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

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

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700. Ampicillin-Ceftriaxone Versus Ampicillin-Gentamicin for Definitive Therapy of Enterococcus faecalis Infective Endocarditis: A Propensity Score-Matched,Retrospective Cohort Analysis

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.892 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S401-S401

Author(s):

Niyati H Shah ◽

Kathleen A Shutt ◽

Yohei Doi ◽

Yohei Doi

Keyword(s):

Infective Endocarditis ◽

Propensity Score ◽

Adverse Events ◽

Enterococcus Faecalis ◽

Treated Patient ◽

Cohort Analysis ◽

Hospital Readmissions ◽

The United States ◽

Antibiotic Regimen ◽

Definitive Therapy

Abstract Background The mortality rate for Enterococcus faecalis infective endocarditis (EIE) is high. Ampicillin-ceftriaxone (AC) has emerged as an alternative antibiotic regimen with lower toxicity compared to ampicillin-gentamicin (AG), but evidence regarding its success in reducing EIE-associated mortality in the United States is limited. We retrospectively compared mortality in EIE patients treated with AG versus AC. Methods We conducted a retrospective, propensity score-matched, cohort analysis of EIE patients treated with AG or AC from 2010 to 2017 at three hospitals in Pittsburgh, Pennsylvania. Patients were included in the analysis if they were treated for EIE with either AC or AG as the pathogen-directed antibiotic regimen for at least forty-eight hours. We assessed 90-day mortality as the primary outcome, and in-hospital mortality, length of hospital stay, hospital readmissions, adverse events, and relapse of bacteremia as the secondary outcomes. Results A total of 190 patients with EIE (100 treated with AC and 90 with AG) were included. Ninety-day mortality was significantly higher in the AC group than the AG group (21% vs 8%, p = 0.02). After propensity score-matching, 56 patients in each group remained for the outcomes analysis. We observed similar rates of 90-day mortality (6% vs 4%, p = 0.55), bacteremia relapse (0 patients in both cohorts), treatment failure (0% vs 1%, p = 0.50), and 90-day hospital readmission (24% vs 23%, p = 0.85) in the AC and AG-treated patient cohorts. Adverse events were more common in patients treated with AG, and more patients in the AG cohort switched antibiotic regimens than in the AC group. Conclusion EIE patients treated with AC have similar mortality rates as those treated with AG, while AG is associated with increased toxicity and adverse events. Larger, multi-center studies are still needed to compare the two antibiotic regimens. Disclosures All Authors: No reported disclosures

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The Association of Intraoperative driving pressure with postoperative pulmonary complications in open versus closed abdominal surgery patients – a posthoc propensity score–weighted cohort analysis of the LAS VEGAS study

BMC Anesthesiology ◽

10.1186/s12871-021-01268-y ◽

2021 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Guido Mazzinari ◽

◽

Ary Serpa Neto ◽

Sabrine N. T. Hemmes ◽

Goran Hedenstierna ◽

...

Keyword(s):

