InterventionPercentage of patients (Number)
Daptomycin90.9
Vancomycin, or Vancomycin Switch to Cloxacillin91.3

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Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)

The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective) (NCT00772447)
Timeframe: baseline and TOC, for up to 4 weeks

Interventionpercentage of patients (Number)
Daptomycin93.5
Vancomycin, or Vancomycin Switch to Cloxacillin90.1

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Change in Creatinine Clearance

(NCT00772447)
Timeframe: baseline to TOC(test of cure), for up to 4 weeks

Interventionml/min (Mean)
Daptomycin9.91
Vancomycin, or Vancomycin Switch to Cloxacillin0.99

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Change in Serum Total Creatine Phosphokinase (CPK)

(NCT00772447)
Timeframe: baseline to TOC(test of cure), for up to 4 weeks

InterventionIU/L (Mean)
Daptomycin0.60
Vancomycin, or Vancomycin Switch to Cloxacillin-2.40

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Change in Urine pH

(NCT00772447)
Timeframe: baseline to TOC(test of cure), for up to 4 weeks

InterventionpH (Mean)
Daptomycin-0.19
Vancomycin, or Vancomycin Switch to Cloxacillin-0.30

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Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)

Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood (NCT00772447)
Timeframe: baseline to TOC(test of cure), for up to 4 weeks

Interventionpercentage (Mean)
Daptomycin0.00
Vancomycin, or Vancomycin Switch to Cloxacillin0.01

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Microbiological Response at EOT(End of Therapy)

The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline. (NCT00772447)
Timeframe: baseline and EOT, for up to 2 weeks

InterventionPercentage of strains (Number)
Daptomycin89.5
Vancomycin, or Vancomycin Switch to Cloxacillin87.5

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Microbiological Response at TOC(Test of Cure)

The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline. (NCT00772447)
Timeframe: baseline and TOC, for up to 4 weeks

InterventionPercentage of strains (Number)
Daptomycin94.0
Vancomycin, or Vancomycin Switch to Cloxacillin90.7

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Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)

This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups. (NCT00772447)
Timeframe: baseline and TOC, for up to 4 weeks

InterventionPercentage of patients (Number)
Daptomycin100
Vancomycin, or Vancomycin Switch to Cloxacillin90

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Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC

This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups. (NCT00772447)
Timeframe: baseline and TOC(test of cure), for up to 4 weeks

InterventionPercentage of patients (Number)
Daptomycin90.9
Vancomycin, or Vancomycin Switch to Cloxacillin89.2

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Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC

This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups. (NCT00772447)
Timeframe: baseline and TOC(test of cure), for up to 4 weeks

InterventionPercentage of patients (Number)
Daptomycin91.7
Vancomycin, or Vancomycin Switch to Cloxacillin87.5

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Shift in ECG

percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline (NCT00772447)
Timeframe: baseline to TOC(test of cure), for up to 4 weeks

Interventionpercentage of patients (Number)
Daptomycin5.4
Vancomycin, or Vancomycin Switch to Cloxacillin7.8

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Volume of Distribution

Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time. (NCT00882557)
Timeframe: Up to 68 hours post dose

InterventionmL/kg (Median)
6 mg/kg After Hemodialysis (Regimen B)137
9 mg/kg During Hemodialysis (Regimen A)145

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Clearance of Daptomycin

Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time. (NCT00882557)
Timeframe: Up to 68 hours post dose

InterventionmL/hr/kg (Median)
6 mg/kg After Hemodialysis (Regimen B)3.54
9 mg/kg During Hemodialysis (Regimen A)3.32

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Evaluation of Area Under the Curve From Time 0 to Infinity

Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses (NCT00882557)
Timeframe: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)

Interventionhr*ug/mL (Median)
6 mg/kg After Hemodialysis (Regimen B)1692
9 mg/kg During Hemodialysis (Regimen A)2708

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Half-life

Apparent terminal half-life. (NCT00882557)
Timeframe: Up to 68 hours post dose

InterventionHours (Median)
6 mg/kg After Hemodialysis (Regimen B)29.8
9 mg/kg During Hemodialysis (Regimen A)31.1

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Maximum Plasma Concentration

Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation. (NCT00882557)
Timeframe: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)

Interventionug/mL (Median)
6 mg/kg After Hemodialysis (Regimen B)70.5
9 mg/kg During Hemodialysis (Regimen A)100

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Time to Maximum Concentration

Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation. (NCT00882557)
Timeframe: Up to 68 hours post dose

InterventionHours (Median)
6 mg/kg After Hemodialysis (Regimen B)0.50
9 mg/kg During Hemodialysis (Regimen A)0.50

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Treatment-emergent Adverse Events

Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests. (NCT00882557)
Timeframe: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).

