Nicole F Maranchick
· Director and Clinical Assistant ProfessorUniversity of Florida · Pharmacotherapy and Translational Research
Active 2022–2026
About
Nicole F Maranchick, Pharm.D., received her Doctor of Pharmacy degree from the University of Florida and completed an Infectious Disease Fellowship at the Infectious Disease Pharmacokinetics Laboratory (IDPL). She currently serves as a Clinical Assistant Professor and Co-Director of the IDPL within the Department of Pharmacotherapy and Translational Research at the College of Pharmacy, University of Florida. Her research focuses on antimicrobial pharmacokinetics and dose optimization, with an emphasis on anti-tuberculosis drugs and beta-lactams. She is actively involved in therapeutic drug monitoring and clinical consultations for the treatment of infections such as tuberculosis, HIV, and fungal infections. Additionally, she has contributed as a co-investigator to research addressing the optimization of Dolutegravir-based antiretroviral therapy in children and adolescents.
Research topics
- Internal medicine
- Medicine
- Microbiology
- Biology
- Intensive care medicine
- Chemistry
- Anesthesia
- Pharmacology
Selected publications
Antimicrobial Agents and Chemotherapy · 2026-03-02
articleOpen access1st authorCorrespondingABSTRACT Tuberculosis (TB) is a major cause of morbidity and mortality in children globally. This study developed models to describe population pharmacokinetics (PK) of pyrazinamide (PZA) and ethambutol (EMB) in children with TB with or without human immunodeficiency virus (HIV) coinfection. Ghanaian children with TB with or without HIV coinfection receiving first-line antituberculosis therapy for at least 4 weeks had blood samples collected at time 0 (pre-dose), 1-, 2-, 4-, 8-, and 12-h post-dose. PZA and EMB concentrations were quantified using liquid chromatography tandem mass spectrometry. Nonlinear mixed-effects models were applied to describe the population PK using Monolix2024R1. Maximum concentrations ( C max ) and 24-h area under the time concentration curve (AUC 0–24 ) were compared to published values in adults. A total of 85 children (41 TB, 44 TB/HIV) were included. The median (range) age was 5 years (0.3–14.5), and 61.2% were male. Median (range) doses for PZA and EMB were 31.6 (21.4–49.7) and 21.4 mg/kg (14.3–34.2), respectively. PZA was best described using a one-compartment model and EMB by a two-compartment model. Allometric scaling improved both model fits. Children with TB/HIV coinfection had approximately 18.5% faster PZA clearance and 25% faster EMB clearance. Optimized dosing to achieve adult-equivalent exposures required higher-than-currently recommended doses, particularly among children in the lowest weight bands and those with HIV. The population PK of PZA and EMB was well described by the final models, but the higher-than-currently recommended doses needed to achieve adult-equivalent exposures raise concerns regarding risks for drug-associated toxicities and will require further evaluation.
P-1244. PK/PD Target Attainment of Beta-lactams in Patients With Versus Without Obesity
Open Forum Infectious Diseases · 2026-01-01
articleOpen accessAbstract Background Previous studies have shown that patients with obesity are at risk for subtherapeutic beta-lactam concentrations, owing to the pharmacokinetic (PK) changes in factors such as volume of distribution and clearance. Beta-lactam therapeutic drug monitoring (TDM) has been utilized as a strategy to reduce PK variability and individualize dosing regimens, although data exploring the use of TDM in this population are limited. This study sought to evaluate the role of TDM in patients with obesity and its impact on pharmacokinetic/pharmacodynamic (PK/PD) target attainment of