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Article ; Online: Re-evaluating the role of isoniazid in treatment of pulmonary tuberculosis.

Heysell, Scott / Mpgama, Stellah

The Lancet. Microbe

2020 Volume 1, Issue 2, Page(s) e49–e50

Language	English
Publishing date	2020-06-08
Publishing country	England
Document type	Journal Article
ISSN	2666-5247
ISSN (online)	2666-5247
DOI	10.1016/S2666-5247(20)30034-3
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Article ; Online: Geographic Variation and Environmental Predictors of Nontuberculous Mycobacteria in Laboratory Surveillance, Virginia, USA, 2021-2023

Mullen, Brendan / Houpt, Eric R / Colston, Josh / Becker, Lea / Johnson, Sharon / Young, Laura / Hearn, Jasie / Falkinham, Joe / Heysell, Scott K

Emerging infectious diseases

2024 Volume 30, Issue 3, Page(s) 548–554

Abstract: Because epidemiologic and environmental risk factors for nontuberculous mycobacteria (NTM) have been reported only infrequently, little information exists about those factors. The state of Virginia, USA, requires certain ecologic features to be included ... ...

Abstract	Because epidemiologic and environmental risk factors for nontuberculous mycobacteria (NTM) have been reported only infrequently, little information exists about those factors. The state of Virginia, USA, requires certain ecologic features to be included in reports to the Virginia Department of Health, presenting a unique opportunity to study those variables. We analyzed laboratory reports of Mycobacterium avium complex (MAC) and M. abscessus infections in Virginia during 2021-2023. MAC/M. abscessus was isolated from 6.19/100,000 persons, and 2.37/100,000 persons had MAC/M. abscessus lung disease. M. abscessus accounted for 17.4% and MAC for 82.6% of cases. Saturated vapor pressure was associated with MAC/M. abscessus prevalence (prevalence ratio 1.414, 95% CI 1.011-1.980; p = 0.043). Self-supplied water use was a protective factor (incidence rate ratio 0.304, 95% CI 0.098-0.950; p = 0.041). Our findings suggest that a better understanding of geographic clustering and environmental water exposures could help develop future targeted prevention and control efforts.
MeSH term(s)	Nontuberculous Mycobacteria ; Virginia/epidemiology ; Mycobacterium avium Complex ; Mycobacterium abscessus ; Water ; Carbamates ; Pyrazines ; Pyridines
Chemical Substances	canertinib dihydrochloride (ICJ93X8X90) ; Water (059QF0KO0R) ; Carbamates ; Pyrazines ; Pyridines
Language	English
Publishing date	2024-02-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	1380686-5
ISSN	1080-6059 ; 1080-6040
ISSN (online)	1080-6059
ISSN	1080-6040
DOI	10.3201/eid3003.231162
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Article ; Online: Having walked the path.

Heysell, Scott K

Annals of internal medicine

2014 Volume 161, Issue 5, Page(s) 374–375

MeSH term(s)	Communication ; Critical Illness/psychology ; Humans ; Male ; Physician-Patient Relations ; Religion ; Treatment Refusal/psychology
Language	English
Publishing date	2014-09-02
Publishing country	United States
Document type	Journal Article ; Personal Narratives
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/M14-0326
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Article ; Online: Adenosine deaminase negative pleural tuberculosis: a case report.

Boggs, Zachary H / Heysell, Scott / Eby, Joshua / Arnold, Christopher

BMC infectious diseases

2021 Volume 21, Issue 1, Page(s) 575

Abstract: Background: A pleural fluid adenosine deaminase (ADA) has been used globally to assist in the diagnosis of a tuberculous pleural effusion (TPE) with a notable negative predictive value.: Case presentation: We report a case of a patient with a ... ...

