Significant Difference In Clinical Status Research Articles

Early Outpatient Administration of Remdesivir Shortens Recovery Time in Patients with Mild to Moderate COVID-19

Background: During COVID-19, healthcare systems in underdeveloped nations had significant challenges and were unlikely to offer the necessary care. It appears that a new, reliable healthcare model that prevents hospitalization is necessary to reduce the pressure that COVID-19 is putting on healthcare systems and patients. More particularly, as Remdesivir's use as an outpatient treatment for mild to severe SARS-CoV-2 infection has rarely been examined; we aimed to investigate in-depth comprehension of the effects of Remdesivir in these cases. Methods: In our two-month cross-sectional study, non-hospitalized patients with mild to moderate COVID-19 who were referred to the hospital for up to 5 days of Remdesivir treatment received 200 mg of Remdesivir intravenously on day 1, followed by 100 mg of Remdesivir once daily for the subsequent 4 days. Patients were divided into groups based on the time of starting Remdesivir treatment after the appearance of symptoms: group 1 less than and equal to 7 days, and group 2 more than 7 days. Two groups were evaluated for a correlation between Remdesivir administration time and clinical symptoms on days 1 and 14 (follow-up visits). Results: The study enrolled 273 eligible patients with a mean age of 47.5 years, of whom 112 were males and 125 were females. Results showed that patients who received Remdesivir in the first 7 days had less dyspnea (P-value<0.0001) and lung involvement (P-value<0.0001) than those who received it after 7 days at the end of the study. Patients who came later to receive Remdesivir also showed higher fatigue, AST, and ALT levels on the first day. Conclusions: Among patients with moderate COVID-19, those who received a 5-day course of Remdesivir within 7 days of the onset of symptoms had a statistically significant difference in clinical status compared with those who received their treatments later. However, the size of this finding has uncertain clinical importance.

Comparison of Efficacy of Remdesivir with Supportive Care Alone in the Treatment of Critically Sick Adult and Child COVID-19 Patients: A Randomized Clinical Trial

Background: Seeking new specific and effective drugs against Coronavirus Diseases-2019 (COVID-19) is of great importance. This study describes the efficacy of remdesivir with supportive care alone in the treatment of critically sick adult and child COVID-19 patients. Method: This study was a one-blind placebo-controlled, randomized clinical trial in adults (aged≥18 years) and children (aged≤12 years) in Iran. Patients were included if they had positive PCR test for SARS-CoV-2 infection, O2 saturation ≤88%, and compatible symptoms. All participants received standard care following national treatment guidelines. The treatment group received remdesivir (200 mg IV on day 1 and followed by 100 mg in single daily infusions). The control group received standard care and an identical volume of placebo infusions (Water for injection) for 5 days. For pediatric patients, the intervention group received remdesivir (5mg/kg on the first day and then 5.2 mg/kg on days 2 to 5). Discharge from the hospital within 10 days of first treatment is considered as the primary endpoint of the study. Admission in the intensive care unit (ICU) is considered as original secondary endpoint of the study. Results: 141 patients were enrolled and randomly assigned to two group (adults; 54 patients in the intervention group vs. 52 patients in the control group, and children; 17 patients in the intervention group vs. 18 patients in the control group). The mean time from the first symptoms until the referral to the hospital in adult patients was 5.61 ± 2.67 day and 4.80±1.48 day for intervention and control groups, respectively. The mean time from the first symptoms until death was reported to be significant and was longer for intervention group than the control group (24.83 ± 11.25 vs. 10.50 ± 2.42 day; p value=0. 012). For children who received remdesivir, the mean time between admission until death was reported to be significant, as the finding highlighted a longer time duration for the intervention group (13.55 ± 0.72 vs. 10.66 ± 0.57 day; p value=0. Mechanicalanical ventilation was used in 17 patients (100%) and 18 patients (100%) in the intervention and control groups, respectively (p value=0.853). Conclusion: Among patients with critical COVID-19, those randomized to a 5-day treatment of remdesivir did have a statistically significant difference in clinical status compared with the control group of both adults and children. Clinical Trial Registration Number: This study is registered in the Iranian Registry of Clinical Trial (No. IRCT 20200405046953N1).