Interventionparticipants (Number)
6 mg/kg After Hemodialysis (Regimen B)2
9 mg/kg During Hemodialysis (Regimen A)3

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PK of Daptomycin

Area under the curve (NCT00942149)
Timeframe: 24 hours

Interventionmg*h/L (Median)
Area Under the Curve - 24 Hours262.4

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Maximum Plasma Concentration (Cmax)

(NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose

Interventionmg/L (Mean)
Daptomycin Hemodialysis42.4
Daptomycin Peritoneal Dialysis66.5

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Elimination Rate Constant (Ke)

(NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Interventionhr-1 (Mean)
Daptomycin Hemodialysis0.0053
Daptomycin Peritoneal Dialysis0.00848

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Drug Clearance Due to Dialysis (CLdialysis)

The rate at which a drug substance is removed from the body due to dialysis therapy (NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

InterventionmL/hr (Mean)
Daptomycin Hemodialysis670
Daptomycin Peritoneal Dialysis21

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Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)

(NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose

Interventionmg∙hr/L (Mean)
Daptomycin Hemodialysis557
Daptomycin Peritoneal Dialysis1051

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Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)

(NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose

Interventionmg∙hr/L (Mean)
Daptomycin Hemodialysis388
Daptomycin Peritoneal Dialysis708

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Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)

(NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Interventionmg∙hr/L (Mean)
Daptomycin Hemodialysis734
Daptomycin Peritoneal Dialysis1477

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Total Drug Clearance (CLtotal)

The rate at which a drug substance is removed from the body (NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

InterventionmL/hr (Mean)
Daptomycin Hemodialysis177
Daptomycin Peritoneal Dialysis170

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Volume of Distribution at Steady State (Vss)

The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug (NCT01012089)
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

InterventionL (Mean)
Daptomycin Hemodialysis5.89
Daptomycin Peritoneal Dialysis6.38

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Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit

"Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit:~Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication.~Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit.~Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator." (NCT01104662)
Timeframe: Baseline through TOC/Safety Visit

,,,,,,,
Interventionparticipants (Number)
SuccessFailureNon-evaluable
Daptomycin, Bacteremia, Moderate Renal Impairment121
Daptomycin, Bacteremia, Severe Renal Impairment924
Daptomycin, cSSSI, Moderate Renal Impairment500
Daptomycin, cSSSI, Severe Renal Impairment1032
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment301
Vancomycin or SSP, Bacteremia, Severe Renal Impairment916
Vancomycin or SSP, cSSSI, Moderate Renal Impairment420
Vancomycin or SSP, cSSSI, Severe Renal Impairment924

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Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)

The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented. (NCT01104662)
Timeframe: Baseline through EOT/ET

Interventionparticipants (Number)
Daptomycin, Bacteremia, Severe Renal Impairment0
Vancomycin or SSP, Bacteremia, Severe Renal Impairment1
Daptomycin, Bacteremia, Moderate Renal Impairment0
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment0
Daptomycin, cSSSI, Severe Renal Impairment1
Vancomycin or SSP, cSSSI, Severe Renal Impairment0
Daptomycin, cSSSI, Moderate Renal Impairment0
Vancomycin or SSP, cSSSI, Moderate Renal Impairment0

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Time Spent (Minutes) for Home Infusion Therapy

Each participant is counted once per category. Avg=average; Admin=administer. (NCT01175707)
Timeframe: Day 1 up to Day 14

,
InterventionMinutes (Mean)
Total antibiotic therapy durationTotal time to administer drugAvg time per day to administer drugAvg time to admin drug per infusionTotal caregiver time to admin drugAvg caregiver time per day to admin drugAvg caregiver time per infusion to admin drugTotal nursing timeAvg nursing time per visitAvg nursing time per dayTotal time for pharmacist consultations
Daptomycin160.787.66.646.64261.816.6616.66393.073.2573.9760.4
Vancomycin1430.11001.7127.7895.811336148.66124.25404.285.8087.7955.3

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Reasons for Pharmacist Consultations During Home Infusion Therapy

The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant. (NCT01175707)
Timeframe: Day 1 up to Day 14

,
InterventionReason Cited (Number)
Development/revision of care planReview of written reports of participant statusReview of related labs and other studiesCommunication - participantCommunication - prescriberCommunication - home care nurseCommunication - integration of new informationOther
Daptomycin251638382625313
Vancomycin252036372520413

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Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy

Each participant is counted once per category. (NCT01175707)
Timeframe: Day 1 up to Day 14

,
InterventionVisits or Consultations per Participant (Mean)
Total number of nursing visitsTotal number of scheduled nursing visitsTotal number of unscheduled nursing visitsTotal number of pharmacist consultations
Daptomycin5.84.14.919.6
Vancomycin5.04.41.249.6