Abstract	Background: A pleural fluid adenosine deaminase (ADA) has been used globally to assist in the diagnosis of a tuberculous pleural effusion (TPE) with a notable negative predictive value. Case presentation: We report a case of a patient with a negative pleural fluid ADA who was found to have culture-positive and biopsy-proven Mycobacterium tuberculosis. Conclusions: This case shows the importance of pursuing gold standard diagnostic studies when clinical suspicion remains high despite negative preliminary testing. We further describe gaps in research to improve pleural fluid biomarkers for TPE.
MeSH term(s)	Adenosine Deaminase/analysis ; Adenosine Deaminase/metabolism ; Adult ; Antitubercular Agents/therapeutic use ; Biomarkers/analysis ; Biopsy/methods ; Exudates and Transudates ; Humans ; Male ; Mycobacterium tuberculosis/isolation & purification ; Pleural Effusion/diagnosis ; Pleural Effusion/microbiology ; Predictive Value of Tests ; Treatment Outcome ; Tuberculosis, Pleural/diagnosis ; Tuberculosis, Pleural/drug therapy ; Tuberculosis, Pleural/enzymology
Chemical Substances	Antitubercular Agents ; Biomarkers ; Adenosine Deaminase (EC 3.5.4.4)
Language	English
Publishing date	2021-06-15
Publishing country	England
Document type	Case Reports ; Journal Article
ISSN	1471-2334
ISSN (online)	1471-2334
DOI	10.1186/s12879-021-06276-4
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Article ; Online: Challenges and a potential solution to perform drug susceptibility testing of omadacycline against nontuberculous mycobacteria.

Shankar, Prem / Singh, Sanjay / Boorgula, Gunavanthi D / Gumbo, Tawanda / Heysell, Scott K / Srivastava, Shashikant

Tuberculosis (Edinburgh, Scotland)

2022 Volume 137, Page(s) 102269

Abstract: Background: Minimum inhibitory concentration (MIC) of slow growing mycobacteria (SGM) often do not correlate with the treatment response. Among the challenges is the identification of MIC of drugs that degrade in solution faster than the doubling time ... ...

Abstract	Background: Minimum inhibitory concentration (MIC) of slow growing mycobacteria (SGM) often do not correlate with the treatment response. Among the challenges is the identification of MIC of drugs that degrade in solution faster than the doubling time of the SGM. Methods: First, we identified the rate of omadacycline degradation in solution, and its effect on the rapidly growing methicillin resistant Staphylococcus aureus (MRSA). We then identified doubling times versus MICs for Mycobacterium abscessus, M. avium, and M. kansasii, with and without supplementation for degraded drug. Results: Omadacycline concentration in solution declined ∼50% over 24hr. In the MRSA experiments, omadacycline demonstrated 66.48 ± 19.38% loss in potency over 24hr, confirming the degradation rate in solution. M. abscessus had a doubling time of 8.75 ± 1.23hr and the omadacycline MIC after 24hr of incubation was 2mg/L with and without 50% daily drug supplementation, indicating that drug degradation had no effect on this rapid grower. The doubling time for M. avium was 29.52hr (95% confidence interval (CI): 23.18-33.89hr) and 31.15hr (95%CI: 19.45-38.49 hr) for M. kansasii. The M. avium MICs ±50% daily omadacycline supplementation were 1mg/L and 0.5mg/L on day 7, whereas the M. kansasii MICs ±50% daily supplementation were >128mg/L and 32mg/L on day 7. Conclusion: Omadacycline degradation in solution leads to falsely high MICs when SGM doubling time exceed the drug degradation rates in solution. The challenge could be overcome by daily drug supplementation to account for the loss of potency, which is laborious, or perhaps stabilizing the drug from degradation.
MeSH term(s)	Humans ; Nontuberculous Mycobacteria ; Microbial Sensitivity Tests ; Mycobacterium Infections, Nontuberculous/diagnosis ; Mycobacterium Infections, Nontuberculous/drug therapy ; Mycobacterium Infections, Nontuberculous/microbiology ; Methicillin-Resistant Staphylococcus aureus ; Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Mycobacterium tuberculosis
Chemical Substances	omadacycline (090IP5RV8F) ; Anti-Bacterial Agents
Language	English
Publishing date	2022-10-04
Publishing country	Scotland
Document type	Letter ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2046804-0
ISSN	1873-281X ; 1472-9792
ISSN (online)	1873-281X
ISSN	1472-9792
DOI	10.1016/j.tube.2022.102269
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Article ; Online: Omadacycline Pharmacokinetics/Pharmacodynamics in the Hollow Fiber System Model and Potential Combination Regimen for Short Course Treatment of Mycobacterium kansasii Pulmonary Disease.