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19

Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown. To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment. Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020. Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d. The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group. Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care. Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance. ClinicalTrials.gov Identifier: NCT04292730.

Prescription Audit of Anti-fungal Treatment of Dermatophytoses in the Dermatology Out Patient Department of a Tertiary Care Hospital

Aims: To study the prescriptions of clinically diagnosed cases of dermatophytoses, to evaluate medical treatment of clinical failure cases, any rise in serum ALT (Alanine aminotransferase) levels associated with usage of oral anti-fungal drugs, availability of drugs in the hospital pharmacy and cost minimization of different oral treatment regimens with Griseofulvin, Fluconazole, Itraconazole and Terbinafine. Settings and design: Dermatology Out Patient Department (OPD) of a tertiary care hospital, single centre prospective cohort observational study. Materials and Methods: 370 patients from the Dermatology Out Patient Department (OPD) diagnosed of dermatophytoses were enrolled. Follow-up was done 3±1 weeks apart, twice for newly diagnosed patients and once for patients on ongoing therapy. Two separate blood samples were collected 3±1 weeks apart for estimation of serum ALT. The prime lesion in each patient was graded as mild, moderate and severe. Patients were categorized as clinically cured, clinically improved, or as clinical failure following treatment. Statistical analysis used: Descriptive statistics, Fischer’s exact test and Wilcoxon’s signed rank test. Results: Azoles were the most commonly prescribed antifungals. Clinical status of patients was independent of the oral antifungal drug received (p > 0.05). A statistically significant difference in clinical status between compliant and non-compliant patients was seen (p < 0.05). A statistically significant increase in serum ALT levels was seen (p < 0.05) however, it was not clinically significant. 55.52% of drugs were unavailable in the hospital formulary. The average expenses per prescription was approximately INR 1123.55. Itraconazole was the most expensive treatment regimen followed by terbinafine and fluconazole. Conclusions: There exists a non-uniformity in the management of dermatophytoses due to lack of adequate guidance and nonavailability of drugs and clinical cure of patients depends upon compliance to therapy.

FLEXIBLE RINGS IN COMPARISON WITH RIGID RINGS IN THE TREATMENT OF FUNCTIONAL TRICUSPID INSUFFICIENCY: TWO DIFFERENT MODELS OF REVERSE REMODELING OF THE RIGHT HEART

Objective. To compare the models of reverse remodeling of the right heart after the tricuspid valve repair with rigid or flexible rings.Material and Methods. During the period from September, 2016 to February, 2018, 308 patients who had indications for intervention on the mitral valve and concomitant tricuspid insufficiency without significant differences in clinical status were randomized into two groups. Patients of both groups underwent intervention on the mitral valve with concomitant tricuspid valve repair by a rigid ring (Rigid group, n=154) or a flexible ring (Flex group, n=154)Results. The perioperative mortality rates were 2.0% in the Rigid group and 2.5% in the Flex group (p=0.504). There was no difference in the pacemaker implantation rate (5.1% vs. 2.6%, p=0.238). Freedom from tricuspid insufficiency recurrence at 12 months follow-up was comparable (96.7% in the Rigid group vs 96.1% in the Flex group, p=0.521). The global systolic function of the right ventricle (fractional change in area, FAC; ejection fraction, EF) significantly increased in both groups (p<0.001 for both group) without significant intergroup differences (p=0.231 for FAC; p=0.156 for EF). Intergroup comparison of the regional systolic function (systolic excursion tricuspid valve, TAPSE; longitudinal velocity of the tricuspid valve, S’) showed that patients of the Flex group had significantly higher increases in the parameters (p<0.001 for TAPSE; p=0.002 for S’).Conclusion. Both types of the devises had low rates of recurrence of tricuspid insufficiency at the midterm follow-up and contributed to the restoration of the global systolic function of the right ventricle. However, the rigid rings due to their design fix the tricuspid valve annulus, which inevitably affects the regional systolic function. In perspective, the flexible rings can function without interfering with the restoration of the natural shape of the tricuspid valve annulus and its uniform contraction during the cardiac cycle, thus ensuring a significant increase in regional systolic function.

