A5089384391- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Antibiotic Resistance in Bacteria
- Antibiotic Use and Resistance
- Bacterial Identification and Susceptibility Testing
- Meta-analysis and systematic reviews
- HIV Research and Treatment
- Antibiotics Pharmacokinetics and Efficacy
- HIV-related health complications and treatments
- Advanced Causal Inference Techniques
- Antiplatelet Therapy and Cardiovascular Diseases
- HIV/AIDS Research and Interventions
- Optimal Experimental Design Methods
- Pneumonia and Respiratory Infections
- Urinary Tract Infections Management
- Acute Ischemic Stroke Management
- HIV/AIDS drug development and treatment
- Antimicrobial Resistance in Staphylococcus
- Venous Thromboembolism Diagnosis and Management
- Pharmaceutical studies and practices
- Pneumocystis jirovecii pneumonia detection and treatment
- Statistical Methods and Bayesian Inference
- Lipoproteins and Cardiovascular Health
- Ethics in Clinical Research
- Clinical Laboratory Practices and Quality Control
George Washington University
1998-2025
Milken Institute
2018-2025
Penn Highlands DuBois
2024
University of Michigan
2023
Medical University of South Carolina
2023
Massachusetts General Hospital
2023
National Health and Family Planning Commission
2023
Duke University Hospital
2023
Duke Medical Center
2023
National Clinical Research
2022
Objectives: HAART suppresses HIV viral replication and restores immune function. The effects of on neurological disease are less well understood. aim this study was to assess the prevalence incidence neurocognitive impairment in individuals who initiated as part an AIDS clinical trial. Design: A prospective cohort HIV-positive patients enrolled randomized antiretroviral trials, Clinical Trials Group (ACTG) Longitudinal Linked Randomized (ALLRT) study. Methods: We examined association between...
The efficacy of ceftazidime-avibactam—a cephalosporin–β-lactamase inhibitor combination with in vitro activity against Klebsiella pneumoniae carbapenemase–producing carbapenem-resistant Enterobacteriaceae (CRE)—compared colistin remains unknown. Patients initially treated either ceftazidime-avibactam or for CRE infections were selected from the Consortium on Resistance Against Carbapenems and other (CRACKLE), a prospective, multicenter, observational study. Efficacy, safety, benefit-risk...
Trials have evaluated the use of clopidogrel and aspirin to prevent stroke after an ischemic or transient attack (TIA). In a previous trial, ticagrelor was not better than in preventing vascular events death TIA. The effect combination on prevention has been well studied.We conducted randomized, placebo-controlled, double-blind trial involving patients who had mild-to-moderate acute noncardioembolic stroke, with National Institutes Health Stroke Scale (NIHSS) score 5 less (range, 0 42,...
<h3>Importance</h3> Deutetrabenazine is a novel molecule containing deuterium, which attenuates CYP2D6 metabolism and increases active metabolite half-lives may therefore lead to stable systemic exposure while preserving key pharmacological activity. <h3>Objective</h3> To evaluate efficacy safety of deutetrabenazine treatment control chorea associated with Huntington disease. <h3>Design, Setting, Participants</h3> Ninety ambulatory adults diagnosed manifest disease baseline total maximal...
To determine whether antiretroviral regimens with good central nervous system (CNS) penetration control HIV in cerebrospinal fluid (CSF) and improve cognition.Multisite longitudinal observational study.Research clinics.One hundred one individuals advanced beginning or changing a new potent regimen were enrolled the study. Data for 79 participants analyzed. Participants underwent structured history neurological examination, venipuncture, lumbar puncture, neuropsychological tests at entry, 24,...
Clinical trials that compare strategies to optimize antibiotic use are of critical importance but limited by competing risks distort outcome interpretation, complexities noninferiority trials, large sample sizes, and inadequate evaluation benefits harms at the patient level. The Antibacterial Resistance Leadership Group strives overcome these challenges through innovative trial design. Response adjusted for duration risk (RADAR) is a novel methodology utilizing superiority design 2-step...
A noninferiority study is often used to investigate whether a treatment's efficacy or safety profile acceptable compared with an alternative therapy regarding the time clinical event. The empirical quantification of treatment difference for such routinely based on hazard ratio (HR) estimate. HR, which not relative risk, may be difficult interpret clinically, especially when underlying proportional hazards assumption violated. precision HR estimate depends primarily number observed events but...
Polymyxins including colistin are an important "last-line" treatment for infections caused by carbapenem-resistant Klebsiella pneumoniae (CRKp). Increasing use of has led to resistance this cationic antimicrobial peptide.
