scholarly journals Active Comparator Drug

2020 ◽  
Author(s):  
Keyword(s):  
Active Comparator ◽  
Comparator Drug

scholarly journals 1590. Activity of Meropenem-Vaborbactam and Single-Agent Comparators against Enterobacterales Isolates Including KPC-Producing Isolates, from European Patients Hospitalized with Pneumonia Including Ventilator-Associated Pneumonia (2014-2019)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S792-S792
Author(s):  
Dee Shorttidge ◽  
Lalitagauri M Deshpande ◽  
Leonard R Duncan ◽  
Jennifer M Streit ◽  
Mariana Castanheira
Keyword(s):  
Single Agent ◽  
Chemical Diversity ◽  
Ventilator Associated Pneumonia ◽  
Services Research ◽  
Icu Patients ◽  
Active Comparator ◽  
Extended Spectrum Beta Lactamase ◽  
Abdominal Infections ◽  
Hospital Acquired ◽  
Research Grant

Abstract Background Meropenem-vaborbactam (MVB) was recently approved in Europe for the treatment of complicated UTIs, including acute pyelonephritis, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, ventilator-associated pneumonia (VAP), and bacteremia. KPC-producing Enterobacterales (ENT) isolates have disseminated worldwide. We analysed the activity of MVB and single-agent comparators against 6,846 ENT isolates from patients hospitalised with pneumonia (PHP) including VAP in European hospitals (2014–2019). Methods Among 6,846 ENT clinical isolates from PHP collected in 40 European hospitals located in 20 countries that were susceptibility (S) tested using reference broth microdilution methods. Of the carbapenem-resistant isolates submitted to whole genome sequencing, 75 carried blaKPC. ENT isolates were also characterized for an extended spectrum beta-lactamase (ESBL) phenotype as described (CLSI, 2020). EUCAST (2020) interpretive criteria were used. %S from patients in the intensive care unit (ICU), ICU patients with VAP, and non-ICU isolates were also analysed. Results The most common ENT pathogens isolated from PHP were Klebsiella pneumoniae (KPN; n=1,877) and Escherichia coli (EC; n=1,646). The %S of MVB and comparators to ENT, ICU, ICU/VAP, and non-ICU are shown in the table. Overall, 98.2% of ENT were S to MVB. For 3,218 ENT isolates from ICU patients, MVB %S was 96.6% and for 2,627 non-ICU isolates MVB %S was 98.5%. The %S of comparators for ICU vs non-ICU isolates were similar, except for levofloxacin. 29 KPC-producing isolates were from ICU (11 from VAP), 46 were from non-ICU. Most KPC-producing isolates were KPN (n=71; 54 blaKPC-3, 16 blaKPC-2 and 1 blaKPC-12). 4 EC contained blaKPC-3. KPC were from 7 countries, Italy had the highest number of KPC-producing isolates at 42 (56%). MVB inhibited 100% of KPC-producing isolates. Amikacin was the most active comparator against all ENT (94.2%S); colistin was the most active comparator against KPC-producing isolates (79.7%S). Conclusion These results demonstrate MVB has potent activity against ENT isolates from PHP including those producing KPC enzymes and suggest MVB is a useful treatment option for ICU and non-ICU PHP including VAP. Table 1 Disclosures Leonard R. Duncan, PhD, A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Dept of Health and Human Services (Research Grant or Support) Jennifer M. Streit, BS, A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Allergan (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Merck (Research Grant or Support)Paratek Pharma, LLC (Research Grant or Support) Mariana Castanheira, PhD, 1928 Diagnostics (Research Grant or Support)A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Allergan (Research Grant or Support)Allergan (Research Grant or Support)Amplyx Pharmaceuticals (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Fox Chase Chemical Diversity Center (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Merck (Research Grant or Support)Merck (Research Grant or Support)Merck & Co, Inc. (Research Grant or Support)Merck & Co, Inc. (Research Grant or Support)Paratek Pharma, LLC (Research Grant or Support)Pfizer (Research Grant or Support)Qpex Biopharma (Research Grant or Support)

scholarly journals Neurofeedback for tinnitus: Study protocol for a double-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

2019 ◽  
Author(s):  
Martin Jensen ◽  
Eva Hüttenrauch ◽  
Jennifer Schmidt ◽  
Gerhard Andersson ◽  
Mira-Lynn Chavanon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Neurofeedback Training ◽  
Double Blind ◽  
Sound Perception ◽  
Active Comparator ◽  
Randomized Controlled ◽  
Tinnitus Distress ◽  
Training Protocol

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, single-blinded randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks post baseline. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first double-blind, randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes not only to our understanding of the neurological underpinnings of tinnitus, but also to the potentiality of neurofeedback as a therapeutic agent.

scholarly journals SAT-044 Treatment of Hypogonadal Men with a New Oral Testosterone Undecanoate (TU) Formulation Improves Psychosexual, Well-Being and Body Composition and Bone Density Parameters

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Ronald S Swerdloff ◽  
John K Amory ◽  
Adrian S Dobs ◽  
Christina Wang ◽  
Theodore M Danoff ◽  
...  
Keyword(s):  
Body Composition ◽  
Well Being ◽  
Clinic Visit ◽  
Dose Titration ◽  
Mineral Density ◽  
Open Label ◽  
Testosterone Undecanoate ◽  
Active Comparator ◽  
Sf 36 ◽  
The Impact