Propensity Score ◽

Adverse Events ◽

Abdominal Surgery ◽

Las Vegas ◽

Cohort Analysis ◽

Risk Difference ◽

Pulmonary Complications ◽

Driving Pressure ◽

Postoperative Pulmonary Complications ◽

Open Abdominal Surgery

Abstract Background It is uncertain whether the association of the intraoperative driving pressure (ΔP) with postoperative pulmonary complications (PPCs) depends on the surgical approach during abdominal surgery. Our primary objective was to determine and compare the association of time–weighted average ΔP (ΔPTW) with PPCs. We also tested the association of ΔPTW with intraoperative adverse events. Methods Posthoc retrospective propensity score–weighted cohort analysis of patients undergoing open or closed abdominal surgery in the ‘Local ASsessment of Ventilatory management during General Anaesthesia for Surgery’ (LAS VEGAS) study, that included patients in 146 hospitals across 29 countries. The primary endpoint was a composite of PPCs. The secondary endpoint was a composite of intraoperative adverse events. Results The analysis included 1128 and 906 patients undergoing open or closed abdominal surgery, respectively. The PPC rate was 5%. ΔP was lower in open abdominal surgery patients, but ΔPTW was not different between groups. The association of ΔPTW with PPCs was significant in both groups and had a higher risk ratio in closed compared to open abdominal surgery patients (1.11 [95%CI 1.10 to 1.20], P < 0.001 versus 1.05 [95%CI 1.05 to 1.05], P < 0.001; risk difference 0.05 [95%CI 0.04 to 0.06], P < 0.001). The association of ΔPTW with intraoperative adverse events was also significant in both groups but had higher odds ratio in closed compared to open abdominal surgery patients (1.13 [95%CI 1.12– to 1.14], P < 0.001 versus 1.07 [95%CI 1.05 to 1.10], P < 0.001; risk difference 0.05 [95%CI 0.030.07], P < 0.001). Conclusions ΔP is associated with PPC and intraoperative adverse events in abdominal surgery, both in open and closed abdominal surgery. Trial registration LAS VEGAS was registered at clinicaltrials.gov (trial identifier NCT01601223).

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Association of Health Insurance Status with Outcomes of Sepsis in Adult Patients: A Retrospective Cohort Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18115777 ◽

2021 ◽

Vol 18 (11) ◽

pp. 5777

Author(s):

Gaon-Sorae Wang ◽

Kyoung-Min You ◽

You-Hwan Jo ◽

Hui-Jai Lee ◽

Jong-Hwan Shin ◽

...

Keyword(s):

Health Insurance ◽

Propensity Score ◽

Hospital Mortality ◽

Cohort Analysis ◽

Adult Patients ◽

Multivariate Logistic Regression Model ◽

Insurance Status ◽

Matched Cohort ◽

Health Insurance Status ◽

Significant Difference

(1) Background: Sepsis is a life-threatening disease, and various demographic and socioeconomic factors affect outcomes in sepsis. However, little is known regarding the potential association between health insurance status and outcomes of sepsis in Korea. We evaluated the association of health insurance and clinical outcomes in patients with sepsis. (2) Methods: Prospective cohort data of adult patients with sepsis and septic shock from March 2016 to December 2018 in three hospitals were retrospectively analyzed. We categorized patients into two groups according to their health insurance status: National Health Insurance (NHI) and Medical Aid (MA). The primary end point was in-hospital mortality. The multivariate logistic regression model and propensity score matching were used. (3) Results: Of a total of 2526 eligible patients, 2329 (92.2%) were covered by NHI, and 197 (7.8%) were covered by MA. The MA group had fewer males, more chronic kidney disease, more multiple sources of infection, and more patients with initial lactate > 2 mmol/L. In-hospital, 28-day, and 90-day mortality were not significantly different between the two groups and in-hospital mortality was not different in the subgroup analysis. Furthermore, health insurance status was not independently associated with in-hospital mortality in multivariate analysis and was not associated with survival outcomes in the propensity score-matched cohort. (4) Conclusion: Our propensity score-matched cohort analysis demonstrated that there was no significant difference in in-hospital mortality by health insurance status in patients with sepsis.

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Clinical evaluation of two adult oxygenator systems in terms of mortality and major adverse events

Perfusion ◽

10.1177/02676591211063830 ◽

2021 ◽

pp. 026765912110638

Author(s):

Hüsnü Kamil Limandal ◽

Mehmet Ali Kayğın ◽

Servet Ergün ◽

Taha Özkara ◽

Mevriye Serpil Diler ◽

...