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Reasons for Nurse Visits During Home Infusion Therapy

The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant. (NCT01175707)
Timeframe: Day 1 up to Day 14

,
InterventionReason Cited (Number)
Laboratory assessmentParticipant/Caregiver teachingSite/Catheter careClinical assessmentOther
Daptomycin36265128
Vancomycin362910219

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Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant

Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing. (NCT01175707)
Timeframe: Day 1 up to Day 14

,
InterventionUS Dollars (Mean)
Total Drug CostsPharmacy Service and Supplies CostsNursing CostsTotal Heartland CostsEmergency Room (ER) Visit CostsLost Work Costs
Daptomycin2762.37641.25637.633956.251660.313729.13
Vancomycin107.14596.25583.021273.0215183635.60

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Mean Number of Interventions Per Participant During Home Infusion Therapy

Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw. (NCT01175707)
Timeframe: Day 1 up to Day 14

InterventionInterventions (Mean)
Daptomycin1.8
Vancomycin1.5

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Number of Intervention Types During Home Infusion Therapy

There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention. (NCT01175707)
Timeframe: Day 1 up to Day 14

,
Interventionparticipants (Number)
IV line replacementIncision and drainage (wound)De-clotting procedureOther
Daptomycin2036
Vancomycin0122

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Number of Laboratory Assessment Types During Home Infusion Therapy

There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough (NCT01175707)
Timeframe: Day 1 up to Day 14

,
InterventionAssessments (Number)
Serum creatinineCPKVancomycin
Daptomycin40391
Vancomycin40038

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Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy

The mean duration in home-infusion antibiotic therapy per participant is presented. (NCT01175707)
Timeframe: Day 1 up to Day 14

InterventionDays (Mean)
Daptomycin13.0
Vancomycin11.0

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Percentage of Treatment Goals Met at End of Therapy

"Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic.~Each participant's percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants' percentage of goals met by arm." (NCT01175707)
Timeframe: Day 1 up to Day 14

InterventionPercentage of Goals Met (Mean)
Daptomycin74.98
Vancomycin75.21

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Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy

Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough. (NCT01175707)
Timeframe: Day 1 up to Day 14

InterventionParticipants (Number)
Daptomycin40
Vancomycin40

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Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy

(NCT01175707)
Timeframe: Day 1 up to Day 14

InterventionParticipants (Number)
Daptomycin40
Vancomycin40

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Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy

(NCT01175707)
Timeframe: Day 1 up to Day 14

InterventionParticipants (Number)
Daptomycin12
Vancomycin15

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Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy

Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough. (NCT01175707)
Timeframe: Day 1 up to Day 14

InterventionAssessments (Mean)
Daptomycin2.7
Vancomycin2.8

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Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit

Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy. (NCT01184872)
Timeframe: Baseline and 7 to 14 days after end of therapy

,
Interventionparticipants (Number)
SuccessFailure
Daptomycin658
Vancomycin or Semi-Synthetic Penicillins (SSPs)255

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Number of Patients With Adverse Events, Serious Adverse Events and Death

(NCT01184872)
Timeframe: Continuously from baseline up to 28 days after end of antibiotic treatment.

,
Interventionparticipants (Number)
Adverse EventsSerious Adverse EventsDeath
Daptomycin5070
Vancomycin or Semi-Synthetic Penicillins (SSPs)2640

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Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit

Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation. (NCT01184872)
Timeframe: Baseline and 7 to 14 days after end of therapy

,
Interventionparticipants (Number)
SuccessFailure
Daptomycin5411
Vancomycin or Semi-Synthetic Penicillins (SSPs)234

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Duration of Treatment (Intravenous)

Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days. (NCT01184872)
Timeframe: Up to 28 days

InterventionDays (Mean)
Daptomycin7.8
Vancomycin or Semi-Synthetic Penicillins (SSPs)7.3

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Duration of Treatment (Intravenous and Oral)

Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days. (NCT01184872)
Timeframe: Up to 28 days

,
InterventionDays (Mean)
intravenous onlyintravenous + oral
Daptomycin7.88.7
Vancomycin or Semi-Synthetic Penicillins (SSPs)7.39.6

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Antibiotic Days by Treatment Group

This will be analyzed by evaluating the difference in antibiotic days by treatment group and calculating 95% confidence intervals around the difference in antibiotic days among study patients randomized to algorithm-based treatment vs. among study patients randomized to standard treatment. (NCT01191840)
Timeframe: Test of cure 2 (up to approximately 42 days)

,
InterventionDays (Mean)
PP PopulationPPE Population
Algorithm-determined Therapy7.54.4
Standard of Care7.96.2

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Cure Rate

To compare the cure rate at Test of Cure evaluation, between the proposed treatment algorithm and the standard of care therapy. (NCT01191840)
Timeframe: Test of cure 2 (up to approximately 42 days)