Singh, Sanjay / Gumbo, Tawanda / Boorgula, Gunavanthi D / Shankar, Prem / Heysell, Scott K / Srivastava, Shashikant

Antimicrobial agents and chemotherapy

2022 Volume 66, Issue 9, Page(s) e0068722

Abstract: The 12-month therapy duration for the treatment of Mycobacterium kansasii pulmonary disease calls for more efficacious drugs for better treatment outcomes and to shorten the therapy duration. We performed (i) omadacycline MIC with M. kansasii ATCC 12478 ... ...

Abstract	The 12-month therapy duration for the treatment of Mycobacterium kansasii pulmonary disease calls for more efficacious drugs for better treatment outcomes and to shorten the therapy duration. We performed (i) omadacycline MIC with M. kansasii ATCC 12478 strain and 21 clinical isolates, (ii) dose-response study in the hollow fiber system model of M. kansasii (HFS-
MeSH term(s)	Anti-Bacterial Agents/therapeutic use ; Humans ; Lung Diseases/microbiology ; Microbial Sensitivity Tests ; Moxifloxacin/pharmacology ; Moxifloxacin/therapeutic use ; Mycobacterium kansasii ; Tetracyclines
Chemical Substances	Anti-Bacterial Agents ; Tetracyclines ; omadacycline (090IP5RV8F) ; Moxifloxacin (U188XYD42P)
Language	English
Publishing date	2022-08-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/aac.00687-22
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Zs.A 809: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Isoniazid pharmacokinetics/pharmacodynamics as monotherapy and in combination regimen in the hollow fiber system model of Mycobacterium kansasii.

Boorgula, Gunavanthi D / Singh, Sanjay / Shankar, Prem / Gumbo, Tawanda / Heysell, Scott K / Srivastava, Shashikant

Tuberculosis (Edinburgh, Scotland)

2022 Volume 138, Page(s) 102289

Abstract: Background: There is limited high quality evidence to guide the optimal doses of drugs for the treatment of Mycobacterium kansasii pulmonary disease (Mkn-PD).: Methods: We performed (1) minimum inhibitory concentration experiment, (2) isoniazid dose- ... ...

Abstract	Background: There is limited high quality evidence to guide the optimal doses of drugs for the treatment of Mycobacterium kansasii pulmonary disease (Mkn-PD). Methods: We performed (1) minimum inhibitory concentration experiment, (2) isoniazid dose-response study using the hollow fiber system model (HFS-Mkn) to determine PK/PD optimized exposure, and (3) another HFS-Mkn study to determine the efficacy of high dose isoniazid (15 mg/kg/day) with standard dose rifampin (10 mg/kg/day) and ethambutol (15 mg/kg/day). Inhibitory sigmoid maximal effect model and linear regression was used for data analysis. Results: MIC of the 20 clinical isolates ranged between 0.5 mg/L to 32 mg/L. In the HFS-Mkn, isoniazid monotherapy failed to control the bacterial growth beyond day 7. On day 7, when the maximal Mkn kill was observed, the optimal isoniazid exposure for Mkn kill was calculated as 24hr area under the concentration-time curve to the MIC of 12.41. Target attainment probability of 300 mg/day dose fell below 90% above the MIC of 1 mg/L. High dose isoniazid combination sterilized the HFS-Mkn in 30-days with a kill rate of -0.15 ± 0.02 log Conclusion: Despite initial kill, isoniazid monotherapy failed due to resistance emergence. Our pre-clinical model derived results suggest that higher than currently recommended 300 mg/day isoniazid dose may achieve better clinical efficacy against Mkn-PD.
MeSH term(s)	Humans ; Isoniazid/therapeutic use ; Antitubercular Agents/therapeutic use ; Mycobacterium kansasii ; Mycobacterium tuberculosis ; Ethambutol/pharmacology ; Ethambutol/therapeutic use ; Lung Diseases ; Microbial Sensitivity Tests
Chemical Substances	Isoniazid (V83O1VOZ8L) ; Antitubercular Agents ; Ethambutol (8G167061QZ)
Language	English
Publishing date	2022-12-01
Publishing country	Scotland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2046804-0
ISSN	1873-281X ; 1472-9792
ISSN (online)	1873-281X
ISSN	1472-9792
DOI	10.1016/j.tube.2022.102289
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Article ; Online: New approach to rifampicin stability and first-line anti-tubercular drug pharmacokinetics by UPLC-MS/MS.