Abstract Introduction and Objective: A new, first-in-class oral testosterone (T) replacement therapy product [T-undecanoate (TU) capsules] was recently approved by FDA to treat hypogonadal men. Clinical trials were conducted to evaluate, in part, the impact of oral TU therapy on important secondary efficacy endpoints: Psychosexual and/or general well-being (Trial I and II); and body composition and bone mineral density (BMD) (Trial II). Subject and Methods: Hypogonadal men (AM serum T ≤ 300 ng/dL) age 18 to 65 (Trial I) or 75 years old (Trial II) were randomized into open-label, active-comparator (T-gel/solution) trials. Subjects received: Trial 1: Oral TU (n=166) or a topical T solution (n=55) for 4-6 mos.; or Trial II: Oral TU (n=162) or T-gel (n=163) for 12 mos. The starting oral TU dose (with food) was 237 mg, BID in Trial I and 316 mg, BID in Trial II; up to 2 dose-titration opportunities were available to achieve eugonadal T concentrations (assayed by LC-MS/MS). In Trial I, Psychosexual Daily Questionnaires (PDQ) were completed by study subjects for 7 days at baseline and prior to final clinic visit (Day 105-180). In Trial II, the SF-36 well-being questionnaire was completed on Days 0, 30, 90, 180, 270 and 365 and PDQs were completed for 7 days prior to clinic visits on these same days. In Trial II body composition and BMD was assessed by DEXA scan on Days 0, 180 and 365. Safety was monitored by physical exam and standard clinical lab tests. Results: Mean serum T in response to oral TU was 489 ± 155 ng/dL (mean ± SD) (Trial I) and 628 ± 342 ng/dL (Trial II); 84% of subjects in each trial achieved mean T concentrations in the eugonadal range. Statistically significant mean changes from baseline (p<0.0001) for most SF-36 well-being parameters were observed in both oral TU and T-gel groups. Psychosexual questionnaire results also demonstrated statistically significant improvement over baseline (p<0.0001) in most parameters at Day 30 and all timepoints thereafter in both trials. On Days 180 and 365 (v. baseline) oral TU was associated with a significant reduction in fat mass [-1.92 ± 2.79 (SD) and -2.4 ± 3.6 kg, respectively] (p<0.0001) and an increase in lean body mass [+2.87 ± 2.73 and +3.15 ± 2.69 kg, respectively] (p<0.0001). Oral TU increased mean BMD over baseline on Days 180 and 365 in spine [+0.013 ± 0.035 and +0.018 ± 0.042 g/cm2, respectively (p<0.0001)] and hip [+0.006 ± 0.019 and +0.012 ± 0.023 g/cm2, respectively (p<0.0001)]. Oral TU exhibited a safety profile consistent with commonly prescribed topical T-comparators. Modest increases in cuff sBP of 2.8 ± 11.84 (SD) mm Hg and 1.8 ± 10.76 mm Hg were observed in Trial I for both oral TU and the comparator T-solution. Conclusions: Treatment of hypogonadal men with oral TU yielded circulating mean T concentrations in the mid-eugonadal range and significantly improved psychosexual, general well-being, body composition and BMD parameters comparable to transdermal T administration.

scholarly journals Steps Ahead: optimising physical activity in adults with cystic fibrosis: Study Protocol for a pilot randomised trial using wearable technology

2020 ◽  
Vol 3 ◽  
pp. 21
Author(s):  
Maire Curran ◽  
Audrey C. Tierney ◽  
Louise Collins ◽  
Lauren Kennedy ◽  
Ciara McDonnell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cystic Fibrosis ◽  
Remote Monitoring ◽  
Randomised Trial ◽  
Text Message ◽  
Wearable Technology ◽  
Structured Interview ◽  
Text Messages ◽  
University Hospital ◽  
Active Comparator

Background: Physical activity (PA) and exercise are widely documented as key components in the management of cystic fibrosis (CF). In recent years there have been significant improvements in telehealth, in particular; wearable technology,  smartphone use and remote monitoring, all of which may have potential to impact on PA in adults  with CF. The objective of this pilot randomised trial is to explore the effect of wearable technology, which is remotely monitored, combined with personalised text message feedback and goal setting, on PA in adults with CF. Secondary endpoints include lung function, aerobic capacity, quality of life, body composition, wellbeing and sleep. Methods: This is a pilot randomised trial which will be conducted at the University Hospital Limerick, Ireland. Participants will be randomised to the intervention or active comparator after their baseline assessment. The 12-week intervention will consist of wearable technology (Fitbit Charge 2) which is linked to an online monitoring system (Fitabase) that enables the physiotherapist to remotely monitor participant data. The CF physiotherapist will set individualised PA goals with each participant at baseline and will send text message feedback each week. The text messages will be personalised, one-way texts with positive reinforcement on step count attained by the participant. The active comparator group will receive this wearable technology which is also linked to Fitabase; however, no feedback will be provided to participants in this group. Both groups will be re-assessed at 12 weeks. After this point, both groups will continue with the Fitbit alone for a further 12 weeks. Both groups will be re-assessed at 24 weeks. A semi structured interview will assess satisfaction and acceptability of the intervention. Discussion: This is a novel concept which utilises modern technology, remote monitoring and personalised feedback to investigate the effect on PA  in adults with CF.  Trial registration: ClinicalTrials.gov NCT03672058 (14/09/2018)

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