InterventionParticipants (Count of Participants)
Standard of Care207
Algorithm-determined Therapy209

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Number of Participants With Serious Adverse Events

Number of Participants that reported a Serious Adverse Event (NCT01191840)
Timeframe: Test of cure 2 (up to approximately 42 days)

InterventionParticipants (Count of Participants)
Standard of Care72
Algorithm-determined Therapy83

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Number of Participants With Adverse Events Leading to Study Drug Withdrawal

Number of Participants with an Adverse Event leading to study drug withdrawal (NCT01191840)
Timeframe: Test of cure 2 (up to approximately 42 days)

InterventionParticipants (Count of Participants)
Standard of Care1
Algorithm-determined Therapy4

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Number of Participants That Changed From Vancomycin to Another Study Antibiotic Due to an Adverse Event

Patient changes from vancomycin or a protocol-approved study antibiotic to another protocol-approved study antibiotic due to AE associated with study drug (NCT01191840)
Timeframe: Test of cure 2 (up to approximately 42 days)

InterventionParticipants (Count of Participants)
Standard of Care2
Algorithm-determined Therapy5

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Percentage of Afebrile Neutropenic Subjects

To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops. (NCT01216241)
Timeframe: 5 days

Interventionparticipants (Number)
Daptomycin1
Saline Placebo1

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Number of Participants With Clinical Success at Test of Cure Visit.

Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy. (NCT01287832)
Timeframe: 30-42 days post-treatment

Interventionparticipants (Number)
High Dose Vancomycin4
High-dose Daptomycin3

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Participant Global Impression of Improvement (PGI-I) at Hospital Discharge

PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement. (NCT01419184)
Timeframe: End of Hospital Stay (up to Day 14)

Interventionunits on a scale (Mean)
Daptomycin2.05
Vancomycin1.80

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Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)

"Pain was measured as the amount of pain experienced right now by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain." (NCT01419184)
Timeframe: Baseline (Day 0), End of Hospital Stay (up to Day 14)

Interventionunits on a scale (Mean)
Daptomycin-2.08
Vancomycin-2.54

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Satisfaction of Discharge Criteria

RDTC cellulitis protocol discharge criteria (NCT01549613)
Timeframe: Time point at which outcome measure is assessed 30 days from the date of admission.

Interventionparticipants (Number)
Standard Treatment With Daptomycin15
Standard Treatment of Vancomycin14

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Percentage of Participants With Overall Success at TOC Visit

Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed. (NCT01728376)
Timeframe: 7-14 days after the last dose of study medication (up to 56 days)

InterventionPercentage of participants (Number)
Daptomycin - 1 to 6 Year Olds80.0
Comparator- 1 to 6 Year Olds75.0
Daptomycin - 7 to 11 Year Olds82.4
Comparator - 7 to 11 Year Olds44.4
Daptomycin - 12 to 17 Year Olds50.0
Comparator - 12 to 17 Year Olds60.0

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Percentage of Participants With Sustained CPK Elevations

Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN) (NCT01728376)
Timeframe: Baseline up to end of therapy visit (up to 44 days)

InterventionPercentage of Participants (Number)
Daptomycin - 1 to 6 Year Olds18.2
Comparator- 1 to 6 Year Olds20.0
Daptomycin - 7 to 11 Year Olds0.0
Comparator - 7 to 11 Year Olds0.0
Daptomycin - 12 to 17 Year Olds28.6
Comparator - 12 to 17 Year Olds14.3

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Trough Plasma Concentration of Daptomycin

Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded. (NCT01728376)
Timeframe: Days 3, 4, 5 or 6 of treatment at pre-dose

Interventionµg/mL (Mean)
Daptomycin - 1 to 6 Year Olds4.72
Daptomycin - 7 to 11 Year Olds6.39
Daptomycin - 12 to 17 Year Olds14.69

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Number of Participants With One or More Serious Adverse Events (SAEs)

An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event. (NCT01728376)
Timeframe: Administration of first dose through the last follow-up visit (up to 77 days)

InterventionParticipants (Number)
Daptomycin - 1 to 6 Year Olds6
Comparator- 1 to 6 Year Olds2
Daptomycin - 7 to 11 Year Olds4
Comparator - 7 to 11 Year Olds3
Daptomycin - 12 to 17 Year Olds3
Comparator - 12 to 17 Year Olds2

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Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)

Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers. (NCT01728376)
Timeframe: TOC Safety Visit (up to 56 days)