beta-lactams. Methods This single-center, retrospective, matched cohort study included adult patients with obesity (OB) and patients without (non-OB) who had routine TDM performed for cefepime (FEP), piperacillin-tazobactam (PTZ), or meropenem (MEM). Underweight patients were excluded. Patients were matched by drug, ICU status, renal function, and early (≤ 72 hours) or late TDM ( > 72 hours). The primary outcome compared PK/PD target attainment in OB vs non-OB. This study assessed two PK/PD targets (100% fT≥ MIC and 100% fT≥ 4xMIC). Secondary outcomes included treatment failure, length of stay, in-hospital mortality, adverse events, and 30-day readmission. Results Of 199 matched pairs of patients, 298 (75%) patients received FEP, 48 (12%) received PTZ, and 52 (13%) received MEM. There was no difference in attainment of 100% fT≥ MIC between OB vs non-OB at 84% (n=168) and 85% (n=170), respectively. Target attainments were similar, yet much lower for 100% fT≥ 4xMIC in OB vs non-OB at 53% (n=106) and 54% (n=108) respectively. OB and non-OB receiving PTZ had the lowest overall rates of attainment of 100% fT≥ MIC (69%) and 100% fT≥ 4xMIC (29%). More OB experienced any adverse effect compared to non-OB at 48 (24%) and 30 (15%), respectively (p = 0.02). Specifically, rates of nephrotoxicity were greater in OB vs non-OB (15% vs. 6%, p< 0.01). There were no differences in any other secondary outcomes. Conclusion PK/PD target attainment was comparable between OB and non-OB in this study, but lowest with PTZ, highlighting the need for targeted TDM in these patients. OB experienced significantly higher rates of adverse effects, including nephrotoxicity, emphasizing the importance of TDM in improving patient safety. Disclosures Venugopalan Veena, PharmD, Merck: Grant/Research Support Kathryn DeSear, PharmD, Abbvie: Advisor/Consultant|Biomerieux: Advisor/Consultant|Cormedix: Speaking|GSK: Advisor/Consultant|Shionogi: Speaking
JAIDS Journal of Acquired Immune Deficiency Syndromes · 2026-03-19
articleBACKGROUND: The pharmacokinetics (PK) and safety of dolutegravir in children with HIV (CWH) weighing at least 20 kg with and without tuberculosis (TB) treated according to World Health Organization dosing guidelines was examined. METHODS: CWH on dolutegravir 50 mg once-daily and those with HIV/TB on 50 mg twice-daily with rifampin-based therapy were enrolled. Five to six blood samples were collected within the dosing interval after 4 weeks (period-1) and 7-8 months (period-2) of dolutegravir-based therapy. Dolutegravir concentrations were measured using LCMS/MS and PK parameters calculated by non-compartmental analysis. Geometric mean ratio (GMR) with 95% confidence interval (CI) was used to compare PK parameters on and off TB treatment and between the two groups. RESULTS: Of 25 participants, 52% had TB coinfection. Rifampin coadministration increased dolutegravir clearance by 86%. GMRs (95% CI) of area under the concentration-time curve (AUC0-24h) and trough concentration (Ctrough) of dolutegravir twice-daily with rifampin versus once-daily alone were 1.07 (0.79-1.44) and 1.45 (0.89-2.35), respectively. Comparing HIV/TB versus HIV, dolutegravir AUC0-24h and Ctrough GMRs (respectively) were 1.69 (0.99-2.90) and 2.50 (1.19-5.26) in period-1 and 1.26 (0.85-1.85) and 1.57 (0.53-4.68) in period-2. Two participants with HIV and none with HIV/TB had Ctrough <0.32mg/L. Overall, 92% of participants with HIV/TB and 82% with HIV achieved viral load <400 copies/mL at 6 months of dolutegravir-based therapy, with no dolutegravir discontinuations. CONCLUSIONS: Twice-daily dolutegravir with rifampin was associated with higher trough concentrations in children with HIV/TB than in controls. Standard dose of dolutegravir with rifampin needs to be investigated.