Karaźniewicz-Łada, Marta / Kosicka-Noworzyń, Katarzyna / Rao, Prakruti / Modi, Nisha / Xie, Yingda L / Heysell, Scott K / Kagan, Leonid

Journal of pharmaceutical and biomedical analysis

2023 Volume 235, Page(s) 115650

Abstract: Successful tuberculosis (TB) therapy requires achieving sufficient exposure to multiple drugs. Limited stability of several first-line anti-TB drugs might compromise reliable therapeutic drug monitoring (TDM). We developed and validated a sensitive and ... ...

Abstract	Successful tuberculosis (TB) therapy requires achieving sufficient exposure to multiple drugs. Limited stability of several first-line anti-TB drugs might compromise reliable therapeutic drug monitoring (TDM). We developed and validated a sensitive and selective UPLC-MS/MS method for simultaneous quantification of isoniazid (INH), pyrazinamide (PZA), rifampicin (RIF), its metabolite 25-desacetylrifampicin and degradation products: rifampicin quinone and 3-formyl-rifampicin. Analysis was completed from a very small plasma volume (20 µL) using only protein precipitation with methanol. Chromatographic separation was achieved on a Kinetex Polar C18 column (2.6 µm; 150 × 3 mm) with a mobile phase consisting of 5 mM ammonium acetate and acetonitrile, both containing 0.1 % formic acid, in gradient elution. The analytes were detected using a positive ionization mode by multiple reaction monitoring. The LLOQ for RIF and its degradation products was 0.1 µg/mL, 0.05 µg/mL for INH, and 0.2 µg/mL for PZA. The method was validated based on the FDA guidance. The application of the method was confirmed in the analysis of RIF, INH, and PZA, as well as RIF metabolism/degradation products in plasma samples of patients with TB. Based on the detailed stability study of the analyzed compounds at various storage conditions, we proposed recommendations for handling the plasma and serum samples in TDM and other pharmacokinetic studies.
MeSH term(s)	Humans ; Rifampin ; Chromatography, High Pressure Liquid ; Chromatography, Liquid ; Tandem Mass Spectrometry ; Antitubercular Agents
Chemical Substances	Rifampin (VJT6J7R4TR) ; Antitubercular Agents
Language	English
Publishing date	2023-08-15
Publishing country	England
Document type	Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2023.115650
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Article ; Online: Decision Analytic Modeling for Global Clinical Trial Planning: A Case for HIV-Positive Patients at High Risk for

Keim-Malpass, Jessica / Heysell, Scott K / Thomas, Tania A / Lobo, Jennifer M / Mpagama, Stellah G / Muzoora, Conrad / Moore, Christopher C

International journal of environmental research and public health

2023 Volume 20, Issue 6

Abstract: Sepsis is a significant cause of mortality among people living with human immunodeficiency virus (HIV) in sub-Saharan Africa. In the planning period prior to the start of a large multi-country clinical trial studying the efficacy of the immediate empiric ...