Keyword(s):

Adverse Events ◽

Hospital Stay ◽

Artery Bypass ◽

Length Of Hospital Stay ◽

Fresh Frozen Plasma ◽

Wound Complications ◽

Significant Difference ◽

Delayed Sternal Closure ◽

Fresh Frozen ◽

Major Adverse Events

Purpose The primary aim of this study was to examine the effects of two oxygenator systems on major adverse events and mortality. Methods A total of 181 consecutive patients undergoing coronary artery bypass grafting in our clinic were retrospectively analyzed. The patients were divided into two groups according to the oxygenator used: Group M, in which a Medtronic Affinity (Medtronic Operational Headquarters, Minneapolis, MN, USA) oxygenator was used, and Group S, in which a Sorin Inspire (Sorin Group Italia, Mirandola, Italy) oxygenator was used. Results Group S consisted of 89 patients, whereas Group M included 92 patients. No statistically significant differences were found between the two groups in terms of age ( p = .112), weight ( p = .465), body surface area ( p = .956), or gender ( p = .484). There was no statistically significant difference in hemorrhage on the first or second postoperative day ( p = .318 and p = .455, respectively). No statistically significant differences were observed in terms of red blood cell ( p = .468), fresh frozen plasma ( p = .116), or platelet concentrate transfusion ( p = .212). Infections, wound complications, and delayed sternal closure were significantly more common in Group M ( p = .006, p = .023, and p = .019, respectively). Extracorporeal membrane oxygenators and intra-aortic balloon pumps were required significantly more frequently in Group S ( p = .025 and p = .013, respectively). Major adverse events occurred in 16 (18%) patients in Group S and 14 (15.2%) patients in Group M ( p = .382). Mortality was observed in six (6.7%) patients in Group S and three (3.3%) patients in Group M ( p = .232). No statistically significant difference was found between the two groups in terms of length of hospital stay ( p = .451). Conclusion The clinical outcomes of the two oxygenator systems, including mortality, major adverse events, hemorrhage, erythrocyte and platelet transfusions, and length of hospital stay, were similar.

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Early Oral Switch to Linezolid for Low-risk Patients With Staphylococcus aureus Bloodstream Infections: A Propensity-matched Cohort Study

Clinical Infectious Diseases ◽

10.1093/cid/ciy916 ◽

2018 ◽

Vol 69 (3) ◽

pp. 381-387 ◽

Cited By ~ 15

Author(s):

Rein Willekens ◽

Mireia Puig-Asensio ◽

Isabel Ruiz-Camps ◽

Maria N Larrosa ◽

Juan J González-López ◽

...

Keyword(s):

Staphylococcus Aureus ◽

Cohort Study ◽

Propensity Score ◽

Hospital Stay ◽

Propensity Score Matching ◽

Length Of Hospital Stay ◽

Low Risk ◽

Significant Difference ◽

Risk Patients ◽

Oral Switch

Abstract Background Oral switch to linezolid is a promising alternative to standard parenteral therapy (SPT) in Staphylococcus aureus bacteremia (SAB). Methods We conducted a prospective cohort study of all adult cases of SAB between 2013 and 2017 in a Spanish university hospital. We compared the efﬁcacy, safety, and length of hospital stay of patients receiving SPT and those where SPT was switched to oral linezolid between days 3 and 9 of treatment until completion. We excluded complicated SAB and osteoarticular infections. A k-nearest neighbor algorithm was used for propensity score matching with a 2:1 ratio. Results After propensity score matching, we included 45 patients from the linezolid group and 90 patients from the SPT group. Leading SAB sources were catheter related (49.6%), unknown origin (20.0%), and skin and soft tissue (17.0%). We observed no difference in 90-day relapse between the linezolid group and the SPT group (2.2% vs 4.4% respectively; P = .87). No statistically significant difference was observed in 30-day all-cause mortality between the linezolid group and the SPT group (2.2% vs 13.3%; P = .08). The median length of hospital stay after onset was 8 days in the linezolid group and 19 days in the SPT group (P < .01). No drug-related events leading to discontinuation were noted in the linezolid group. Conclusions Treatment of SAB in selected low-risk patients with an oral switch to linezolid between days 3 and 9 of treatment until completion yielded similar clinical outcomes as SPT, allowing earlier discharge from the hospital.