Open Forum Infectious Diseases · 2026-01-01
articleOpen accessAbstract Background Clinical failures with cefazolin have been linked to the CzIE where increased bacterial inoculum leads to elevated cefazolin minimum inhibitory concentrations (MICs) against MSSA. The role of therapeutic drug monitoring (TDM) in optimizing cefazolin dosing in the context of the CzIE remains unclear. This study aimed to determine the prevalence of the CzIE and compare cefazolin pharmacokinetic/pharmacodynamic (PK/PD) target attainment in MSSA isolates with and without the CzIE. Methods A single-center, retrospective review included adults (≥18 years) with MSSA bacteremia admitted between Jun 2021–Dec 2023 who received cefazolin and had steady-state serum cefazolin concentrations. CzIE was defined as a cefazolin MIC ≥16 µg/mL at high inoculum (10⁷ CFU/mL) and ≤8 µg/mL at standard inoculum (10⁵ CFU/mL). Total cefazolin concentrations were adjusted for 80% protein binding. PK/PD targets were 100%fT≥MIC and 100%fT≥4×MIC (100% free drug time above MIC or 4x MIC, respectively). Results Among 51 patients included in the analysis, median age was 61 years (IQR, 39.5–70.5). Common bacteremia sources included endocarditis (n=11, 21.6%), musculoskeletal (n=11, 21.6%), and pneumonia (n=9, 17.6%). Nine isolates (17.6%) exhibited the CzIE and 32 (62.7%) were blaZ-positive. Median cefazolin trough was 5.9 µg/mL (IQR, 3.2–11.6) in CzIE infected vs. 4.2 µg/mL (IQR, 2.5–10.4) in patients infected with a non-CzIE isolate. In CzIE isolates, modal MICs were 1 µg/mL at standard inoculum and 16 µg/mL at high inoculum; in non-CzIE, both were 0.5 µg/mL. In the CzIE group at standard inoculum, 100% (n=9) achieved 100%fT≥MIC and 66.7% (n=6) achieved 100%fT≥4×MIC; at high inoculum, 11.1% (n=1) achieved 100%fT≥MIC and none achieved 100%fT≥4×MIC. In the non-CzIE group at standard inoculum, 88.1% (n=37) achieved 100%fT≥MIC and 73.8% (n=31) achieved 100%fT≥4×MIC; at high inoculum 88.1% (n=37) achieved 100%fT≥MIC and 61.9% (n=26) achieved 100%fT≥4×MIC. Conclusion Cefazolin PK/PD target attainment was markedly reduced in patients with CzIE isolates at high inoculum. These findings underscore the potential utility of TDM in detecting suboptimal cefazolin exposure and the need to consider alternative dosing strategies in this setting. Disclosures Cesar A. Arias, MD/PhD, UptoDate: Royalties
Cefepime Pharmacokinetics in Patients Receiving Extracorporeal Membrane Oxygenation
Therapeutic Drug Monitoring · 2025-10-03
article1st authorCorrespondingBACKGROUND: Data on the effect of extracorporeal membrane oxygenation (ECMO) on cefepime concentration and protein binding are limited. This study aimed to describe the pharmacokinetics of cefepime in patients receiving ECMO, with or without renal replacement therapy. METHODS: Participants receiving ECMO were prospectively enrolled in the thoracic and lung transplant intensive care unit at the University of Florida Health-Shands Hospital in Gainesville, FL. Serum samples for drug quantification were collected at 1, 2, 4, 6, and 8 hours after the completion of cefepime infusion, pre- and post-ECMO oxygenator. The total and free drug concentrations in the ultrafiltrate were measured using liquid chromatography-tandem mass spectrometry at the University of Florida Infectious Disease Pharmacokinetics Laboratory. RESULTS: Six patients who underwent venovenous ECMO were enrolled in the study. The median [interquartile range (IQR)] age and weight were 56.5 years (48-61.8) and 80.6 kg (75.4-90.6), respectively, and 67% were female. All patients received 2 g of cefepime infused over 30 minutes, with dosing intervals per renal function. The median (IQR) time between ECMO initiation and pharmacokinetic sampling was 3.5 days (2.5-24.7). None of the patients underwent renal replacement therapy during sampling. Minimal differences in cefepime concentrations pre- and postoxygenator were observed (<20% difference for all paired samples; median 3.5%). The median (IQR) protein-binding rates for cefepime both pre- [6.2% (2.6-10.8)] and post- [8.7% (2.5-13.4)] oxygenator were lower than previously published estimates of 20%. CONCLUSIONS: No differences in pre- or post-ECMO oxygenator cefepime concentrations were observed. The median protein-binding values were less than previously published values.
