Simon E. Koele
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View article: Optimizing lazertinib therapy through GSTM1 genotyping: a strategy to reduce excess drug exposure and potential toxicity
Optimizing lazertinib therapy through GSTM1 genotyping: a strategy to reduce excess drug exposure and potential toxicity Open
Purpose The combination of lazertinib and amivantamab has shown superior efficacy over first line osimertinib in EGFR-mutated metastatic non-small cell lung cancer, but is associated with significant toxicity and high costs. Lazertinib exp…
View article: A 3-month clofazimine–rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial
A 3-month clofazimine–rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial Open
US National Institutes of Health Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) and the National Institute of Allergy and Infectious Diseases.
View article: Sutezolid in combination with bedaquiline, delamanid, and moxifloxacin for pulmonary tuberculosis (PanACEA-SUDOCU-01): a prospective, open-label, randomised, phase 2b dose-finding trial
Sutezolid in combination with bedaquiline, delamanid, and moxifloxacin for pulmonary tuberculosis (PanACEA-SUDOCU-01): a prospective, open-label, randomised, phase 2b dose-finding trial Open
EDCTP2 programme funded by the EU; German Ministry for Education and Research; German Center for Infection Research; and Nederlandse Organisatie voor Wetenschappelijk Onderzoek.
View article: Cardiac safety of bedaquiline, delamanid and moxifloxacin co-administered with or without varying doses of sutezolid or delpazolid for the treatment of drug-susceptible TB
Cardiac safety of bedaquiline, delamanid and moxifloxacin co-administered with or without varying doses of sutezolid or delpazolid for the treatment of drug-susceptible TB Open
Introduction Many drugs for the treatment of TB prolong the QTc interval, which is associated with an increased risk of developing a life-threatening arrhythmia known as torsades de pointes. Sutezolid and delpazolid are novel oxazolidinone…
View article: Neuromyelitis optica causing vision loss during TB treatment with sutezolid: evidence of aberrant immunity following infection
Neuromyelitis optica causing vision loss during TB treatment with sutezolid: evidence of aberrant immunity following infection Open
Contains fulltext : 319485.pdf (Publisher’s version ) (Open Access)
View article: Population pharmacokinetics and exposure–response relationship of the antituberculosis drug BTZ-043
Population pharmacokinetics and exposure–response relationship of the antituberculosis drug BTZ-043 Open
Introduction BTZ-043 is a first-in-class benzothiazinone for the treatment of TB with demonstrated early bactericidal activity. BTZ-043 is metabolized into two major metabolites: M1 and M2. The aim of this study was to characterize the pha…
View article: Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043–02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial
Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043–02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial Open
EDCTP2 programme; German Ministry for Education and Research; German Center for Infection Research; InfectControl; Bavarian Ministry for Science and the Arts; Swiss State Secretariat for Education, Research, and Innovation; and Nederlandse…
View article: A loading dose of clofazimine to rapidly achieve steady-state-like concentrations in patients with nontuberculous mycobacterial disease
A loading dose of clofazimine to rapidly achieve steady-state-like concentrations in patients with nontuberculous mycobacterial disease Open
Objectives Clofazimine is a promising drug for the treatment of nontuberculous mycobacterial (NTM) diseases. Accumulation of clofazimine to reach steady-state plasma concentrations takes months. A loading dose may reduce the time to steady…
View article: Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial
Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial Open
Introduction Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria trans…
View article: Power to identify exposure‐response relationships in phase <scp>IIa</scp> pulmonary tuberculosis trials with multi‐dimensional bacterial load modeling
Power to identify exposure‐response relationships in phase <span>IIa</span> pulmonary tuberculosis trials with multi‐dimensional bacterial load modeling Open
Adequate power to identify an exposure‐response relationship in a phase IIa clinical trial for pulmonary tuberculosis (TB) is important for dose selection and design of follow‐up studies. Currently, it is not known what response marker pro…
View article: Early bactericidal activity studies for pulmonary tuberculosis: A systematic review of methodological aspects
Early bactericidal activity studies for pulmonary tuberculosis: A systematic review of methodological aspects Open
A milestone in the development of novel antituberculosis drugs is the demonstration of early bactericidal activity (EBA) in a phase IIa clinical trial. The significant variability in measurements of bacterial load complicates data analysis…
View article: Pharmacokinetically guided dosing to improve the efficacy of brigatinib in non‐small cell lung cancer patients
Pharmacokinetically guided dosing to improve the efficacy of brigatinib in non‐small cell lung cancer patients Open
Contains fulltext : 288320.pdf (Publisher’s version ) (Open Access)
View article: Pharmacokinetically‐guided dosing to improve the efficacy of brigatinib in non‐small cell lung cancer patients
Pharmacokinetically‐guided dosing to improve the efficacy of brigatinib in non‐small cell lung cancer patients Open
Brigatinib was recently approved for the treatment of anaplastic lymphoma kinase‐positive non‐small cell lung cancer and is dosed according to a one‐dose‐fits‐all paradigm. We aimed to identify a pharmacokinetically‐guided precision dosing…
View article: Pharmacokinetically-guided dosing to improve the efficacy of brigatinib in non-small cell lung cancer patients
Pharmacokinetically-guided dosing to improve the efficacy of brigatinib in non-small cell lung cancer patients Open
Brigatinib was recently approved for the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer and is dosed according to a one-dose-fits-all paradigm. We aimed to identify a pharmacokinetically-guided precision dosing…
View article: Pharmacokinetics and probability of target attainment for micafungin in normal-weight and morbidly obese adults
Pharmacokinetics and probability of target attainment for micafungin in normal-weight and morbidly obese adults Open
We present easy-to-use dose recommendations for obese patients, based on both weight and target MIC, that result in adequate exposure in patients with body weight up to 190 kg.