,,,,,
InterventionParticipants (Number)
AlertnessPupillary Reflex and TrackingPeripheral Reflex - BicepsPeripheral Reflex - Patellar TendonPeripheral Reflex - Ankle JerkPeripheral Reflex - Plantar ResponseMuscle Tone - Lower/Upper LimbsMuscle Strength - Lower/Upper LimbsCoordination - (Finger to Nose)Tremor of the hands/fingersSensation
Comparator - 12 to 17 Year Olds00000000000
Comparator - 7 to 11 Year Olds00000000000
Comparator- 1 to 6 Year Olds00000000000
Daptomycin - 1 to 6 Year Olds00000000000
Daptomycin - 12 to 17 Year Olds00000022000
Daptomycin - 7 to 11 Year Olds01011000010

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Percentage of Participants With Clinical Success at TOC/Safety Visit

Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study. (NCT01728376)
Timeframe: 7-14 days after the last dose of study medication (up to 56 days)

,,,,,
InterventionPercentage of participants (Number)
CuredImproved
Comparator - 12 to 17 Year Olds60.00
Comparator - 7 to 11 Year Olds77.80
Comparator- 1 to 6 Year Olds87.50
Daptomycin - 1 to 6 Year Olds80.05.0
Daptomycin - 12 to 17 Year Olds78.67.1
Daptomycin - 7 to 11 Year Olds94.10

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Maximum Plasma Concentration (Cmax) of Daptomycin

Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded. (NCT01728376)
Timeframe: Days 3, 4, 5 or 6 of treatment at end of infusion

Interventionµg/mL (Mean)
Daptomycin - 1 to 6 Year Olds96.69
Daptomycin - 7 to 11 Year Olds87.66
Daptomycin - 12 to 17 Year Olds74.70

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Number of Participants With One or More Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT01728376)
Timeframe: Administration of first dose through the last follow-up visit (up to 77 days)

InterventionParticipants (Number)
Daptomycin - 1 to 6 Year Olds15
Comparator- 1 to 6 Year Olds6
Daptomycin - 7 to 11 Year Olds12
Comparator - 7 to 11 Year Olds9
Daptomycin - 12 to 17 Year Olds9
Comparator - 12 to 17 Year Olds5

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Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal

Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) . (NCT01728376)
Timeframe: Baseline up to end of therapy visit (up to 49 days)

InterventionPercentage of Participants (Number)
Daptomycin - 1 to 6 Year Olds40.9
Comparator- 1 to 6 Year Olds40.0
Daptomycin - 7 to 11 Year Olds10.5
Comparator - 7 to 11 Year Olds0.0
Daptomycin - 12 to 17 Year Olds28.6
Comparator - 12 to 17 Year Olds14.3

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Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity

"An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (< 0.5 ml/kg/hr x 6 hrs) while on the study drug.~This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group." (NCT01734694)
Timeframe: Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.

InterventionParticipants (Count of Participants)
Vancomycin16
Comparator16

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Proportion of Individuals With Nephrotoxicity

"Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.~This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group." (NCT01734694)
Timeframe: Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.

InterventionParticipants (Count of Participants)
Vancomycin5
Comparator3

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Plasma Concentration of Daptomycin at the End of IV Infusion

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42 (NCT01922011)
Timeframe: Day 3 up to Day 42

Interventionµg/mL (Mean)
Daptomycin 12 - < 24 Months Old36.800
Daptomycin 24 Months - < 7 Yrs Old75.772
Daptomycin 7 - < 12 Yrs Old58.940
Daptomycin 12 - < 18 Yrs Old68.907

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Concentration of Serum Creatine Kinase (CK)

Serum was collected at Baseline and at End of Therapy IV, from which the concentration of CK was determined. (NCT01922011)
Timeframe: Baseline and End of Therapy IV (up to Day 42)

,
InterventionU/L (Mean)
Baseline (n = 68,72)End of Therapy IV (n= 35,41)
Daptomycin141.789.4
Vancomycin or Nafcillin99.982.4

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Percentage of Participants With a Clinical Cure Categorized by Baseline Pathogen at Test of Cure

At Test Of Cure (TOC) clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further antibacterial therapy is required. Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. To have a favorable microbiological response, the outcome for each participant's baseline pathogen must be favorable (eradicated or presumed eradicated). Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes. (NCT01922011)
Timeframe: Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

,
InterventionPercentage of participants (Number)
Overall Baseline Infecting Pathogen (n =45,47)Staphylococcus Aureus (SA) (n= 43,42)Methicillin Susceptible SA (MSSA) (n= 39,37)Methicillin Resistant SA (MRSA) (n= 4,4)Other Pathogens (n= 2,7)
Daptomycin77.876.779.550.0100
Vancomycin or Nafcillin87.288.194.625.085.7

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Percentage of Participants With a Favorable Clinical Outcome

