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4. The positive and negative consequences of stress and its relationship with coping in medical students: A qualitative study.

Author

Manley, Amy Elizabeth, Biddle, Lucy, Savović, Jelena, and Moran, Paul

Abstract

AbstractRates of mental health problems among medical students have prompted efforts to reduce stress during medical training. However, stress can be motivating and is a feature of clinical work. This qualitative study explores what makes an experience stressful, and how medical students respond to such experiences. In-depth interviews were conducted with a purposive sample of 15 medical students. Experiences were distressing when they threatened students’ self-perception, goals or coping mechanisms, or when they reminded the student of distressing past events. Moderate stress was motivating and could build resilience. Students selected coping mechanisms based on their availability, acceptability, likely outcome and their previous experience of using these mechanisms. Social support, extra-curricular activities and exercise were helpful. High levels of distress, poor self-esteem and course factors, including remote placements, impaired engagement with coping strategies. Perception of stressors as being insurmountable or beyond one’s control, led to increasing distress and the adoption of avoidant coping strategies. University strategies need to consider the beneficial effects of stress and seek to bolster coping resources as well as minimising unnecessary sources of stress. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Synthetic Cannabinoid Receptor Agonists are Monoamine Oxidase‐A Selective Inhibitors

Author

Hindson, Sarah A, primary, Andrews, Rachael C, additional, Danson, Michael J, additional, van der Kamp, Marc W, additional, Manley, Amy E, additional, Sutcliffe, Oliver B, additional, Haines, Tom S F, additional, Freeman, Tom P, additional, Scott, Jennifer, additional, Husbands, Stephen M, additional, Blagbrough, Ian S, additional, Anderson, JL Ross, additional, Carbery, David R, additional, and Pudney, Christopher R, additional

Published
2023
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22. Omadacycline for Community-Acquired Bacterial Pneumonia

Author

Stets, Roman, primary, Popescu, Monica, additional, Gonong, Joven R., additional, Mitha, Ismail, additional, Nseir, William, additional, Madej, Andrzej, additional, Kirsch, Courtney, additional, Das, Anita F., additional, Garrity-Ryan, Lynne, additional, Steenbergen, Judith N., additional, Manley, Amy, additional, Eckburg, Paul B., additional, Tzanis, Evan, additional, McGovern, Paul C., additional, and Loh, Evan, additional

Published
2019
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23. Omadacycline for Acute Bacterial Skin and Skin-Structure Infections

Author

O’Riordan, William, primary, Green, Sinikka, additional, Overcash, J. Scott, additional, Puljiz, Ivan, additional, Metallidis, Symeon, additional, Gardovskis, J., additional, Garrity-Ryan, Lynne, additional, Das, Anita F., additional, Tzanis, Evan, additional, Eckburg, Paul B., additional, Manley, Amy, additional, Villano, Stephen A., additional, Steenbergen, Judith N., additional, and Loh, Evan, additional

Published
2019
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29. A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of IV to Oral Omadacycline to Moxifloxacin for the Treatment of Adult Subjects with CABP (The OPTIC Study)

Author

Stets, Roman, primary, Popescu, Monica, additional, Gonong, Joven, additional, Mitha, Ismail, additional, Nseir, William, additional, Madej, Andrzej, additional, Kirsch, Courtney, additional, Das, Anita, additional, Garrity-Ryan, Lynne, additional, Steenbergen, Judith N, additional, Manley, Amy, additional, Eckburg, Paul, additional, Villano, Stephen, additional, Tzanis, Evan, additional, McGovern, Paul, additional, and Loh, Evan, additional

Published
2017
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38. Pharmacokinetics and Safety of Omadacycline in Subjects with Impaired Renal Function

Author

Berg, Jolene K., Tzanis, Evan, Garrity-Ryan, Lynne, Bai, Stephen, Chitra, Surya, Manley, Amy, and Villano, Stephen