Usefulness of Red Cell Width Distribution (RDW) in the Assessment of Children with Pulmonary Arterial Hypertension (PAH)

Red cell width distribution (RDW) is known to be a prognostic marker in adults with pulmonary hypertension. The value of this test in the pulmonary arterial hypertension (PAH) pediatric population was not yet established. The aim of the study was to evaluate the prognostic value of RDW in children with PAH and utility of this parameter in the management. Data were collected retrospectively in 61 patients with PAH confirmed by right heart catheterization. RDW was measured at diagnosis, 3 and 12 months after initial therapy, during and after deterioration if occurred. Results were compared with NTproBNP, WHO-FC and oxygen blood saturation. Mean RDW at baseline was 15.3 ± 2.4% (12.1–24.4, median 14.7%) and was elevated in 29 patients (47%). There were no significant difference in clinical status, NTproBNP and hemodynamic parameters among patient with normal and elevated RDW at diagnosis. Poor negative correlation with SaO2 and SvO2 was shown. After 3 and 12 months of treatment no significant change of RDW level was found despite of statistically significant improvement of WHO-FC and decrease of NTproBNP level (NS). Episodes of clinical deterioration weren’t connected with change of RDW level (16 vs. 15.6% NS). Kaplan–Meier analysis did not show differences in prognosis between patients with normal and elevated RDW. Elevation of RDW was not associated with any measured parameters. Prognostic value of RDW in the pediatric PAH population was not confirmed. Usefulness of RDW in management in PAH pediatric population is limited and required further studies.

Complete percutaneous revascularisation feasibility in ischaemic heart failure is related to improved outcomes: insights from the COMMIT-HF registry.

Heart failure (HF) is a major cause of death in cardiovascular disease. In a post-STICH landscape, we lack data on the role of percutaneous coronary intervention (PCI) in systolic HF patients. Complete revascularisation remains a key unanswered question in ischaemic HF. The COMMIT-HF is an ongoing systolic HF registry (inclusion criteria: HF with left ventricular ejection fraction ≤ 35%, exclusion: acute coronary syndrome). A total of 1798 patients were enrolled. A group of patients with multi-vessel coronary artery disease qualified for PCI were selected and divided into complete (n = 188) and incomplete revascularisation (n = 159) groups. Completeness of revascularisation was defined as successful PCI of every angiographically significant lesion in all arteries with a diameter of ≥ 2 mm without a patent surgical graft. Patients were followed up for a period of at least 12 months with all-cause mortality defined as the primary endpoint. The study groups showed no significant differences in clinical status and echocardiographic parameters, with a lower comorbidity rate in the complete revascularisation group. Procedural characteristics were comparable. There were no significant differences in complication rates. All-cause mortality was significantly lower in the complete revascularisation group after 12-months (6.4% vs. 20.1%, p < 0.001). Multivariate analysis confirmed that achievement of complete revascularisation was an independent factor improving survival (HR 0.39; 95% CI 0.18-0.81, p = 0.01). Percutaneous coronary intervention can be a safe and feasible method of revascularisation in ischaemic HF. Achievement of complete revascularisation with PCI was related to improved outcomes in the analysed patient population.