Favorable clinical outcomes are clinical recovery and clinical cure. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. Clinical recovery is defined as clinical improvement in the composite end point three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5, and no development of new symptoms of AHO; body temperature ≤ 38°C (100.4°F) for 24 hours; no new or additional bone or joint infection (e.g., abscess, spreading to other osseous or articular locations) such that no further antibacterial therapy or surgery are required; no hematogenous metastatic infection (e.g., abscess in liver, spleen, lung; other bones) or bacteremia.. The End of Therapy (EOT) visit is within 48 hours of last dose of PO therapy. (NCT01922011)
Timeframe: Baseline (within 48 hours prior to first dose of IV study drug) - and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

,
InterventionPercentage of participants (Number)
At End of IV (EOIV) Therapy (n= 71,69)At End of Therapy (EOT) (n= 71,69)At Test Of Cure (TOC) (n= 71,70)
Daptomycin85.983.181.7
Vancomycin or Nafcillin91.389.987.1

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Percentage of Participants With a Favorable Microbiological Response Categorized by Baseline Pathogen at Test of Cure

Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. For a favorable microbiological response, the outcome for each baseline pathogen must be eradicated or presumed eradicated. Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes. (NCT01922011)
Timeframe: Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

,
InterventionPercentage of participants (Number)
Overall Baseline Infecting Pathogen (n =45,47)SA (n= 43,42)MSSA (n= 39,37)MRSA (n= 4,4)Other Pathogens (n= 2,7)
Daptomycin82.281.484.650.0100
Vancomycin or Nafcillin91.592.994.675.085.7

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Percentage of Participants With Sustained Clinical Improvement

Sustained clinical improvement was defined as participants with clinical improvement who further met the definition of clinical cure. Clinical improvement was in the three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. The EOT visit is within 48 hours of last dose of PO therapy. (NCT01922011)
Timeframe: Baseline (within 48 hours prior to first dose of IV study drug) - up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

,
InterventionPercentage of participants (Number)
EOT (n= 55,57)TOC (n= 55,58)
Daptomycin89.187.3
Vancomycin or Nafcillin94.791.4

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Number of Participants With 1 or More Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, clinically significant laboratory finding, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (NCT01922011)
Timeframe: Administration of first dose up to approximately six and a half months after last dose of study drug

InterventionParticipants (Number)
Daptomycin34
Vancomycin or Nafcillin45

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Number of Participants With 1 or More Serious Adverse Events (SAEs)

An SAE is any untoward medical occurrence that at any dose results in death; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect. (NCT01922011)
Timeframe: Administration of first dose through the last follow-up visit; an expected time of up to 6.5 months

InterventionParticipants (Number)
Daptomycin5
Vancomycin or Nafcillin4

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Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories.

Clinical improvement was based on the Investigator's overall assessment of severity of each of the 3 general symptom categories of Pain, Inflammation, and Limb Function. Based on this evaluation, a participant was considered to have met criteria for clinical improvement according to the following definition: If 3 general categories are present at baseline: at least a 1-point improvement (i.e. severe to moderate, moderate to mild, mild to absent) in at least 2 of the general categories and no worsening in the other. If 2 general categories are present at baseline: at least a 2-point improvement (i.e. severe to mild, moderate to absent) in at least 1 of the general categories and no worsening or new findings in the others OR at least a 1-point improvement in both and no new findings in the other. If 1 general category is present at baseline: at least a 2-point improvement (i.e., severe to mild, moderate to absent) in that category and no new findings in the others. (NCT01922011)
Timeframe: Up to study Day 5

InterventionPercentage of participants (Number)
Daptomycin77.5
Vancomycin or Nafcillin82.9

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Percentage of Participants With Clinical Improvement Measured as a Composite End Point of Pain, Inflammation, Limb Function, Body Temperature, and C-reactive Protein at End-of IV (EOIV) Therapy Visit.

A participant had a favorable outcome in this composite endpoint if all 3 of the following criteria were met: Clinical improvement in the general symptom categories of Pain, Inflammation, and Limb Function on or before Study Day 5; Body temperature ≤ 38°C (100.4°F) over the preceding 24 hours; and C-reactive Protein (CRP) decreased from baseline for participants who had a baseline CRP >ULN (upper limit of normal)) or remain <=ULN for participants who had a baseline <=ULN on or before Study Day 5. The EOIV visit is within 24 hours after the last dose of IV study drug and before switch to optional open label (PO) therapy, if applicable. (NCT01922011)
Timeframe: Up to study Day 5

InterventionPercentage of participants (Number)
Daptomycin71.0
Vancomycin or Nafcillin76.5

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Plasma Concentration of Daptomycin at 15 Minutes to 1 Hour After the End of IV Infusion

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42 (NCT01922011)
Timeframe: Day 3 up to Day 42