BackgroundCarbapenem-resistant Pseudomonas aeruginosa (CRPA) is a global threat, but the distribution and clinical significance of carbapenemases are unclear. The aim this study was to define characteristics outcomes CRPA infections frequency impact harboured by CRPA.MethodsWe conducted an observational, prospective cohort isolated from bloodstream, respiratory, urine, or wound cultures patients at 44 hospitals (10 countries) between Dec 1, 2018, Nov 30, 2019. Clinical data were abstracted...
<h3>Importance</h3> Childhood community-acquired pneumonia (CAP) is usually treated with 10 days of antibiotics. Shorter courses may be effective fewer adverse effects and decreased potential for antibiotic resistance. <h3>Objective</h3> To compare a short (5-day) vs standard (10-day) treatment strategy CAP in young children. <h3>Design, Setting, Participants</h3> Randomized double-blind placebo-controlled clinical trial outpatient clinic, urgent care, or emergency settings 8 US cities. A...
Efavirenz is a commonly used antiretroviral drug that causes neurologic side effects in more than 50% of patients.To characterize efavirenz-associated symptoms randomized, controlled study initial treatment.Substudy double-blind, trial combination regimens (A5095) was performed between March 2001 and January 2002.Multicenter academic clinical units.HIV-infected patients who were initiating therapy the context trial.Neuropsychological performance measures, including Digit Symbol Substitution...
Objective: Differences in antiretroviral distribution into the central nervous system (CNS) may impact neurocognitive status. We assessed relationship between estimates of therapy penetration CNS, using a published ranking system, and status HIV-positive participants with plasma HIV-1 RNA (vRNA) suppression. Design: Participants at least 6 weeks ongoing drug use vRNA less than 50 copies/ml (N = 2636; 83% male, median baseline CD4 T cells: 244 cells/μl) had one neuroscreen assessment [Trail...
Prior studies have shown improved neurocognition with initiation of antiretroviral treatment (ART) in HIV. We hypothesized that stopping ART would be associated poorer neurocognitive function.Neurocognitive function was assessed as part ACTG 5170, a multicenter, prospective observational study HIV-infected subjects who elected to discontinue ART. Eligible had CD4 count >350 cells/mm(3), HIV RNA viral load <55,000 cp/mL, and were on (>or=2 drugs) for >or=6 months. Subjects stopped at entry...
Objectives: To estimate neuropathic sign/symptom rates with initiation of combination antiretroviral therapy (cART) in HIV-infected ART-naive patients, and to investigate risk factors for: peripheral neuropathy symptomatic (SPN), recovery from neuropathy/SPN after neurotoxic ART (nART) discontinuation, the absence while on nART. Design: AIDS Clinical Trials Group (ACTG) Longitudinal Linked Randomized Trial participants who initiated cART randomized trials for patients were annually screened...
Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. The selection trial structure requires logic and creativity. Common structural designs discussed.
Distal sensory polyneuropathy (DSP) is the most common neurologic complication of human immunodeficiency virus (HIV) infection. Risk factors for DSP have not been adequately defined in era highly active antiretroviral therapy.The authors evaluated 101 subjects with advanced HIV infection over 48 weeks. Assessments included a brief peripheral neuropathy (PN) screen (BPNS), examination, nerve conduction studies, quantitative testing (QST), and skin biopsies quantitation epidermal fiber...
ABSTRACT Carbapenem resistance in Gram-negative bacteria is on the rise United States. A regional network was established to study microbiological and genetic determinants of clinical outcomes hospitalized patients with carbapenem-resistant (CR) Klebsiella pneumoniae a prospective, multicenter, observational study. To this end, predefined characteristics were recorded K. isolates analyzed for strain typing mechanism determination. In 14-month period, 251 included. While most admitted from...
Abstract Background Vancomycin is the most commonly administered antibiotic in hospitalized patients, but optimal exposure targets remain controversial. To clarify therapeutic range, this study evaluated association between vancomycin and outcomes patients with methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. Methods This was a prospective, multicenter (n = 14), observational of 265 adults MRSA bacteremia treated vancomycin. The primary outcome treatment failure (TF), defined...
Abstract Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in practice. In this article, we report on an Initiative Methods, Measurement, and Pain Assessment Clinical Trials (IMMPACT) consensus meeting organized by Analgesic, Anesthetic, Addiction Trial Translations, Innovations, Opportunities, Networks, purpose which was recommend approaches that facilitate interpretation RCTs. We review issues consider when drawing...
In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of effects new treatments in realistic settings. Accomplishing pragmatism requires better summaries totality evidence ways that consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to analysis is analyze efficacy safety separately then combine these analyses into assessment. Many assume this...