A Multicenter, Randomized, Parallel Group, Double-blind, Phase 2 Trial to Evaluate Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease

The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).

开始日期2016-09-28

申办/合作机构

SCM Lifescience Co., Ltd.

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100 项与 SCM CGH 相关的专利（医药）

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项与 SCM CGH 相关的文献（医药）

2024-07-01·Journal of Intensive Medicine

Septic cardiomyopathy phenotype in the critically ill may depend on antimicrobial resistance

Article

作者: Zakynthinos, George E ; Makris, Demosthenes ; Parisi, Kyriaki ; Zakynthinos, Epaminondas ; Vazgiourakis, Vassileios ; Karavidas, Nikitas ; Tsolaki, Vasiliki ; Gerovasileiou, Efrosini

BackgroundSepsis is a life-threatening organ dysfunction, and septic cardiomyopathy (SCM) may complicate the course of the disease. Infection with multidrug-resistant (MDR) pathogens has been linked with worse outcomes. This study aims to evaluate SCM in patients with infections caused by different antimicrobial-resistant phenotypes.MethodThis retrospective study included patients with sepsis/septic shock, hospitalized, and intubated in the intensive care unit of the University Hospital of Larissa between January 2022 and September 2023 with echocardiographic data during the first two days after infection onset. The patients were divided into two groups: non-MDR-SCM group and MDR-SCM group. The cardiac function was compared between the two groups.ResultA total of 62 patients were included in the study. Forty-four patients comprised the MDR-SCM and 18 the non-MDR-SCM group. Twenty-six patients (41.9%) presented with left ventricular (LV) systolic dysfunction, and ≤35% right ventricular fractional area change (RVFAC) was present in 56.4%. LV systolic function was more severely impaired in the non-MDR-SCM group (left ventricular ejection fraction, 35.8% ±4.9% vs. 45.6%±2.4%, P=0.049; LV outflow tract velocity time integral, [10.1±1.4] cm vs. [15.3±0.74] cm, P=0.001; LV-Strain, -9.02%±0.9% vs. -14.02%±0.7%, P=0.001). The MDR-SCM group presented with more severe right ventricular (RV) dilatation (right ventricular end-diastolic area/left ventricular end-diastolic area, 0.81±0.03 vs. 0.7±0.05, P=0.042) and worse RV systolic function (RVFAC, 32.3%±1.9% vs. 39.6%±2.7%, P=0.035; tricuspid annular plane systolic excursion, [15.9±0.9] mm vs. [18.1±0.9] mm, P=0.165; systolic tissue Doppler velocity measured at the lateral tricuspid annulus, [9.9±0.5] cm/s vs. [13.1±0.8] cm/s, P=0.002; RV-strain, -11.1%±0.7% vs. -15.1%±0.9%, P=0.002).ConclusionSCM related to MDR infection presents with RV systolic dysfunction predominance, while non-MDR-SCM is mainly depicted with LV systolic dysfunction impairment.

2022-11-01·Clinical Microbiology and Infection

External validation of WGS-based antimicrobial susceptibility prediction tools, KOVER-AMR and ResFinder 4.1, for Escherichia coli clinical isolates

Article

作者: Willems, Rob ; Kluytmans, Jan ; Mascaro, Valentina ; Bosch, Thijs ; Verschuuren, Tess

OBJECTIVETo externally validate whole genome sequence-antimicrobial susceptibility testing phenotype prediction tools KOVER-AMR and ResFinder 4.1 for Escherichia coli clinical isolates from Dutch routine care.METHODSA random sample of 234 E. coli and 283 third generation cephalosporin-resistant E. coli isolates from urine and blood were collected (2014-2017). Culture-antimicrobial susceptibility testing was performed using VITEK 2 and BD Phoenix. Sequences were used as input for KOVER-AMR-SCM, KOVER-AMR-CART, and ResFinder 4.1. The concordance, major error rate (MER), and very major error rate (VMER) were calculated, with subsequent comparison to U.S. Food and Drug Administration (FDA) criteria (MER ≤3% and VMER with a 95% confidence interval ≤1.5-≤7.5%).RESULTSResFinder 4.1 performed better than KOVER-AMR-models; however, neither tool achieved overall (V)MERs below FDA criteria. KOVER-AMR-SCM, KOVER-AMR-CART, and ResFinder 4.1, MER (cumulative all antimicrobials) were: 5.1% (4.4-5.9), 4.3% (3.6-5.0), and 5.1% (4.5-5.8), respectively. MERs ≤3% were achieved for 6 (SCM) and 5 (CART) of the 11 tested antimicrobials for KOVER-AMR-models and for 9/13 antimicrobials tested with ResFinder 4.1. KOVER-AMR-SCM, KOVER-AMR-CART, and ResFinder 4.1 cumulative VMERs were: 26% (24-28), 29% (27-31), and 11% (9.2-12). VMERs with a 95% CI ≤ 1.5-≤7.5 were only achieved for 4/13 tested antimicrobials with ResFinder 4.1.DISCUSSIONIn this study, whole genome sequence-antimicrobial susceptibility testing phenotype prediction tools KOVER-AMR and ResFinder 4.1 did not meet the FDA criteria needed for clinical diagnostic use in 517 E. coli clinical isolates from Dutch routine care. The tested tools should be further improved before they can be used for clinical decision making.

2021-11-02·Scandinavian Journal of Clinical and Laboratory Investigation4区 · 医学

Evaluation of the interference of lamotrigine on the analysis of synthetic cannabinoids in urine by the immunoassay method

4区 · 医学

Article

作者: Kurku, Hüseyin ; Aydın Akfırat, Semra ; Kaya, Ömer ; Çetin İlhan, Bilge

We aimed to evaluate the interference of lamotrigine (LMG) on the synthetic cannabinoids metabolite-K2/1 (SCm/K1) urine test by Homogeneous Enzyme Immunoassay (Immune-SCm/K1). This study consists of two parts: case-control and interference effect research. In the case-control study, two groups using LMG and a non-use of LMG were formed, all of them non-SC users. In the interference effect research, four groups were formed by adding either a LMG stock solution or a LMG user's urine to a SCm/K1 negative urine, and Immune-SCm/K1 test calibrators and quality control (QC) materials. Immune-SCm/K1, SCm/K1 by LC/MS-MS and LMG tests were performed on all samples in the study. The case-control study was performed on a total of 55 participants (mean age 39.76 ± 9.84 years). Both groups were statistically insignificant in terms of age and gender. Urine LMG levels were 5.71 ± 10.61 mg/L in the LMG group and <0.30 mg/L in the control group. Immune-SCm/K1 results were 35.84 ± 7.62 ng/mL in the LMG group, <3.00 ng/mL in the control group and the LC/MS-SCm/K1 urine test of both groups were found to be 'NEGATIVE'. Results were interpreted as a cross-reaction in the interference study and a statistically significant relationship was found between LMG levels and Immune-SCm/K1 levels in the SCm/K1 negative samples (groups 1 and 2) (R²= 0.9341 and R²= 0.9941, respectively; p < .001). LMG interference was observed in SCm/K1 positive samples ranging from -6.17 to 714.77%. LMG in the specimen interferes with the Immune-SCm/K1 screening test and causes false positivities.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性移植物抗宿主病	临床2期	韩国	SCM Lifescience Co., Ltd.	2016-09-28
类固醇难治性移植物抗宿主病	临床2期	韩国	SCM Lifescience Co., Ltd.	2016-09-28