Abstract

ABSTRACTMany antibiotics require dose adjustments in patients with renal impairment and/or in those undergoing hemodialysis. Omadacycline, the first aminomethylcycline antibiotic in late-stage clinical development, displays activity against a broad spectrum of bacterial pathogens, including drug-resistant strains. Data from completed phase 3 studies of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) showed intravenous (i.v.) to once-daily oral omadacycline to be clinically effective and well tolerated. To determine if the dosing of omadacycline should be adjusted in patients with impaired renal function, a phase 1 study examining the pharmacokinetics (PK) and safety of i.v. omadacycline (100 mg) was conducted in subjects with end-stage renal disease (ESRD) on stable hemodialysis (n= 8) and in matched healthy subjects (n= 8). i.v. administration of omadacycline produced similar plasma concentration-time profiles in subjects with ESRD and healthy subjects. Further, in subjects with ESRD, similar values of the PK parameters were observed when omadacycline was administered i.v. after or before dialysis. The mean area under the concentration-time curve from time zero extrapolated to infinity in plasma was 10.30 μg · h/ml when omadacycline was administered to ESRD subjects after dialysis, 10.20 μg · h/ml when omadacycline was administered to ESRD subjects before dialysis, and 9.76 μg · h/ml when omadacycline was administered to healthy subjects. The mean maximum observed concentration of omadacycline in plasma in ESRD subjects was 1.88 μg/ml when it was administered after dialysis and 2.33 μg/ml when it was administered before dialysis, and in healthy subjects it was 1.92 μg/ml. The 100-mg i.v. dose of omadacycline was generally safe and well tolerated in both ESRD and healthy subjects. This study demonstrates that no dose adjustment is necessary for omadacycline in patients with impaired renal function or on days when patients are receiving hemodialysis.

Published
2017
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39. Safety and Pharmacokinetics of the Aminomethylcycline Antibiotic Omadacycline Administered to Healthy Subjects in Oral Multiple-Dose Regimens

Author

Bundrant, Lu Ann, Tzanis, Evan, Garrity-Ryan, Lynne, Bai, Stephen, Chitra, Surya, Manley, Amy, and Villano, Stephen

Abstract

ABSTRACTOmadacycline, a first-in-class aminomethylcycline antibiotic, is related to tetracyclines but is structurally modified to circumvent mechanisms of resistance to tetracyclines. Omadacycline demonstrates potent activity against a broad range of pathogens, including drug-resistant strains, and is in late-stage development for treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Previous studies support an intravenous-to-oral transition regimen with 300-mg once-daily oral dosing. This phase 1 study investigated the pharmacokinetics and safety/tolerability of multiple oral omadacycline doses higher than 300 mg. Using a 3-period crossover design, healthy adults were randomized to receive oral omadacycline at 300, 450, and 600 mg in variable sequence (n= 26) or placebo (n= 7) once daily for 5 consecutive days per period. In plasma, omadacycline maximum concentration and total exposure increased with increasing dose but were less than dose proportional. The kinetics of omadacycline plasma accumulation were similar between dose levels; exposure on day 5 was ∼50% higher than that on day 1. Omadacycline plasma concentrations on day 1 of 450-mg dosing were similar to those on day 5 of 300-mg dosing. All doses were generally well tolerated, but the 600-mg dose was associated with more gastrointestinal adverse events.

Published
2017
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40. An Evaluation of the Efficacy, Safety, and Tolerability of Desvenlafaxine in the Long-term Treatment of Elderly Outpatients With Major Depressive Disorder.

Author

Ferguson, James, Tourian, Karen A., Manley, Amy L., Padmanabhan, S. Krishna, and Nichols, Alice

Subjects
*ANTIDEPRESSANTS, *MENTAL depression, *MENTAL health of older people, *CLINICAL drug trials, *DRUG efficacy, *DRUG side effects, *DRUG tolerance
Abstract