Interventionµg/mL (Mean)
Daptomycin 12 - < 24 Months Old65.533
Daptomycin 24 Months - < 7 Yrs Old84.564
Daptomycin 7 - < 12 Yrs Old70.342
Daptomycin 12 - < 18 Yrs Old57.370

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Plasma Concentration of Daptomycin at 2 to 3 Hours After the End of IV Infusion

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42 (NCT01922011)
Timeframe: Day 3 up to Day 42

Interventionµg/mL (Mean)
Daptomycin 24 Months - < 7 Yrs Old51.150
Daptomycin 7 - < 12 Yrs Old31.200
Daptomycin 12 - < 18 Yrs Old46.756

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Plasma Concentration of Daptomycin at 4 to 5 Hours After the End of IV Infusion

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42 (NCT01922011)
Timeframe: Day 3 up to Day 42

Interventionµg/mL (Mean)
Daptomycin 12 - < 24 Months Old35.933
Daptomycin 24 Months - < 7 Yrs Old53.059
Daptomycin 7 - < 12 Yrs Old50.809
Daptomycin 12 - < 18 Yrs Old41.447

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Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population

This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response (NCT02208063)
Timeframe: Up to 8 weeks

,
InterventionParticipants (Count of Participants)
SuccessFailureIndeterminateMissing
Standard of Care361501
Telavancin281351

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Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)

"The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).~Alive at TOC~Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC~No evidence of microbiological persistence of relapse~No new foci of metastatic S. aureus infection after Day 8" (NCT02208063)
Timeframe: Up to 8 weeks

,
InterventionParticipants (Count of Participants)
CureFailureIndeterminate
Standard of Care27214
Telavancin22196

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Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population

"The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:~Subject alive at TOC~Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)~No evidence of microbiological persistence or relapse~No new foci of metastatic S. aureus infection after Day 8" (NCT02208063)
Timeframe: Up to 8 weeks

,
InterventionParticipants (Count of Participants)
CureFailureIndeterminateMissing
Standard of Care311902
Telavancin261533

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Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations

After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection (NCT02208063)
Timeframe: Day 8

,
InterventionParticipants (Count of Participants)
YesNoIndeterminate
Standard of Care3418
Telavancin6329

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Number of Patients With Microbiological Eradication at the PTE Visit

Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE. (NCT03138733)
Timeframe: At PTE visit on Day 70 (± 5 days) post-randomization

InterventionParticipants (Count of Participants)
Ceftobiprole155
Daptomycin153

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Time to Staphylococcus Aureus Bloodstream Clearance

Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection (NCT03138733)
Timeframe: Up to 6 weeks post-randomization

InterventionDays (Median)
Ceftobiprole4
Daptomycin4

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All-cause Mortality at the PTE Visit

Comparison of all-cause mortality rates in the mITT population (NCT03138733)
Timeframe: At PTE visit on Day 70 (± 5 days) post-randomization

,
InterventionParticipants (Count of Participants)
Patients diedPatients alive
Ceftobiprole17172
Daptomycin18180

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Number of Patients With or Without Adverse Events (AEs)

Treatment-emergent adverse events in the safety population (NCT03138733)
Timeframe: AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days)

,
InterventionParticipants (Count of Participants)
Any adverse events (AEs)Any drug-related AEAny severe AEsAny study drug-related severe AEsAny serious adverse events (SAE)Any drug-related SAEsAny AE leading to treatment discontinuationStudy drug-related AEs leading to treatment discontinuationAny AE leading to deathStudy drug-related AEs leading to deathAny AE of special interest (AESI)Any drug-related AESI
Ceftobiprole1212529136218917095
Daptomycin1171138245418318074

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Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit

"Comparison of overall success rates in the mITT population~Overall success at PTE for the mITT population was defined as all of the following criteria being met (Responder):~Patient alive at Day 70 (± 5 days) post-randomization.~No new metastatic foci or complications of the SAB infection.~Resolution or improvement of SAB-related clinical signs and symptoms.~Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)" (NCT03138733)
Timeframe: PTE visit on Day 70 (± 5 days) post-randomization

,
InterventionParticipants (Count of Participants)
Number of respondersNumber of non-responders
Ceftobiprole13257
Daptomycin13662

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Number of Patients With or Without Overall Success at the PTE Visit in the CE Population

"Comparison of overall success rates in the Clinical Evaluable (CE) population~Overall success at PTE for the CE population was defined as all of the following criteria being met (Responder):~Patient alive at Day 70 (± 5 days) post-randomization.~No new metastatic foci or complications of the SAB infection.~Resolution or improvement of SAB-related clinical signs and symptoms.~Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)" (NCT03138733)
Timeframe: At PTE visit on Day 70 (± 5 days) post-randomization

,
InterventionParticipants (Count of Participants)
Number of respondersNumber of non-responders
Ceftobiprole12736
Daptomycin13037

