Trial reportAntimicrobial agents and chemotherapy2012
Population pharmacokinetics and pharmacodynamics of ofloxacin in South African patients with multidrug-resistant tuberculosis.
Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Pharmacokinetics of antiretroviral and tuberculosis drugs in children with HIV/TB co-infection: a systematic review.The Journal of antimicrobial chemotherapy · 2020Pooled it
- Fluoroquinolones for treating tuberculosis (presumed drug-sensitive).The Cochrane database of systematic reviews · 2013Pooled it
- Moxifloxacin population pharmacokinetics and model-based comparison of efficacy between moxifloxacin and ofloxacin in African patients.Antimicrobial agents and chemotherapy · 2014Trial
- Using Mycobacterium tuberculosis Single-Nucleotide Polymorphisms To Predict Fluoroquinolone Treatment Response.Antimicrobial agents and chemotherapy · 2019Article
- Optimal Regimens and Cutoff Evaluation of Tildipirosin AgainstFrontiers in pharmacology · 2018Article
- Treating tuberculosis with high doses of anti-TB drugs: mechanisms and outcomes.Annals of clinical microbiology and antimicrobials · 2017Review
- Pharmacokinetics of Levofloxacin in Multidrug- and Extensively Drug-Resistant Tuberculosis Patients.Antimicrobial agents and chemotherapy · 2017Article
- A review of computational and mathematical modeling contributions to our understanding of Mycobacterium tuberculosis within-host infection and treatment.Current opinion in systems biology · 2017Article
- A Multilaboratory, Multicountry Study To Determine MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing of Selected First-Line Antituberculosis Drugs, Second-Line Injectables, Fluoroquinolones, Clofazimine, and Linezolid.Journal of clinical microbiology · 2016Article
- Pharmacokinetics and Safety of Ofloxacin in Children with Drug-Resistant Tuberculosis.Antimicrobial agents and chemotherapy · 2015Article
- Outcomes and use of therapeutic drug monitoring in multidrug-resistant tuberculosis patients treated in virginia, 2009-2014.Tuberculosis and respiratory diseases · 2015Article
- Subtherapeutic concentrations of first-line anti-TB drugs in South African children treated according to current guidelines: the PHATISA study.The Journal of antimicrobial chemotherapy · 2015Observational
- Article
- Understanding pharmacokinetics to improve tuberculosis treatment outcome.Expert opinion on drug metabolism & toxicology · 2014Review
- Discordance across several methods for drug susceptibility testing of drug-resistant Mycobacterium tuberculosis isolates in a single laboratory.Journal of clinical microbiology · 2014Article
- Plasma drug activity in patients on treatment for multidrug-resistant tuberculosis.Antimicrobial agents and chemotherapy · 2014Article
- Application of quantitative second-line drug susceptibility testing at a multidrug-resistant tuberculosis hospital in Tanzania.BMC infectious diseases · 2013Article
- New susceptibility breakpoints and the regional variability of MIC distribution in Mycobacterium tuberculosis isolates.Antimicrobial agents and chemotherapy · 2012Article
- Minimum inhibitory concentration, pharmacokinetics/pharmacodynamics and therapeutic drug monitoring: An integrated approach for multidrug-resistant tuberculosis.Lung India : official organ of Indian Chest SocietyArticle
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Authors and funding
10 authors at 5 institutions in 3 countries.
Funding
Abstract
Despite the important role of fluoroquinolones and the predominant use of ofloxacin for treating multidrug-resistant tuberculosis in South Africa, there are limited data on ofloxacin pharmacokinetics in patients with multidrug-resistant tuberculosis, no ofloxacin pharmacokinetic data from South African patients, and no direct assessment of the relationship between ofloxacin pharmacokinetics and the MIC of ofloxacin of patient isolates. Our objectives are to describe ofloxacin pharmacokinetics in South African patients being treated for multidrug-resistant tuberculosis and assess the adequacy of ofloxacin drug exposure with respect to the probability of pharmacodynamic target attainment (area under the time curve/MIC ratio of at least 100). Sixty-five patients with multidrug-resistant tuberculosis were recruited from 2 hospitals in South Africa. We determined the ofloxacin MICs for the Mycobacterium tuberculosis isolates from baseline sputum specimens. Patients received daily doses of 800 mg ofloxacin, in addition to other antitubercular drugs. Patients underwent pharmacokinetic sampling at steady state. NONMEM was used for data analysis. The population pharmacokinetics of ofloxacin in this study has been adequately described. The probability of target attainment expectation in the study population was 0.45. Doubling the dose to 1,600 mg could increase this to only 0.77. The currently recommended ofloxacin dose appeared inadequate for the majority of this study population. Studies to assess the tolerability of higher doses are warranted. Alternatively, ofloxacin should be replaced with more potent fluoroquinolones.
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