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1599. Clinical Outcomes for Patients Treated with Fluoroquinolones for Bacteremia Caused by Enterobacteriaceae Reclassified as Not Susceptible by Updated CLSI Breakpoints

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1779 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S796-S796

Author(s):

Zachary Fleischner ◽

Wendy Szymczak ◽

Gregory Weston

Keyword(s):

Primary Outcome ◽

Length Of Hospital Stay ◽

The United States ◽

Empiric Therapy ◽

Research Support ◽

Significant Difference ◽

Public Health Challenge ◽

Antibiotic Failure ◽

Susceptibility Breakpoint

Abstract Background Antibiotic resistance remains a pressing public health challenge. Antibiotic susceptibility testing is crucial to identify resistance and predict which antibiotics are most likely to be effective. In vitro minimum inhibitory concentrations (MICs) are interpreted using MIC breakpoints set for the United States by The Clinical and Laboratory Standards Institute (CLSI). In 2019 CLSI updated fluroquinolone (FQ) breakpoints for Enterobacteriaceae. Previously any isolate with an MIC ≤ 1 µg/mL of ciprofloxacin would be considered susceptible but based largely on pharmacokinetic/pharmacodynamic simulations the susceptibility breakpoint was revised to ≤ 0.25 µg/mL. However, the clinical relevance of this decision remains unclear. Methods All cases of Enterobacteriaceae bacteremia with isolates previously considered susceptible but reclassified as resistant (MIC = 1 µg/mL) in adults treated with FQs between 08/01/2018 and 07/31/2019 were identified. Demographics, clinical characteristics and outcomes were compared with an equal number of randomly selected isolates with an automated MIC reported as ≤ 0.5 µg/mL. Available stored isolates with a reported MIC of ≤ 0.5 µg/mL had manual E-testing performed to identify a more precise MIC. Results 29 cases with an MIC = 1 μg/mL were compared with 29 controls with a MIC of ≤ 0.5. Only 3 cases and 1 control received FQs as empiric therapy, the remaining patients in each group were transitioned to FQ after a median of 4 days of other antibiotics. No significant difference was found for predetermined outcomes including 30 day mortality, escalation after starting FQ, length of hospital stay, and readmission in 30 days (see Table). No primary outcome was thought to be related to antibiotic failure. E-testing found no isolates with an MIC = 0.5 μg/mL. Table 1 Conclusion Patients with Enterobacteriaceae bacteremia treated with FQs for isolates reclassified as resistant had similar outcomes to those with lower MICs. While FQs are generally not recommended as first line empiric antibiotics, FQs may still be safe to use as stepdown therapy for isolates with a ciprofloxacin MIC = 1 μg/mL, particularly if the only alternative may be IV antibiotics. A larger study is needed to confirm this. Disclosures Gregory Weston, MD MSCR, Allergan (Grant/Research Support)

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Outcomes With Severe Blastomycosis and Respiratory Failure in the United States

Clinical Infectious Diseases ◽

10.1093/cid/ciaa294 ◽

2020 ◽

Author(s):

Barret Rush ◽

Sylvain Lother ◽

Bojan Paunovic ◽

Owen Mooney ◽

Anand Kumar

Keyword(s):