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Maximum Plasma Concentration (Cmax) of Daptomycin

Blood samples were collected at pre-specified timepoints to determine Cmax of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

Interventionμg/mL (Mean)
Age Category 1-<2 yearsAge Category 7-11 yearsAge Category 12-17 years
Daptomycin (Bacteremia)10473.194.0

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Body Weight Adjusted Clearance (CLss/wt) of Daptomycin

Blood samples were collected at pre-specified time points to determine CLss/wt of daptomycin at steady state. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionmL/hr/kg (Mean)
Age Category 1-<2 YearsAge Category 2-6 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (cSSTI)17.821.119.415.8

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Body Weight Adjusted Clearance (CLss/wt) of Daptomycin

Blood samples were collected at pre-specified time points to determine CLss/wt of daptomycin at steady state. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionmL/hr/kg (Mean)
Age Category 1-<2 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (Bacteremia)23.915.016.6

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Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin

Blood samples were collected at pre-specified time points to determine the AUC0-24 of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

Interventionµg·hr/mL (Mean)
Age Category 1-<2 yearsAge Category 2-6 yearsAge Category 7-11 yearsAge Category 12-17 years
Daptomycin (cSSTI)574431409316

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Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin

Blood samples were collected at pre-specified time points to determine the AUC0-24 of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

Interventionµg·hr/mL (Mean)
Age Category 1-<2 yearsAge Category 7-11 yearsAge Category 12-17 years
Daptomycin (Bacteremia)502599422

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Apparent Terminal Half-Life (t½) of Daptomycin

Blood samples were collected at pre-specified time points to determine the t½ of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionHours (Mean)
Age Category 1-<2 YearsAge Category 2-6 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (cSSTI)4.943.875.075.71

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Apparent Terminal Half-Life (t½) of Daptomycin

Blood samples were collected at pre-specified time points to determine the t½ of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionHours (Mean)
Age Category 1-<2 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (Bacterermia)4.465.853.98

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Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response

Participant-level microbiological response in participants with MRSA infections at baseline is defined as absence or presumed absence of all baseline infecting pathogens AND no gram-positive superinfection or gram-positive new infection, as assessed by infection site specimen culture or blood culture. (NCT03643952)
Timeframe: Up to 7 days following end of treatment (up to 49 days)

InterventionPercentage of Participants (Number)
Daptomycin (MRSA With cSSTI)71.4
Daptomycin (MRSA With Bacteremia)100

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Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success

"Clinical success in participants with MRSA infections was defined as either Cure - Resolution of clinically significant signs and symptoms associated with admission infection and no further antibiotic therapy required, OR Improved- partial resolution of clinical signs or symptoms of infection with no further antibiotic therapy required." (NCT03643952)
Timeframe: Up to 7 days following end of treatment (up to 49 days)

InterventionPercentage of Participants (Number)
Daptomycin (MRSA With cSSTI)85.7
Daptomycin (MRSA With Bacteremia)100

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Time to Maximum Plasma Concentration (Tmax) of Daptomycin

Blood samples were collected at pre-specified time points to determine Tmax of daptomycin (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionHours (Median)
Age Category 1-<2 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (Bacteremia)1.270.8000.733

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Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE)

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT03643952)
Timeframe: Up to 42 days

InterventionPercentage of Participants (Number)
Daptomycin0

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Volume of Distribution at Steady State (Vss) of Daptomycin

Blood samples were collected at pre-specified time points to determine Vss (mL) of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionmL (Mean)
Age Category 1-<2 YearsAge Category 2-6 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (cSSTI)1146175339296414

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Volume of Distribution at Steady State (Vss) of Daptomycin

Blood samples were collected at pre-specified time points to determine Vss (mL) of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionmL (Mean)
Age Category 1-<2 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (Bacteremia)191840135106

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Time to Maximum Plasma Concentration (Tmax) of Daptomycin

Blood samples were collected at pre-specified time points to determine Tmax of daptomycin (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

InterventionHours (Median)
Age Category 1-<2 YearsAge Category 2-6 YearsAge Category 7-11 YearsAge Category 12-17 Years
Daptomycin (cSSTI)1.331.230.8330.750

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Percentage of Participants With an Adverse Event

An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT03643952)
Timeframe: Up to 56 days

InterventionPercentage of Participants (Number)
Daptomycin55.6

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Maximum Plasma Concentration (Cmax) of Daptomycin

Blood samples were collected at pre-specified timepoints to determine Cmax of daptomycin. (NCT03643952)
Timeframe: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

Interventionμg/mL (Mean)
Age Category 1-<2 yearsAge Category 2-6 yearsAge Category 7-11 yearsAge Category 12-17 years
Daptomycin (cSSTI)91.780.364.449.3

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