Clinical Changes in Older Adults During Hospitalization: Responsiveness of the interRAI Acute Care Instrument

To evaluate the responsiveness of the Minimum Data Set interRAI Acute Care (AC), a comprehensive geriatric assessment system, to detect clinical changes in patient status during hospital stays. An explorative secondary data-analysis comparing prospectively collected data with the interRAI AC before hospitalization, upon admission, and at discharge. Clinicians from multiple disciplines in nine geriatric and eight nongeriatric wards of nine acute hospitals performed the assessment. The interRAI AC was administered serially to 256 geriatric inpatients (aged 83.2 ± 5.2; 60% female). Responsiveness (capacity to detect changes in patients) was calculated for the output scales on five domains: activities of daily living (ADLs), cognition, communication, depressive symptoms, and pain. Internal responsiveness was evaluated using the Friedman test and Guyatt technique. Significant differences in clinical status were found for all five domains, based on the Friedman test. Post hoc tests revealed differences between each assessment period, except for cognition and communication from admission to discharge and for depressive symptoms from before admission to discharge. The Guyatt Responsiveness Index showed good to excellent capacity to detect longitudinal changes during hospitalization for cognition, communication, and pain and substantial performance for ADLs and depressive symptoms. In older inpatients, fluctuations in ADLs, cognition, communication, depressive symptoms, and pain can be captured using the interRAI AC output scales, enabling clinicians to evaluate longitudinal changes from admission to discharge and to provide a comparison with patient status before the acute onset of the illness. These results support the use of these scales in geriatric and nongeriatric wards.

Epidemiology and clinical consequences of vancomycin-resistant enterococci in liver transplant patients.

Vancomycin-resistant enterococci (VRE) are increasingly important as pathogens in liver transplant patients. To guide control efforts, we conducted an epidemiological study of the frequency, source, and modes of transmission of VRE at our center. During September 1998 through August 1999, we obtained weekly surveillance cultures from consenting liver transplant patients and surfaces in their rooms. Pooled handwash specimens from personnel also were obtained. Specimens were processed on selective media to detect VRE, and isolates were typed by pulsed field gel electrophoresis. Information was collected from patient records concerning in-hospital treatment and clinical course. Serial cultures were obtained during 33 admissions of 29 patients. VRE were detected in initial specimens from 6 admissions, and nosocomial acquisition of VRE occurred in 12 (44%) of the remaining 27 admissions. Seven different strain types of VRE were detected. The initial site of acquisition was stool in all cases; bile became culture-positive in only two patients. Overall, 16 (55%) of the 29 patients became colonized, usually after transplantation. VRE were detected in environmental cultures during 10 admissions and in 2 of 21 pooled handwashes. No statistically significant differences in clinical status or treatment were found when colonized patients were compared to noncolonized controls. The only VRE infection resulted from a choledochojejunostomy anastomotic leak. Alimentary tract colonization by VRE occurred commonly in liver transplant patients, probably by cross-transmission. The clinical consequences were modest in the patients studied, but colonized transplant patients provide a substantial reservoir for continued VRE transmission in hospitals.

A double-blind placebo-controlled trial of an evening primrose and fish oil combination vs. hydrogenated coconut oil in the management of recurrent seasonal pruritus in horses.

Clinical status and plasma phospholipid fatty acids of 33 horses with seasonal pruritus were investigated following fatty acid supplementation. Principal areas affected by pruritus were mane, tail, head and rump. There were no significant differences in clinical status between horses receiving test and placebo capsules. Horses receiving the test preparation showed significant reduction (weeks 0-12) in linoleic acid (P < 0.05) and significant increases (weeks 0-24) in dihomogammalinolenic acid and alpha linolenic acid (P < 0.05). Placebo-treated horses showed significant reductions (weeks 0-12) in linoleic acid, dihomogammalinolenic acid, arachidonic acid (P < 0.01), eicosapentaenoic acid and docosahexaenoic acid (P < 0.05) and a significant increase (weeks 0-24) in dihomogammalinolenic acid (P < 0.05). Significant differences in the change in plasma phospholipid concentration between test and placebo groups were seen for dihomogammalinolenic acid and docosahexaenoic acid (P < 0.01) between weeks 0 and 12 and for alpha linolenic acid (P < 0.05) between weeks 0 and 24.