Abstract	Sepsis is a significant cause of mortality among people living with human immunodeficiency virus (HIV) in sub-Saharan Africa. In the planning period prior to the start of a large multi-country clinical trial studying the efficacy of the immediate empiric addition of anti-tuberculosis therapy to standard-of-care antibiotics for sepsis in people living with HIV, we used decision analysis to assess the costs and potential health outcome impacts of the clinical trial design based on preliminary data and epidemiological parameter estimates. The purpose of this analysis was to highlight this approach as a case example where decision analysis can estimate the cost effectiveness of a proposed clinical trial design. In this case, we estimated the impact of immediate empiric anti-tuberculosis (TB) therapy versus the diagnosis-dependent standard of care using three different TB diagnostics: urine TB-LAM, sputum Xpert-MTB/RIF, and the combination of LAM/Xpert. We constructed decision analytic models comparing the two treatment strategies for each of the three diagnostic approaches. Immediate empiric-therapy demonstrated favorable cost-effectiveness compared with all three diagnosis-dependent standard of care models. In our methodological case exemplar, the proposed randomized clinical trial intervention demonstrated the most favorable outcome within this decision simulation framework. Applying the principles of decision analysis and economic evaluation can have significant impacts on study design and clinical trial planning.
MeSH term(s)	Humans ; Mycobacterium tuberculosis ; HIV Infections/complications ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; Uganda/epidemiology ; Tuberculosis/diagnosis ; Tuberculosis/drug therapy ; Tuberculosis/epidemiology ; HIV Seropositivity ; Sepsis/drug therapy ; Sepsis/epidemiology ; Sputum/microbiology ; Sensitivity and Specificity
Language	English
Publishing date	2023-03-13
Publishing country	Switzerland
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2175195-X
ISSN	1660-4601 ; 1661-7827
ISSN (online)	1660-4601
ISSN	1661-7827
DOI	10.3390/ijerph20065041
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Article ; Online: Development and Validation of a UPLC-MS/MS Method for Therapeutic Drug Monitoring, Pharmacokinetic and Stability Studies of First-Line Antituberculosis Drugs in Urine.

Abouzid, Mohamed / Kosicka-Noworzyń, Katarzyna / Karaźniewicz-Łada, Marta / Rao, Prakruti / Modi, Nisha / Xie, Yingda L / Heysell, Scott K / Główka, Anna / Kagan, Leonid

Molecules (Basel, Switzerland)

2024 Volume 29, Issue 2

Abstract: Tuberculosis (TB) remains one of the leading global causes of mortality. Several methods have been established to detect anti-TB agents in human plasma and serum. However, there is a notable absence of studies analyzing TB drugs in urine. Thus, our ... ...

Abstract	Tuberculosis (TB) remains one of the leading global causes of mortality. Several methods have been established to detect anti-TB agents in human plasma and serum. However, there is a notable absence of studies analyzing TB drugs in urine. Thus, our objective was to validate a method for quantifying first-line anti-TB agents: isoniazid (INH), pyrazinamide (PZA), ethambutol (ETH), and rifampicin (RIF), along with its metabolite 25-desacetylrifampicin, and degradation products: rifampicin quinone and 3-formyl-rifampicin in 10 µL of urine. Chromatographic separation was achieved using a Kinetex Polar C18 analytical column with gradient elution (5 mM ammonium acetate and acetonitrile with 0.1% formic acid). Mass spectrometry detection was carried out using a triple-quadrupole tandem mass spectrometer operating in positive ion mode. The lower limit of quantification (LLOQ) was 0.5 µg/mL for INH, PZA, ETH, and RIF, and 0.1 µg/mL for RIF's metabolites and degradation products. The method was validated following FDA guidance criteria and successfully applied to the analysis of the studied compounds in urine of TB patients. Additionally, we conducted a stability study of the anti-TB agents under various pH and temperature conditions to mimic the urine collection process in different settings (peripheral clinics or central laboratories).
MeSH term(s)	Humans ; Drug Monitoring ; Rifampin/therapeutic use ; Chromatography, Liquid ; Liquid Chromatography-Mass Spectrometry ; Tandem Mass Spectrometry ; Antitubercular Agents/therapeutic use ; Ethambutol
Chemical Substances	Rifampin (VJT6J7R4TR) ; Antitubercular Agents ; Ethambutol (8G167061QZ)
Language	English
Publishing date	2024-01-09
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1413402-0
ISSN	1420-3049 ; 1431-5165 ; 1420-3049
ISSN (online)	1420-3049
ISSN	1431-5165 ; 1420-3049
DOI	10.3390/molecules29020337
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