Retrospective Cohort ◽

Cohort Analysis ◽

Ventilatory Support ◽

Case Series ◽

Length Of Hospital Stay ◽

Female Gender ◽

The United States ◽

Teaching Hospitals ◽

Historical Case ◽

Increased Risk

Abstract Background Outcomes of patients with severe pulmonary blastomycosis requiring mechanical ventilation (MV) are not well understood in the modern era. Limited historical case series reported 50–90% mortality in patients with acute respiratory distress syndrome caused by blastomycosis. The objective of this large retrospective cohort study was to describe the risk factors and outcomes of patients with severe pulmonary blastomycosis. Methods We performed a retrospective cohort analysis utilizing the Nationwide Inpatient Sample from 2006–2014. Patients aged >18 years with a diagnosis of blastomycosis who received MV were included. Results There were 1848 patients with a diagnosis of blastomycosis included in the study. Of these, 219 (11.9%) underwent MV with a mortality rate of 39.7% compared with 2.5% in patients not requiring ventilatory support (P < .01). The median (IQR) time to death for patients requiring MV was 12 (8–16) days. The median length of hospital stay for survivors of MV was 22 (14–37) days. The rate of MV was higher for patients treated in teaching hospitals (63.4% vs 57.2%, P = .05) and lower for those receiving care at a rural hospital (12.3% vs 17.2%, P = .04). In a multivariate model, female gender was associated with increased risk of mortality (OR, 1.84; 95% CI, 1.06–3.20; P = .03) as was increasing patient age (10-year age increase OR, 1.64; 95% CI, 1.33–2.02; P < .01). Conclusions In the largest published cohort of patients with blastomycosis, mortality for patients on MV is high at ~40%, 16-fold higher than those without MV.

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Nebulised hypertonic saline in moderate-to-severe bronchiolitis: a randomised clinical trial

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-317160 ◽

2019 ◽

Vol 105 (3) ◽

pp. 236-240 ◽

Cited By ~ 1

Author(s):

Raphaelle Jaquet-Pilloud ◽

Marie-Elise Verga ◽

Michel Russo ◽

Mario Gehri ◽

Jean-Yves Pauchard

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Hypertonic Saline ◽

Oxygen Therapy ◽

Length Of Hospital Stay ◽

Randomised Clinical Trial ◽

Chronic Respiratory Disease ◽

Primary Diagnosis ◽

Significant Difference ◽

Registration Number

ObjectivesTo investigate whether nebulised hypertonic saline (HS) treatment would decrease length of hospital stay (LOS) among infants with moderate-to severe-bronchiolitis compared with standard supportive care (SC).MethodsWe conducted an open, multicentre, randomised clinical trial from 1 April 2013 to 31 March 2016, in Swiss children’s hospitals. Patients aged 6 weeks to 24 months with a primary diagnosis of moderate or severe bronchiolitis were included. Children with previous episodes of wheezing, cardiac disease, chronic respiratory disease, immunodeficiency, prematurity (gestational age <34 weeks), corticotherapy in the preceding 2 weeks or inhaled bronchodilators within 24 hours before presentation were excluded. Patients were randomised to receive standard SC with nebulisation of 4 mL of 3% sodium chloride every 6 hours versus SSC. Main outcomes and measures were LOS duration of oxygen therapy, transfer to intensive care unit (ICU), readmission within 7 days following discharge and adverse events.Results121 children were randomised. No statistically significant differences were found between treatment groups at baseline (age, Wang Score, atopic history, smoking exposure). Children in the HS group had a non-significant difference in length of stay −2.8 hours (−10; 16) compared with the SC group. There were no differences in oxygen therapy duration, transfer to ICU, readmission rate or adverse events. The intervention was discontinued at the parents’ request in 16% of the cases.ConclusionOur study does not support the use of HS nebulisation in children with moderate to severe bronchiolitis.Trial registration numberNCT01812525.

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Abstract 16144: The Impact of Ventricular Pacing for Elderly Patients With Pacemaker Implantation: Over One Decade and Large Cohort Analysis

Circulation ◽

10.1161/circ.130.suppl_2.16144 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Ayako Kamijima ◽

Kohei Ishibashi ◽

Mitsuru Wada ◽

Ikutaro Nakajima ◽

Koji Miyamoto ◽

...