Objective: To evaluate the safety and tolerability (primary) and efficacy (secondary) of desvenlataxine (administered as desvenlafaxine succinate) treatment in elderly patients with major depressive disorder (MDD). Methods: Outpatients ≥65 years of age with MDD received open-label, flexible-dose desvenlafaxine 100 or 200 mg/day for ≤6 months. Safety and tolerability were assessed,, the primary efficacy measure was the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score. Results: Safety analyses included 52 patients (mean age=72.9 years). The most frequently reported adverse events were mild or moderate nausea (40%), dizziness (25%), and headache (21%). Primary and secondary adverse events led to discontinuation of treatment for 18 (35~) patients. The most common adverse events cited as reasons for withdrawal were hypertension (10%) and nausea (10%). There were few clinically important changes in vital signs, laboratory assessments, or electrocardiograms. Treatment with desvenlafaxine reduced mean total HAM-D17 scores through month 2; these improvements were maintained without dose escalation. Conclusion: Desvenlataxine was safe, well tolerated, and effective in elderly patients with MDD. [ABSTRACT FROM AUTHOR]

Published
2010

41. Omadacycline for Acute Bacterial Skin and Skin-Structure Infections.

Author

O'Riordan, William, Green, Sinikka, Overcash, J. Scott, Puljiz, Ivan, Metallidis, Symeon, Gardovskis, J., Garrity-Ryan, Lynne, Das, Anita F., Tzanis, Evan, Eckburg, Paul B., Manley, Amy, Villano, Stephen A., Steenbergen, Judith N., and Loh, Evan

Subjects
*ANTIBIOTICS, *CLINICAL trials, *COMMUNICABLE diseases, *COMPARATIVE studies, *DRUG resistance in microorganisms, *DRUG administration, *INTRAVENOUS therapy, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *SKIN diseases, *EVALUATION research, *TETRACYCLINES, *RANDOMIZED controlled trials, *BLIND experiment, *METHICILLIN-resistant staphylococcus aureus, *THERAPEUTICS
Abstract

Background: Acute bacterial skin and skin-structure infections are associated with substantial morbidity and health care costs. Omadacycline, an aminomethylcycline antibiotic that can be administered once daily either orally or intravenously, is active against pathogens that commonly cause such infections, including antibiotic-resistant strains.Methods: In this double-blind trial, we randomly assigned adults with acute bacterial skin and skin-structure infections (in a 1:1 ratio) to receive omadacycline (100 mg given intravenously every 12 hours for two doses, then 100 mg given intravenously every 24 hours) or linezolid (600 mg given intravenously every 12 hours). A transition to oral omadacycline (300 mg every 24 hours) or oral linezolid (600 mg every 12 hours) was allowed after 3 days; the total treatment duration was 7 to 14 days. The primary end point was an early clinical response at 48 to 72 hours, defined as survival with a reduction in lesion size of at least 20% without rescue antibacterial therapy. A secondary end point was an investigator-assessed clinical response at the post-treatment evaluation 7 to 14 days after the last dose, with clinical response defined as survival with resolution or improvement in signs or symptoms of infection to the extent that further antibacterial therapy was unnecessary. For both end points, the noninferiority margin was 10 percentage points.Results: In the modified intention-to-treat population, omadacycline (316 patients) was noninferior to linezolid (311 patients) with respect to early clinical response (rate of response, 84.8% and 85.5%, respectively; difference, -0.7 percentage points; 95% confidence interval [CI], -6.3 to 4.9). Omadacycline also was noninferior to linezolid with respect to investigator-assessed clinical response at the post-treatment evaluation in the modified intention-to-treat population (rate of response, 86.1% and 83.6%, respectively; difference, 2.5 percentage points; 95% CI, -3.2 to 8.2) and in the clinical per-protocol population (96.3% and 93.5%, respectively; difference, 2.8 percentage points; 95% CI, -1.0 to 6.9). In both groups, the efficacy of the trial drug was similar for methicillin-susceptible and methicillin-resistant Staphylococcus aureus infections. Adverse events were reported in 48.3% of the patients in the omadacycline group and in 45.7% of those in the linezolid group; the most frequent adverse events in both groups were gastrointestinal (in 18.0% and 15.8% of the patients in the respective groups).Conclusions: Omadacycline was noninferior to linezolid for the treatment of acute bacterial skin and skin-structure infections and had a similar safety profile. (Funded by Paratek Pharmaceuticals; OASIS-1 ClinicalTrials.gov number, NCT02378480 .). [ABSTRACT FROM AUTHOR]

Published
2019
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