Antibiotics · 2025-05-01 · 2 citations
articleOpen accessPurpose: To assess the impact of beta-lactam therapeutic drug monitoring (TDM) timing and therapy adjustment on clinical cure and 30-day mortality. Methods: This was a prospective study of critically ill patients admitted to the University of Florida Health Shands Hospital intensive care unit (ICU) between 2021 and 2022, ≥18 years old, and requiring beta-lactam therapy for a suspected or confirmed infection. Beta-lactam concentrations were measured per standard of care, pharmacokinetic/dynamic (PK/PD) target attainment was calculated, and therapy was adjusted if needed. Multiple regression and time-to-event (TTE) analyses were performed. Results: A total of 297 infection episodes from 268 patients were included. The mean (SD) age was 56 years (17), weight was 82 kg (32), and 14% received renal replacement therapy. The most common infection source was the lung, and the most common beta-lactam was cefepime. The most common infusion duration was 30 min. The median (IQR) time to first TDM was 2.7 days (1.7–4.7). Fifty-seven percent of patients required therapy adjustment. Increases in beta-lactam dose, frequency, or infusion duration were associated with lower 30-day mortality compared to continuing the same regimen (aOR 0.30, p = 0.015). Delay in performing TDM was associated with lower probability of clinical cure (aOR 0.92, p = 0.0023). Patients who had the regimen increased had shorter hospital stay compared to those who had it decreased. Timing of beta-lactam TDM in ICU patients was a significant predictor of clinical cure, while adjusting beta-lactam therapy to achieve higher exposure was a significant predictor of 30-day mortality.
ERJ Open Research · 2025-07-24
articleOpen access<title>Extract</title> The treatment of nontuberculous mycobacterial (NTM) disease is lengthy and requires multiple drugs, often associated with adverse effects [1]. Treatment failure and recurrence are also common [2]. Drug over- and underexposure may contribute to toxicity and treatment failure [3–5]. Still, information on the use of therapeutic drug monitoring (TDM) - the individualisation of drug dosing based on drug concentration measurements - to optimise NTM disease management is very limited. Only a few studies have examined its clinical implications [3–6]. Given that ERS and ESCMID guidelines suggest considering TDM for NTM pulmonary disease, investigating its clinical application, utility, and barriers is highly relevant. We aimed to describe the global use of TDM in NTM disease management and to identify barriers to its broader implementation.
High Time for Higher-Dose Rifampin
Clinical Infectious Diseases · 2025-01-03 · 1 citations
letter1st authorCorresponding637: USE OF THERAPEUTIC DRUG MONITORING TO OPTIMIZE MEROPENEM DOSING IN HOSPITALIZED PATIENTS
Critical Care Medicine · 2025-01-01
articleLinezolid Dosing and Pharmacokinetics in North American Patients With Tuberculosis
Clinical Infectious Diseases · 2025-01-20 · 5 citations
article1st authorCorrespondingBACKGROUND: Linezolid is recommended in treatment regimens for rifampin- or multidrug-resistant tuberculosis (TB). However, considerable pharmacokinetic variability exists, and long-term use is limited by adverse effects. This study evaluates the pharmacokinetics of linezolid in patients with TB from an international therapeutic drug monitoring (TDM) service. METHODS: Linezolid trough, 2-hour, and 6-hour postdose clinical samples from across North America were tested by the University of Florida Infectious Disease Pharmacokinetics Laboratory. Total serum concentrations were measured using liquid chromatography-tandem mass spectrometry. TDM was performed, and measurements were compared to typical linezolid concentrations including a trough value of <2 μg/mL and peak value between 12 and 26 μg/mL. RESULTS: From January 2019 to December 2023, 1604 linezolid samples from 500 patients and 817 unique TDM occasions were analyzed. Trough concentrations were measured on 670 samples (median, 1.19 [range, 0.00-20.06] μg/mL), and 232 troughs (34.6%) were >2 μg/mL. Among trough samples from linezolid dosing of 600 mg daily, 43.2% were >2 μg/mL. Of 600 peak samples, 264 (44%) were outside the typical range, most (89%) being subtherapeutic at <12 μg/mL. CONCLUSIONS: High serum linezolid trough concentrations were measured in approximately one-third of samples and in >40% of those taking the recommended dose. More than 40% of peak concentrations were outside typical range, of which 89% were <12 μg/mL. This study demonstrates that TDM can be used to identify patients with serum linezolid concentrations outside of targeted ranges, allowing clinicians to make appropriate dose adjustments to improve outcomes.
Frequent coauthors
- 25 shared
Charles A. Peloquin
University of Florida
- 16 shared
Mohammad H. Al‐Shaer
Zagazig University
- 13 shared
Veena Venugopalan
Florida College
- 12 shared
Awewura Kwara
University of Florida
- 12 shared
Bethany R. Shoulders
University of Florida Health Science Center
- 10 shared
Carolina B. Maciel
University of Florida
- 10 shared
Timothy Felton
Manchester University NHS Foundation Trust
- 8 shared
Stephan Eisenschenk
Florida College
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