Keyword(s):

Adverse Events ◽

Elderly Patients ◽

Cohort Analysis ◽

Pacemaker Implantation ◽

The Elderly ◽

Ventricular Pacing ◽

Kaplan Meier ◽

Long Term Effect ◽

Significant Difference ◽

The Impact

Introduction: Previous studies showed that ventricular pacing (VP) increased the cardiac event of patients with pacemaker (PM). However, these studies consisted of patients under 75 years old and the influence of VP for elderly patients (over 75 years old) is still unclear. We sought to evaluate long-term effect of VP for elderly patients. Methods: A total of 782 patients (mean 57.2 years old) underwent PM implantation for brady-arrhythmia were enrolled from 1978 to 2005. The elderly patients (199 patients, over 75 years old, mean 80.7 years old) and all patients were divided into VP and non-VP group, and evaluated adverse events (death or readmission for heart failure). Results: The mean follow-up period was 10.1 years and 84 elderly patients (42%) developed adverse events. Kaplan-Meier analysis revealed that (1) VP increased the adverse event in all patients. (2) There was no significant difference in the adverse events of elderly patients between VP and non-VP group (Fig). Conclusion: VP may be tolerated for elderly patients with PM, whereas VP has no effect for the prognosis.

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Intraoperative Driving Pressure and Postoperative Pulmonary Complications After Abdominal Surgery – A Posthoc Propensity Score–Weighted Cohort Analysis of the LAS VEGAS Study Comparing Open to Closed Surgery

10.21203/rs.3.rs-107895/v1 ◽

2020 ◽

Author(s):

Guido Mazzinari ◽

Ary Serpa Neto ◽

Sabrine Hemmes ◽

Goran Hedenstierna ◽

Samir Jaber ◽

...

Keyword(s):

Propensity Score ◽

Adverse Events ◽

Abdominal Surgery ◽

Surgical Approach ◽

Las Vegas ◽

Cohort Analysis ◽

Pulmonary Complications ◽

Driving Pressure ◽

Postoperative Pulmonary Complications ◽

Open Abdominal Surgery

Abstract Background: It is uncertain whether associations between driving pressure (ΔP) during and occurrence of pulmonary complications after abdominal surgery depend on the surgical approach. Our primary objective was to test the time–weighted average ΔP (ΔPTW) association with postoperative pulmonary complications and our secondary objective was to test the association between ΔPTW and intraoperative Adverse Events. Methods: We realized a posthoc retrospective propensity score weighted cohort analysis of the ‘Local ASsessment of Ventilatory management during General Anesthesia for Surgery’ (LAS VEGAS) study including patients undergoing abdominal surgery from the study database including data from 146 hospitals across 29 countries. The primary endpoint was a composite of postoperative pulmonary complications. The secondary endpoint was the occurrence of intraoperative adverse events. Results: The analysis included 1,128 and 906 patients undergoing open or closed abdominal surgery repsectively. Absolute postoperative pulmonary complications rate was 5%. While driving pressure was lower in open abdominal surgery patients, time-weighted driving pressure was not different between groups. The association of ΔPTW with occurrence of postoperative pulmonary complications was significant in both groups, with a higher risk ratio in closed than in open abdominal surgery patients (1.11 [95%CI 1.10 to 1.20], P<0.001 vs. 1.05 [95% CI 1.05 to 1.05; P<0.001; risk difference 0.05: [95%CI 0.04 to 0.06], P<0.001). ΔPTW marginal effect estimation showed increased probability of pulmonary complication in both groups with a steeper increase in closed surgery patients at ΔPTW above 20 cmH2O∙hour-1. The association of ΔPTW with occurrence of intraoperative adverse events was also significant in both groups, with higher odds ratio in closed surgery (1.13 [95%CI 1.12 to 1.14]; P<0.001 vs. 1.07 [95%CI 1.05 to 1.10]; P<0.001; difference 0.05 [95%CI 0.03 to 0.07]; p<0.001). Conclusions: Our results show how driving pressure represents a marker for pulmonary complications and adverse events in abdominal surgery regardless of surgical approach.Trial registration: LAS VEGAS was registered at clinicaltrials.gov (trial identifier NCT01601223).

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